# K982152: Quick Screen Barbiturate Screening Test Models 9020 and 9021, Quick Screen Pro Multi Drug Screening Test Modl 9152

- Pathway: 510(k) (Traditional)
- Applicant: Phamatech
- Decided: Sep 21, 1998 after 95 days
- Product code: DIS (Enzyme Immunoassay, Barbiturate)
- Device class: 2
- Regulation: 21 CFR 862.3150
- 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) ABMC Rapid Drug Screen: named in the summary without a submission number
- (no number) Applied Biotech SureStep Test: named in the summary without a submission number

## Indications for use
An in vitro test for the qualitative identification of barbiturates-in urine at a cutoff concentration of 200 ng/mL of Secobarbital. Measurements that are obtained by this device are used in the screening for drug abuse.

Source page: https://510kreport.com/device/K982152
Methodology: https://510kreport.com/methodology