# K012745: Triage Tox Drug Screen, Catalog #94000

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Jan 10, 2002 after 147 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K043242: Triage Tox Drug Screen (2005), 4 descendants of its own
- K182719: Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro (2019), 1 descendant of its own
- K200363: Quidel Triage® TOX Drug Screen, 94600 (2020), 0 descendants of its own
- K080347: Uniscan -Doa System (2008), 0 descendants of its own
- K060791: Triage Tox Drug Screen, Model 94400 (2006), 0 descendants of its own

## Indications for use
The Triage® TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage® Meter for the point-of-care semi-quantitative or qualitative determination of major metabolites of amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC, and tricyclic antidepressants in urine.

Source page: https://510kreport.com/device/K012745
Methodology: https://510kreport.com/methodology