510(k) · Cleared
Recalled · Class II · 2020First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp), Methamphetamine (Met), Ecstasy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
First Check Diagnostics, LLC · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Dec 29, 2005 as substantially equivalent to K050186 (Ameditech, Inc., 2005) after a 147-day review. Its family tree reaches back 1 generation to 2005. 18 later devices descend from it. It has been recalled 86 times.
- Decided
- Dec 29, 2005
- Review
- 147 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- 86
- Predicates
- 1
Its longest line of descent runs back 1 generation to K050186 (2005). 18 later devices descend from it, 13 citing it directly.
- Root · 1 generation backK050186 Ameditech Immutest Multi-Drug Screen Panel IiiAmeditech, Inc. · 2005 · Recalled
- This deviceK052115 First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc)…First Check Diagnostics, LLC · 2005
- Descendant · cites it directly · 4 of its ownK143187 Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen…Healgen Scientific,, LLC · 2015
- Descendant · cites it directly · 4 of its ownK142280 Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen…Healgen Scientific,, LLC · 2014
- Descendant · cites it directly · 4 of its ownK141647 Healgen Coc One Step Cocaine Test Strip:Morhpine Test Strip…Healgen Scientific,, LLC · 2014
- Descendant · cites it directly · 4 of its ownK140546 Healgen THC One Step Marijuana Test , Healgen Mamp One Step…Healgen Scientific,, LLC · 2014 · Recalled
- Descendant · cites it directly · 3 of its ownK150096 Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card)…Healgen Scientific,, LLC · 2015
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
2014high 7 (2015) · low 0 (2018)2026
Most influential descendants
Showing 5 of 18 · See all- K143187Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test…Healgen Scientific,, LLC · 2015 · cites it directly4descendants
- K142280Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip…Healgen Scientific,, LLC · 2014 · cites it directly4descendants
- K141647Healgen Coc One Step Cocaine Test Strip:Morhpine Test Strip (Cassette, Cup, Dip Card)Healgen Scientific,, LLC · 2014 · cites it directly4descendants
- K140546Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine TestHealgen Scientific,, LLC · 2014 · cites it directly4descendants
- K150096Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test…Healgen Scientific,, LLC · 2015 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K050186 | Ameditech Immutest Multi-Drug Screen Panel Iii | Ameditech, Inc. | 2005 | 3 |
| 0 (this device) | K052115 | First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine… | First Check Diagnostics, LLC | 2005 | — |
| +1 | K143187 | Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone… | Healgen Scientific,, LLC | 2015 | — |
| +1 | K142280 | Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test… | Healgen Scientific,, LLC | 2014 | — |
| +1 | K141647 | Healgen Coc One Step Cocaine Test Strip:Morhpine Test Strip (Cassette, Cup… | Healgen Scientific,, LLC | 2014 | — |
| +1 | K140546 | Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine Test | Healgen Scientific,, LLC | 2014 | 2 |
| +1 | K150096 | Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen… | Healgen Scientific,, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 5 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DKZ device
- #1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050186 | Ameditech Immutest Multi-Drug Screen Panel IiiSummary page 2…or multi-drug display and the Accu-Stat Drugs of Abuse Home Test Cup. The analytical studies of the identical Ameditech, Inc ImmuTest Drug Screen Cup (K050186) indicate that the drug test reacts specifically with the above listed drugs and their metabolites. A consumer study usi… | 2005 |
| * | — | Accu-Stat Home Drug Test Cup Named without a submission number | |
| * | — | First Check Home Drug Tests Named without a submission number | |
| * | — | First Check Home Drug Test Kit Named without a submission number | |
| * | — | Phamatech At Home Drug Test Cup Named without a submission number |
What descends from it? (18)
See all 1813 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143187 | Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test… | 2015 | 4 |
| K142280 | Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip… | 2014 | 4 |
| K141647 | Healgen Coc One Step Cocaine Test Strip:Morhpine Test Strip (Cassette, Cup, Dip Card) | 2014 | 4 |
| K140546 | Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine Test | 2014 | 4 |
| K150096 | Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test… | 2015 | 3 |
| K153646 | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test… | 2016 | 1 |
| K161251 | CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests | 2016 | 0 |
| K153741 | CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test | 2016 | 0 |
| K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test | 2015 | 0 |
| K151211 | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech… | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 18, 2020 | Class II | Z-3031-2020 | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
| Aug 18, 2020 | Class II | Z-3048-2020 | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
| Aug 18, 2020 | Class II | Z-3050-2020 | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
| Aug 18, 2020 | Class II | Z-3042-2020 | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
| Aug 18, 2020 | Class II | Z-3046-2020 | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
| Aug 18, 2020 | Class II | Z-3049-2020 | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
