# K973726: Fingerprint Drug Screening Device

- Pathway: 510(k) (Traditional)
- Applicant: Applied Technology Ventures, LLC
- Decided: Nov 6, 1997 after 37 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The FINGERPRINT Drug Screening Device™ is a professional use, rapid, multiple immunoassay test for the qualitative determination of the major metabolites of the following drugs of abuse in human urine at the National Institute on Drug Abuse (NIDA) specified cutoff concentrations. AMP amphetamines 1000 ng/ml COC cocaine 300 ng/ml MOR opiates 300 ng/ml PCP phencyclidine 25 ng/ml THC cannabinoids 50 ng/ml FINGERPRINT Drug Screening Device™ 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 spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K973726
Methodology: https://510kreport.com/methodology