# K063545: Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test (Cassette, Dip-Strip), Cocaine, Methamphetamine - Pathway: 510(k) (Abbreviated) - Applicant: Alfa Scientific Designs, Inc. - Decided: May 7, 2007 after 164 days - Product code: DJG (Enzyme Immunoassay, Opiates) - Device class: 2 - Regulation: 21 CFR 862.3650 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 4 generations back to K001178 (2000). 14 ancestors in all. 16 later devices descend from it; 3 cite it directly. 0 of 31 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K994395: Instant-View Amphetamine Urine Cassette Test, Alfa Scientific Designs, Inc. (2000) Summary page 1. - K994403: Instant-View Cocaine (Benzylecgonine) Urine Dip Strip Test, Alfa Scientific Designs, Inc. (2000) Summary page 3. - K003845: Modification to Instant-View Methamphetamine (Meth 1000) Urine Test (Dip Strip), Alfa Scientific Designs, Inc. (2001) Summary page 5. - K033047: Acon Oxy One Step Oxycodone Test Strip and Acon Oxy One Step Oxycodone Test Device, ACON Laboratories, Inc. (2004) Summary page 7. - K022564: Instant-View Multi-Drug Screen Urine Test, Alfa Scientific Designs, Inc. (2002) Summary page 12. - K022915: Instant-View Propoxyphene (PPX) Urine Test, Alfa Scientific Designs, Inc. (2002) Summary page 12. - K022693: Instant-View Tca Urine Test, Alfa Scientific Designs, Inc. (2002) Summary page 12. - K022501: Instant-View Mdma (Ecstasy, XTC) Urine Test, Alfa Scientific Designs, Inc. (2002) Summary page 12. - K060527: Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test; Instant-Confirmatory Bup/Nbup Urine Test, Alfa Scientific Designs, Inc. (2006) Summary page 12. ## Most influential descendants - K152122: Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) (2016), 13 descendants of its own - K173303: INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) (2018), 12 descendants of its own - K182738: Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) (2019), 9 descendants of its own - K233019: AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx (2023), 8 descendants of its own - K244043: AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup (2025), 4 descendants of its own ## Indications for use The Amphetamine (300) test is a qualitative immunoassay for the rapid detection of amphetamine from human urine specimens at a cutoff concentration of 300 ng/ml. It is for health care professional use only. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) 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 obtained. The Cocaine (150) test device is a rapid qualitative immunoassay for the rapid detection of cocaine (benzoylecgonine) from human urine specimens at a cutoff concentration of 150 ng/ml. It is for health care professional use only. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) 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 obtained. The Methamphetamine (300) test is a qualitative immunoassay for the rapid detection of methamphetamine from human urine specimens at a cutoff concentration of 300 ng/ml. It is for health care professional use only. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) 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 obtained. The Oxycodone (100) test is a qualitative immunoassay for the rapid detection of oxycodone from human urine specimens at a cutoff concentration of 100 ng/ml. It is for health care professional use only. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) 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 obtained. The Oxycodone (300) test is a qualitative immunoassay for the rapid detection of oxycodone from human urine specimens at a cutoff concentration of 300 ng/ml. It is for health care professional use only. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) 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 obtained. The multi-drug of abuse device is a rapid qualitative immunoassay for screening potential abuse of one or more drugs listed below. The device detects any combination of the drugs or drug metabolites at or above the specified cut-off levels. It is for health care professional use. Abbreviation Test Cutoff AMP Amphetamine 1000 ng/ml AMP300 Amphetamine 300 ng/ml BAR Blarbiturates 200 ng/ml BUP Buprenorphine/Norbuprenorphine 10 ng/ml BZD Benzodiazepine 300 ng/ml COC Cocaine 300 ng/ml COC150 Cocaine 150 ng/ml MET Methamphetamine 1000 ng/ml MET500 Methamphetarmne 500 ng/ml MET300 Methamphetamine 300 ng/ml MOR Morphine 2000 ng/ml MOR300 Morphine 300 ng/ml MTD Methadone 300 ng/ml OXY100 Oxycodone 100 ng/ml 0XY300 Oxycodone 300 ng/ml PCP Phencyclidine 25 nglml PPX Propoxyphene 300 ng/mir TCA Tricyclics 1000 ng/mld THZC Marijuana 50 ng/nilbo XTC MDMA or Ecstasy 500 ng/mI The BAR, BZD, TCA test will yield preliminary positive results when BA4R, BZD, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressant in urine, The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result, Gas Chromatography/Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) 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 obtained. The multi-drug of abuse device is a rapid qualitative immunoassay for screening potential abuse of one or more drugs listed below. The device detects any combination of the drugs or drug metabolites at or above the specified cut-off levels. Abbreviation Test Cutoff AMP Amphetamine 1000 ng/ml BAR Barbiturates 200 ng/ml BZD Benzodiazepine 300 ng/ml COC Cocaine 300 ng/ml MET Methamphetamine 1000 ng/ml MOR Morphine 2000 ng/ml MTD Methadone 300 ng/ml PCP Phencyclidine 25 ng/ml TCA Tricyclics 1000 ng/ml THC Marijuana 50 ng/ml XTC MDMA or Ecstasy 500 ng/ml This 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, is provided in the package labeling. The BAR, BZD, TCA test will yield preliminary positive results when BAR, BZD, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) 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 obtained. Source page: https://510kreport.com/device/K063545 Methodology: https://510kreport.com/methodology