# K052115: First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp), Methamphetamine (Met), Ecstasy - Pathway: 510(k) (Traditional) - Applicant: First Check Diagnostics, LLC - Decided: Dec 29, 2005 after 147 days - Product code: DKZ (Enzyme Immunoassay, Amphetamine) - Device class: 2 - Regulation: 21 CFR 862.3100 - Recalls of this device: 86 (0 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 1 generation back to K050186 (2005). 1 ancestor in all. 18 later devices descend from it; 13 cite it directly. 0 of 20 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 2. - (no number) Accu-Stat Home Drug Test Cup: named in the summary without a submission number - (no number) First Check Home Drug Tests: named in the summary without a submission number - (no number) First Check Home Drug Test Kit: named in the summary without a submission number - (no number) Phamatech At Home Drug Test Cup: named in the summary without a submission number ## Most influential descendants - K143187: Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Oxycodone Test (Strip, Cassette, Cup, Dip Card) (2015), 4 descendants of its own - K142280: Healgen Oxazepam Test (Strip, Cassette, Cup, Dip Card), Healgen Morphine Test (Strip, Cassette, Cup, Dip Card) (2014), 4 descendants of its own - K141647: Healgen Coc One Step Cocaine Test Strip:Morhpine Test Strip (Cassette, Cup, Dip Card) (2014), 4 descendants of its own - K140546: Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine Test (2014), 4 descendants of its own - K150096: Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) (2015), 3 descendants of its own ## Recalls of this device - Aug 18, 2020 · Class II · Z-3031-2020: 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-3048-2020: 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-3050-2020: 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-3046-2020: 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-3049-2020: 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 ## Indications for use 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. Source page: https://510kreport.com/device/K052115 Methodology: https://510kreport.com/methodology