| Aug 18, 2020 | Class II | Z-3036-2020 | Process control | Various immunoassay enzymes failed product performance, thereby the products do not consistently detect all calibrator and secondary compounds at the levels stated in the labeling. |
| Nov 16, 2015 | Class III | Z-0518-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0542-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0514-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0534-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0512-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0487-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0511-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0486-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0517-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0521-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0532-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0527-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0520-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0494-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0529-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0536-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0505-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0485-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0500-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0504-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0493-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0516-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0497-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0522-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0484-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0524-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0498-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0515-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0523-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0519-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0525-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0541-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0489-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0528-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0499-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0530-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0496-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0506-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0502-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0491-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0492-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0490-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
| Nov 16, 2015 | Class III | Z-0495-2016 | Nonconforming Material/Component | Ameditechs Drugs of Abuse Tests listed above have shown reduced reactivity for up to two (2) of the nineteen (19) Benzodiazepine (BZO) compounds for which specificity information is provided in the product insert. The particular BZO… |
The 5 latest of 50 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DKZ
1in 2024
2007high 8 (2013) · low 0 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · DKZ
180in 2019
2007high 233 (2010) · low 55 (2012)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DKZ
1in 2017
2007high 5 (2009) · low 0 (2010)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKZ
2in 2025
2007high 12 (2008) · low 0 (2007)2025
MAUDE reports naming product code DKZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 2 | — | 3 | 12 |
| 2009 | 2 | — | 5 | 1 |
| 2010 | 4 | 233 | 0 | 1 |
| 2011 | 6 | 123 | 4 | 2 |
| 2012 | 5 | 55 | 0 | 0 |
| 2013 | 8 | 103 | 1 | 1 |
| 2014 | 8 | 128 | 3 | 9 |
| 2015 | 5 | 107 | 0 | 8 |
| 2016 | 5 | 215 | 0 | 8 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 3 | 128 | 0 | 0 |
| 2019 | 3 | 180 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The First Check® Multi Drug Cup 12 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI), Phencyclidine (PCP), Benzodiazepine (BZO), Barbiturates (BAR), Methadone (MTD), Tri-cyclic Antidepressants (TCA) and Oxycodone (OXY) is a screening test for the rapid detection of the twelve drugs listed above in human urine. The designated cut-off concentrations of these drugs are as follows: Marijuana at 50…
Read the full statement (324 words)
The First Check® Multi Drug Cup 12 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI), Phencyclidine (PCP), Benzodiazepine (BZO), Barbiturates (BAR), Methadone (MTD), Tri-cyclic Antidepressants (TCA) and Oxycodone (OXY) is a screening test for the rapid detection of the twelve drugs listed above in human urine. The designated cut-off concentrations of these drugs are as follows: Marijuana at 50 ng/mL, Cocaine at 300 ng/mL, Amphetamine at 1000 ng/mL, Methamphetamine at I000 ng/mL, Ecstasy at 500 ng/mL, Opiates at 2000 ng/mL, Phencyclidine at 25 ng/mL, Benzodiazepine at 300 ng/mL, Barbiturates at 300 ng/mL, Methadone at 300 ng/mL, Tri-cyclic Antidepressants at 1,000 ng/mL and Oxycodone at 100 ng/mL.
The BAR, BZO, TCA, OXY assay will yield preliminary positive results when BAR, BZO, TCA and OXY is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressant and oxycodone in urine. The Multi Drug Cup 12 shows the drug was or was not present at the cutoff level.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method for most drugs (HPLC is the preferred confirmatory method for Tri-cyclic Antidepressants). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
This device is not intended for workplace testing. This device is intended for Home Use.
The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing - the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052115: First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp), Methamphetamine (Met), Ecstasy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052115
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026