# K982938: Quick Screen Methadone Screening Test, Models 9035, 9036, Quick Screen Pro Multi Drug Screening Test Model 9153

- Pathway: 510(k) (Traditional)
- Applicant: Phamatech
- Decided: Feb 5, 1999 after 168 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
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: 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 diagnostic test for the qualitative identification of methadone in urine. This test was calibrated against methadone at a cut-off concentration of 300 ng/ml. Measurements obtained by this device are used in screening for drug abuse.

Source page: https://510kreport.com/device/K982938
Methodology: https://510kreport.com/methodology