# K052197: First Sign Drug of Abuse Urine Screening Test

- Pathway: 510(k) (Traditional)
- Applicant: W.H.P.M., Inc.
- Decided: Jun 9, 2006 after 301 days
- Product code: DJR (Enzyme Immunoassay, Methadone)
- Device class: 2
- Regulation: 21 CFR 862.3620
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K991079 (1999). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012300: Acon Bzo One Step Benzodiazepines Test Strip; Acon Bzo One Step Benzodiazepines Test Device, ACON Laboratories, Inc. (2001) Summary page 1.
- K043507: Acon Oxy II One Step Oxycodone Test Strip; Test Device, ACON Laboratories, Inc. (2005) Summary page 1.
- K050593: Acon Bar II One Step Barbiturates Test Strip & Device, ACON Laboratories, Inc. (2005) Summary page 1.
- K012595: Acon MTD One Step Methadone Test Strip and Test Device, ACON Laboratories, Inc. (2001) Summary page 1.
- K021526: Acon Tca One Step Tricyclic Antidepressant Test Strip and Device, ACON Laboratories, Inc. (2002) Summary page 1.
- K022589: Acon Mdma One Step Ecstasy Test Strip & Acon Mdma One Step Ecstasy Test Device, ACON Laboratories, Inc. (2002) Summary page 1.

## Indications for use
The First Sign Drug of Abuse Tests are rapid, chromatographic immunoassays for the qualitative detection of drugs-of-abuse in human urine. The tests may be run singly of in combinations of up to six drugs simultaneously. The cut-off concentrations and specific analytes tested for are listed below. This assay provides only a preliminary test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment must be applied to any drug of abuse test result, particularly when preliminary positive results are obtained. For Professional Use Only. First Sign Nortriptyline — nortriptyline — 1,000ng/mL First Sign Secobarbital — secobarbital — 300ng/mL First Sign MDMA — mdma — 5OOng/mL First Sign Oxazepam — oxazepam — 300ng/mL First Sign Oxycodone — oxycodone — I OOng/mL First Sign Methadone — methadone — 300ng/mL

Source page: https://510kreport.com/device/K052197
Methodology: https://510kreport.com/methodology