510(k) · Cleared
Recalled · Class II · 2020Ameditech Checkcup Multi Drug Test (Flat/Round Cup)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ameditech, Inc. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on Dec 5, 2011 as substantially equivalent to K053175 (Ameditech, Inc., 2005) and 1 other predicate after a 10-day review. Its family tree reaches back 2 generations to 2004. It has been recalled 79 times.
- Decided
- Dec 5, 2011
- Review
- 10 days
- Class
- Class II
- Product code
- DIO
- Recalls
- 79
- Predicates
- 2
Its longest line of descent runs back 2 generations to K040092 (2004). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K040092 | Ameditech Immu Test Drug Screen Panel | Ameditech, Inc. | 2004 | — |
| −1 | K113046 | Ameditech Immutest Milti-Drug Screen | Ameditech, Inc. | 2011 | 84 |
| 0 (this device) | K113501 | Ameditech Checkcup Multi Drug Test (Flat/Round Cup) | Ameditech, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 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 DIO? 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 DIO device
- #1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.1 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K053175 | Ameditech DrugsmartcupSummary page 3…510(k) Summary Comparison with the Predicate The modified device isidentical to the cleared predicate referenced above (K053175). The drug strips cleared by FDA in submission K113046 will be placed in round cup that was cleared in K053175. In addition, the… | 2005 |
| * | K113046 | Ameditech Immutest Milti-Drug ScreenSummary page 3…Summary Comparison with the Predicate The modified device isidentical to the cleared predicate referenced above (K053175). The drug strips cleared by FDA in submission K113046 will be placed in round cup that was cleared in K053175. In addition, the drug strips will be placed in a new format (flat cup).… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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-3051-2020 | 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-0507-2016 | 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-0501-2016 | 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… |
| Nov 16, 2015 | Class III | Z-0509-2016 | 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-0488-2016 | 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-0503-2016 | 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-0510-2016 | 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-0508-2016 | 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-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-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… |
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?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 7.7 years on median.
- 5 of the 6 ancestors have a recall of any class.
How does its category compare?
All DIO devicesDIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DIO
1in 2022
2007high 5 (2011) · low 0 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · DIO
267in 2017
2007high 267 (2017) · low 65 (2011)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIO
1in 2013
2007high 1 (2013) · low 0 (2007)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIO
1in 2023
2007high 22 (2019) · low 0 (2007)2025
MAUDE reports naming product code DIO, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 5 | 65 | 0 | 4 |
| 2012 | 5 | 139 | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 3 | 88 | 0 | 9 |
| 2017 | 3 | 267 | 0 | 16 |
| 2018 | 1 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 22 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CHECKCUP Multi-Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at the following cutoff concentrations: Test | Calibrator | Cut-off (ng/ml) AMP | d-Amphetamine | 1000 BAR | Secobarbital | 300 BUP | Buprenorphine | 10 BZO | Oxazepam | 300 COC 150 | Benzoylecgonine | 150 COC | Benzoylecgonine | 300 MOMA | 3,4-methylenedioxymethamphetamine | 500 MET 500 | d-Methamphetamine | 500 MET…
Read the full statement (226 words)
The CHECKCUP Multi-Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at the following cutoff concentrations:
Test | Calibrator | Cut-off (ng/ml)
AMP | d-Amphetamine | 1000
BAR | Secobarbital | 300
BUP | Buprenorphine | 10
BZO | Oxazepam | 300
COC 150 | Benzoylecgonine | 150
COC | Benzoylecgonine | 300
MOMA | 3,4-methylenedioxymethamphetamine | 500
MET 500 | d-Methamphetamine | 500
MET | d-Methamphetamine | 1000
MTD | dl-Methadone | 300
OPI 300 | Morphine | 300
OPI | Morphine | 2000
OXY | Oxycodone | 100
PCP | Phencyclidine | 25
PPX | Propoxyphene | 300
TCA | Nortriptyline | 100
THC | 11-nor-A9-THC-9-COOH | 50
The CHECKCUP Multi-Drug Test consists of two test formats: flat cup and round cup. The configurations of the CHECKCUP Multi-Drug Test consist of any combination of the drugs listed above. The CHECKCUP is used to obtain a visual, qualitative result and is intended for professional use only.
This assay provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmation methods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113501 · printed Nov 4, 2026
Cite this page
510(k) Report. “K113501: Ameditech Checkcup Multi Drug Test (Flat/Round Cup).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K113501
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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