# K994404: Instant-View Morphine Urine Cassette Test

- Pathway: 510(k) (Traditional)
- Applicant: Alfa Scientific Designs, Inc.
- Decided: Jul 5, 2000 after 190 days
- Product code: DPK (Liquid Chromatography, Morphine)
- Device class: 2
- Regulation: 21 CFR 862.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K972571 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972571: Quikstrip One Step Opiates Test, Drial Consultants, Inc. (1997) Summary page 1.

## Indications for use
Instant-View Morphine Urine Cassette Test is a qualitative one step lateral flow, competitive binding immunoassay device intended to be used to detect morphine only in human urine at a cutoff level of 300 ng/ml. It is intended for health care professional use only. The US Substance Abuse and Mental Health Services Administration (SAMHSA) recommends the screening levels for Morphine to be at a concentration of 2000 ng/ml. This Test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K994404
Methodology: https://510kreport.com/methodology