# K113046: Ameditech Immutest Milti-Drug Screen - Pathway: 510(k) (Special) - Applicant: Ameditech, Inc. - Decided: Nov 10, 2011 after 28 days - Product code: DKZ (Enzyme Immunoassay, Amphetamine) - Device class: 2 - Regulation: 21 CFR 862.3100 - Recalls of this device: 84 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 1 generation back to K040092 (2004). 4 ancestors in all. 1 later device descends from it; 1 cites it directly. 0 of 6 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K050186: Ameditech Immutest Multi-Drug Screen Panel Iii, Ameditech, Inc. (2005) Summary page 1. - K040092: Ameditech Immu Test Drug Screen Panel, Ameditech, Inc. (2004) Summary page 2. - K042975: Ameditech Immutest Multi-Drug Screen Panel II, Ameditech, Inc. (2004) Summary page 2. - K063015: Ameditech Immutest Multi-Drug Screen Bup/PPX/COC150, Ameditech, Inc. (2006) Summary page 2. ## Most influential descendants - K113501: Ameditech Checkcup Multi Drug Test (Flat/Round Cup) (2011), 0 descendants of its own ## 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. - Aug 18, 2020 · Class II · Z-3042-2020: 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. - Aug 18, 2020 · Class II · Z-3036-2020: 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 - 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-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-0504-2016: 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 ## Indications for use The ImmuTest Multi-Drug Screen 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 SUPD Buprenorphine 10 BZO Oxazepam 300 COC 150 Benzoylecgonine 150 CCC Benzoylecgonine 300 MVDMA 3,4-methylenedioxymethamphetamine *500 MET 500 d-Methamphetamine 500 MET d-Methamphetamine 1000 MTD dI-Methadone 300 OPI 300 Morphine 300 OPI Morphine 2000 OXY Oxycodone 100 PCP Phencyclidline 25 PPX Propoxyphene 300 TCA Nortriptyline 1000 THC 11-nor-A9-THC-9-COOH 50 The ImmuTest Multi-Drug Screen consists of three test formats: card, cassette and cup. The configurations of the ImmuTest Multi-Drug Screen consist of any combination of the drugs listed above. The ImmuTest Multi-Drug Screen 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/fWS) and Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmation methods. Source page: https://510kreport.com/device/K113046 Methodology: https://510kreport.com/methodology