# K972577: Quick Screen One Step Amphetamine Test

- Pathway: 510(k) (Traditional)
- Applicant: Phamatech
- Decided: Aug 20, 1997 after 41 days
- Product code: DIT (Thin Layer Chromatography, 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) ABI SureStep: named in the summary without a submission number
- (no number) Syntron Bioresearch Amphetamine Test: named in the summary without a submission number

## Indications for use
A drug of abuse assay intended for use in clinical toxicology laboratories, physicians’ offices, drug-of-abuse clinics and taw enforcement agencies is an in-vitro diagnostic test for the qualitative identification of amphetamine, a central nervous system stimulating drug, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of amphetamine use and overdose.

Source page: https://510kreport.com/device/K972577
Methodology: https://510kreport.com/methodology