# K060791: Triage Tox Drug Screen, Model 94400

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Jun 22, 2006 after 91 days
- Product code: DJR (Enzyme Immunoassay, Methadone)
- Device class: 2
- Regulation: 21 CFR 862.3620
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K012745 (2002). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973784: Triage Panel for Drugs of Abuse, Plus Tricyclic Antidepressants and Other Triage Drug Tests, Biosite Incorporated (1997) Summary page 1.
- K043242: Triage Tox Drug Screen, Biosite Incorporated (2005) Summary page 1.

## Recalls of this device
- Feb 5, 2014 · Class II · Z-1214-2014: Alere San Diego, Inc. is initiating a recall of the Alere Triage¿ TOX Drug Screen, Catalog Number 94400, Lots W56013B and W56035B because Alere's investigation has shown that these lots have a frequen
- 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
- May 14, 2012 · Class II · Z-2039-2012: A recall was initiated because Alere San Diego has confirmed that the Triage TOX Drug Screen may have significantly decreased precision and accuracy than claimed. An increased frequency of false posit
- Mar 12, 2010 · Not classified · Z-1446-2012: The recall was initiated because Biosite Inc. received an increase in customer calls regarding unexpected positive THC results when using the Triage TOX Drug Screen.
- May 28, 2009 · Class II · Z-0029-2013: Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled.

## Indications for use
The Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Triage Meters for the point-of-care qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, 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. The threshold concentrations are provided below: Acetaminophen/Paracetamol APAP 5 pg/mL Amphetamines AMP 1000 ng/mL Methamphetamines mAMP 1000 ng/mL Barbiturates BAR 300 ng/mL Benzodiazepines BZO 300 ng/mL Cocaine COC 300 ng/mL Methadone MTD 300 ng/mL Opiates OPI 300 ng/mL Phencyclidine PCP 25 ng/mL THC THC 50 ng/mL Tricyclic Antidepressants TCA 1000 ng/mL This test provides only preliminary test results. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) is the preferred confirmatory method. A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results.

Source page: https://510kreport.com/device/K060791
Methodology: https://510kreport.com/methodology