# K131645: Instant-View Multi-Drug of Abuse Urine Test (Cup, Panel Cassette)

- Pathway: 510(k) (Abbreviated)
- Applicant: Alfa Scientific Designs, Inc.
- Decided: Oct 7, 2013 after 124 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K001178 (2000). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063545: Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test (Cassette, Dip-Strip), Cocaine, Methamphetamine, Alfa Scientific Designs, Inc. (2007) Summary page 2.

## Indications for use
The Instant-View Multi-Drug of Abuse Urine Test Cup is a rapid, qualitative immunoassay for the detection of one or more of the following drugs in human urine. This device is for over the counter use and may detect any combination of the drugs or drug metabolites at or above the specified cut-off level listed below. Abbreviation — Test — Cutoff AMP — Amphetamine — 1000 ng/mL BAR — Barbiturates — 200 ng/mL BZD — Benzodiazepine — 300 ng/mL COC — Cocaine — 300 ng/mL MDMA — MDMA or Ecstasy — 500 ng/mL MET — Methamphetamine — 1000 ng/mL MTD — Methadone — 300 ng/mL MOR — Morphine/Opiates — 2000 ng/mL OXY — Oxycodone — 100 ng/mL PCP — Phencyclidine — 25 ng/mL TCA — Tricyclic antidepressants — 1000 ng/mL THC — Marijuana — 50 ng/mL The drug tests will provide a preliminary result only. A more specific, alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and High-Performance Liquid Chromatography (HPLC), or the like, are the preferred confirmation methods for most drugs in urine. Clinical consideration and professional judgment should be applied to any drug test result, particularly when evaluating preliminary positive results. The Instant-View Multi-Drug of Abuse Urine Test Panel is a rapid, qualitative immunoassay for the detection of one or more of the following drugs in human urine. This device is for over the counter use and may detect any combination of the drugs or drug metabolites at or above the specified cut-off level listed below. Abbreviation — Test — Cutoff AMP — Amphetamine — 1000 ng/mL BAR — Barbiturates — 200 ng/mL BZD — Benzodiazepine — 300 ng/mL COC — Cocaine — 300 ng/mL MDMA — MDMA or Ecstasy — 500 ng/mL MET — Methamphetamine — 1000 ng/mL MTD — Methadone — 300 ng/mL MOR — Morphine/Opiates — 300 ng/mL OXY — Oxycodone — 100 ng/mL PCP — Phencyclidine — 25 ng/mL TCA — Tricyclic antidepressants — 1000 ng/mL THC — Marijuana — 50 ng/mL The drug tests will provide a preliminary result only. A more specific, alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and High-Performance Liquid Chromatography (HPLC), or the like, are the preferred confirmation methods for most drugs in urine. Clinical consideration and professional judgment should be applied to any drug test result, particularly when evaluating preliminary positive results.

Source page: https://510kreport.com/device/K131645
Methodology: https://510kreport.com/methodology