# K972618: Quickscreen One Step Cocaine Screening Test (9070)

- Pathway: 510(k) (Traditional)
- Applicant: Phamatech
- Decided: Aug 8, 1997 after 28 days
- Product code: DMN (Thin Layer Chromatography, Cocaine)
- Device class: 2
- Regulation: 21 CFR 862.3250
- 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 Cocaine 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 law enforcement agencies is an in-vitro diagnostic test for the qualitative or quantitative identification of cocaine and cocaine metabolite (benzoylecgonine), in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

Source page: https://510kreport.com/device/K972618
Methodology: https://510kreport.com/methodology