510(k) · Cleared
ClearedFirst Check Multi Drug Cup 7 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
Worldwide Medical, LLC · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Sep 7, 2005 as substantially equivalent to K040092 (Ameditech, Inc., 2004) and 1 other predicate after a 49-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Sep 7, 2005
- Review
- 49 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K040092 (2004). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK040092 Ameditech Immu Test Drug Screen PanelAmeditech, Inc. · 2004
- This deviceK051966 First Check Multi Drug Cup 7 for Marijuana (THC), Cocaine (Coc)…Worldwide Medical, LLC · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040092 | Ameditech Immu Test Drug Screen Panel | Ameditech, Inc. | 2004 | — |
| 0 (this device) | K051966 | First Check Multi Drug Cup 7 for Marijuana (THC), Cocaine (Coc), Amphetamine… | Worldwide Medical, LLC | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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? (4)
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 |
|---|---|---|---|
| * | K040092 | Ameditech Immu Test Drug Screen PanelSummary page 2…ngle 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 (K040092 and K042975) indicate that the drug test reacts specifically with the above listed drugs and their metabolites. A consumer… | 2004 |
| * | K042975 | Ameditech Immutest Multi-Drug Screen Panel IISummary page 2…i-drug display and the Accu-Stat Drugs of Abuse Home Test Cup. The analytical studies of the identical Ameditech, Inc ImmuTest Drug Screen Cup (K040092 and K042975) indicate that the drug test reacts specifically with the above listed drugs and their metabolites. A consumer study using… | 2004 |
| * | — | Accu-Stat Home Drug Test Cup Named without a submission number | |
| * | — | First Check Home Drug Tests Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K040092.
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
2026 to Oct 25, outlined.
Median 510(k) review, days · DKZ
180in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DKZ
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKZ
2in 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 7 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI) and Phencyclidine (PCP) is a screening test for the rapid detection of one to seven of the above listed drugs in a variety of combinations 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…
Read the full statement (216 words)
The First Check® Multi Drug Cup 7 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI) and Phencyclidine (PCP) is a screening test for the rapid detection of one to seven of the above listed drugs in a variety of combinations 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, and Phencyclidine at 25 ng/ml.
This device 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. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
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/K051966 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051966: First Check Multi Drug Cup 7 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/K051966
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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