# K043242: Triage Tox Drug Screen

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Feb 28, 2005 after 97 days
- Product code: LDP (Colorimetry, Acetaminophen)
- Device class: 2
- Regulation: 21 CFR 862.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K012745 (2002). 1 ancestor in all.
4 later devices descend from it; 3 cite 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)
- K012745: Triage Tox Drug Screen, Catalog #94000, Biosite Incorporated (2002) Summary page 1.

## Most influential descendants
- 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

## Recalls of this device
- Jul 12, 2012 · Class II · Z-2460-2012: Alere San Diego is recalling Alere Triage TOX Drug Screen because there is a possibility that after installing the code chip provided with the affected lots: AMP, BAR, and PCP, the threshold ranges ma

## Indications for use
The Triage ® TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage MeterPlus for the point-of-care qualitative determination of the presence of major metabolites above the threshold concentrations of up to 8 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses.

Source page: https://510kreport.com/device/K043242
Methodology: https://510kreport.com/methodology