# K113501: Ameditech Checkcup Multi Drug Test (Flat/Round Cup) - Pathway: 510(k) (Special) - Applicant: Ameditech, Inc. - Decided: Dec 5, 2011 after 10 days - Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites) - Device class: 2 - Regulation: 21 CFR 862.3250 - Recalls of this device: 79 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 2 generations back to K040092 (2004). 6 ancestors in all. No later device cites it as a predicate yet. 0 of 7 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K053175: Ameditech Drugsmartcup, Ameditech, Inc. (2005) Summary page 3. - K113046: Ameditech Immutest Milti-Drug Screen, Ameditech, Inc. (2011) Summary page 3. ## Recalls of this device - Aug 18, 2020 · Class II · Z-3051-2020: 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: 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 pr - Nov 16, 2015 · Class III · Z-0515-2016: 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 pr - Nov 16, 2015 · Class III · Z-0530-2016: 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 pr - Nov 16, 2015 · Class III · Z-0522-2016: 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 pr - Nov 16, 2015 · Class III · Z-0542-2016: 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 pr - Nov 16, 2015 · Class III · Z-0541-2016: 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 pr - Nov 16, 2015 · Class III · Z-0521-2016: 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 pr - Nov 16, 2015 · Class III · Z-0505-2016: 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 pr - Nov 16, 2015 · Class III · Z-0490-2016: 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 pr - Nov 16, 2015 · Class III · Z-0492-2016: 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 pr - Nov 16, 2015 · Class III · Z-0516-2016: 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 pr - Nov 16, 2015 · Class III · Z-0487-2016: 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 pr - Nov 16, 2015 · Class III · Z-0524-2016: 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 pr - Nov 16, 2015 · Class III · Z-0486-2016: 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 pr - Nov 16, 2015 · Class III · Z-0519-2016: 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 pr - Nov 16, 2015 · Class III · Z-0489-2016: 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 pr - Nov 16, 2015 · Class III · Z-0528-2016: 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 pr - Nov 16, 2015 · Class III · Z-0532-2016: 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 pr - Nov 16, 2015 · Class III · Z-0485-2016: 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 pr - Nov 16, 2015 · Class III · Z-0506-2016: 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 pr - Nov 16, 2015 · Class III · Z-0491-2016: 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 pr - Nov 16, 2015 · Class III · Z-0507-2016: 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 pr - Nov 16, 2015 · Class III · Z-0501-2016: 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 pr - Nov 16, 2015 · Class III · Z-0495-2016: 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 pr - Nov 16, 2015 · Class III · Z-0509-2016: 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 pr - Nov 16, 2015 · Class III · Z-0512-2016: 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 pr - Nov 16, 2015 · Class III · Z-0493-2016: 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 pr - Nov 16, 2015 · Class III · Z-0518-2016: 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 pr - Nov 16, 2015 · Class III · Z-0497-2016: 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 pr - Nov 16, 2015 · Class III · Z-0511-2016: 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 pr - Nov 16, 2015 · Class III · Z-0484-2016: 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 pr - Nov 16, 2015 · Class III · Z-0514-2016: 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 pr - Nov 16, 2015 · Class III · Z-0498-2016: 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 pr - Nov 16, 2015 · Class III · Z-0517-2016: 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 pr - Nov 16, 2015 · Class III · Z-0523-2016: 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 pr - Nov 16, 2015 · Class III · Z-0534-2016: 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 pr - Nov 16, 2015 · Class III · Z-0525-2016: 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 pr - Nov 16, 2015 · Class III · Z-0527-2016: 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 pr - Nov 16, 2015 · Class III · Z-0494-2016: 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 pr - Nov 16, 2015 · Class III · Z-0529-2016: 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 pr - Nov 16, 2015 · Class III · Z-0499-2016: 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 pr - Nov 16, 2015 · Class III · Z-0536-2016: 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 pr - Nov 16, 2015 · Class III · Z-0488-2016: 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 pr - Nov 16, 2015 · Class III · Z-0503-2016: 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 pr - Nov 16, 2015 · Class III · Z-0510-2016: 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 pr - Nov 16, 2015 · Class III · Z-0508-2016: 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 pr - Nov 16, 2015 · Class III · Z-0520-2016: 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 pr - Nov 16, 2015 · Class III · Z-0502-2016: 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 pr - Nov 16, 2015 · Class III · Z-0500-2016: 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 pr ## Indications for use 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. Source page: https://510kreport.com/device/K113501 Methodology: https://510kreport.com/methodology