# K014247: Triage Drugs of Abuse Panel Plus PPX, Model Catalog 92002

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Jun 3, 2002 after 159 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. The FDA summary names its predicate without a number.
- (no number) Triage® Drugs of Abuse Panel plus TCA: named in the summary without a submission number
- (no number) TDXRDXFLX Propoxyphene test: named in the summary without a submission number

## Indications for use
The Triage® Drugs of Abuse Panel Plus PPX is a competitive immunoassay used for the qualitative determination of the presence of the major metabolites of amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC, tricyclic antidepressants, and propoxyphene in urine.

Source page: https://510kreport.com/device/K014247
Methodology: https://510kreport.com/methodology