# K032575: First Sign Drug of Abuse Screening Test

- Pathway: 510(k) (Traditional)
- Applicant: W.H.P.M., Inc.
- Decided: May 19, 2004 after 273 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Acon Rapid Drug Screens: named in the summary without a submission number

## Indications for use
First SignTM Drugs of Abuse Screening Test are one-step lateral flow immunoassays intended for the detection of drug analytes in urine. First SignTM Drug of Abuse Screening Test are intended for use in the qualitative detection of drugs of abuse at the following Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels: Compound — Abbreviation — Level Amphetamine (d-amphetamine sulfate) — AMP — 1000 ng/ml Methamphetamine ((+)methamphetamine HC 1) — METH — 1000 ng/ml Opiates 2000 (morphine-3-P-D glucuronide) — OPI — 2000 ng/ml Opiates 300 (morphine-3-P-D glucuronide) — OPI — 300 ng/ml Cocaine (Benzoylecgonine) — COC — 300 ng/ml Cannabinoids (11-nor-A9-THC-9-carboxylic-acid) — THC — 50 nghnl Phencyclidine (phencyclidine HCI) — PCP — ml First SignTM Drugs of Abuse Screening Test provide only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained.

Source page: https://510kreport.com/device/K032575
Methodology: https://510kreport.com/methodology