# K152122: Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Scientific Designs, Inc.
- Decided: Jun 24, 2016 after 330 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.
13 later devices descend from it; 1 cites it directly.
0 of 29 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 5.

## Most influential descendants
- 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
- K241428: AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup (2024), 2 descendants of its own

## Indications for use
The Instant-View® Multi-Drug Urine Test Cup (Home Use) and Instant-View® Multi-Drug Urine Test Panel (Home Use) are rapid, qualitative immunoassays for the detection in human urine of one or more of the drugs at the cutoff concentrations listed below. These devices will detect up to 13 of the drugs below in any combination. The tests are not intended to distinguish prescription use or abuse of any drugs. Abbreviation Test Calibrator Cut-off (ng/ml) AMP Amphetamine d-Amphetamine 1000 BAR Barbiturates Secobarbital 200 BUP Buprenorphine Buprenorphine 10 BZD Benzodiazepine Oxazepam 300 COC Cocaine Benzoylecgonine 300 MDMA MDMA or Ecstasy Methylenedioxy-methamphetamine 500 MET Methamphetamine d-Methamphetamine 1000 MTD Methadone Methadone 300 MOR Morphine/Opiate Morphine 2000 OXY Oxycodone Oxycodone 300 PCP Phencyclidine Phencyclidine 25 TCA Tricyclic Antidepressants Nortriptyline 1000 THC Marijuana 1 1-nor-A9-THC-9-COOH 50 These devices provide only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry 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. 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. Tests for prescription drugs will yield preliminary positive results when these drugs are ingested at or above therapeutic doses. There are no uniformly recognized drug levels for prescription drugs in urine. This multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level.

Source page: https://510kreport.com/device/K152122
Methodology: https://510kreport.com/methodology