# K100051: Instant-View Milti-Drug of Abuse Urine Test (Panel, Cup), Instant-Verdict Multi-Drug of Abuse Urine Test (Panel, Cup)

- Pathway: 510(k) (Abbreviated)
- Applicant: Alfa Scientific Designs, Inc.
- Decided: Jul 6, 2010 after 179 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: 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 1.
- 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 1.

## Indications for use
The Drug of Abuse Urine (Cassette/Cup) Test is a rapid qualitative immunoassay for the detection of potential abuse of one or more drugs: Morphine/Opiates, and Oxycodone (see list below). The device is intended for in vitro diagnostic home use. Abbreviation Test Calibrator Cutoff MORIOP1300 Morphine/Opiates Morphine 309 ng/mL OXY100 Oxycodone Oxycodone 100 ng/inL OXY300 Oxycodone Oxycodone 300 ng/mL This assay provides only* preliminary results. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography/mass spectrometry (LC/MS) 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 indicated.

Source page: https://510kreport.com/device/K100051
Methodology: https://510kreport.com/methodology