# K924476: The Triage II

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Jan 22, 1993 after 141 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: 1 (0 Class I)
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jan 4, 2012 · Not classified · Z-1130-2012: Alere San Diego received a rise in customer complaints regarding false positive Barbiturates (BAR) results on the Triage Drugs of Abuse Panel Plus TCA.

Source page: https://510kreport.com/device/K924476
Methodology: https://510kreport.com/methodology