# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Scientific Designs, Inc.
- Decided: Feb 23, 2018 after 128 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: 6 generations back to K001178 (2000). 16 ancestors in all.
12 later devices descend from it; 3 cite 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)
- K152122: Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use), Alfa Scientific Designs, Inc. (2016) Summary page 8.

## Most influential descendants
- 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
- K250727: AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test Cup (2025), 1 descendant of its own

## Indications for use
The INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) device is a rapid, qualitative immunoassay device for the detection of one or more drugs or metabolites at the designated cutoff concentrations in human urine. The device can detect up to 13 drugs or their metabolites: Analyte Calibrator Cutoff (ng/mL) Amphetamines d-Amphetamine 1000 Barbiturates Secobarbital 200 Buprenorphine Buprenorphine 10 Benzodiazepines Oxazepam 300 Cocaine Benzoylecgonine 300 Methamphetamine d-Methamphetamine 1000 Methadone Methadone 300 Phencyclidine Phencyclidine 25 Tricyclic Antidepressants Nortriptyline 1000 Cannabinoids 11-nor-A9-THC-9-COOH 50 MDMA Methylenedioxymethamphetamine 500 Morphine Morphine 2000 Oxycodone Oxycodone 300 These assays may yield positive results when barbiturates, benzodiazepines, or tricyclic antidepressants are ingested at or above therapeutic doses. There are no uniformly recognized cutoff levels for barbiturates, benzodiazepines, or tricyclic antidepressants in urine. The assays are not intended to distinguish between prescription use or abuse of these drugs. This device provides 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. The INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) device is a rapid, qualitative immunoassay device for the detection of one or more drugs or metabolites at the designated cutoff concentrations in human urine. The device can detect up to 13 drugs or their metabolites: Analyte Amphetamines Barbiturates Buprenorphine Benzodiazepines Cocaine Methamphetamine Methadone Phencyclidine Tricyclic Antidepressants Cannabinoids MDMA Morphine Oxycodone Calibrator d-Amphetamine Secobarbital Buprenorphine Oxazepam Benzoylecgonine d-Methamphetamine Methadone Phencyclidine Nortriptyline 11-nor-A9-THC-9-COOH Cutoff (ng/mL) 1000 200 10 300 300 1000 300 25 1000 50 Methylenedioxymethamphetamine 500 Morphine Oxycodone 2000 300 These assays may yield positive results when barbiturates, benzodiazepines, or tricyclic antidepressants are ingested at or above therapeutic doses. There are no uniformly recognized cutoff levels for barbiturates, benzodiazepines, or tricyclic antidepressants in urine. The assays are not intended to distinguish between prescription use or abuse of these drugs. This device provides 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.

Source page: https://510kreport.com/device/K173303
Methodology: https://510kreport.com/methodology