# K200363: Quidel Triage® TOX Drug Screen, 94600

- Pathway: 510(k) (Special)
- Applicant: Quidel Cardiovascular, Inc.
- Decided: Mar 11, 2020 after 26 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
Longest line of descent: 4 generations back to K973547 (1998). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182719: Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro, Quidel Cardiovascular, Inc. (2019) Summary page 7.

## Indications for use
The Quidel Triage® TOX Drug Screen, 94600 is a fluorescence immunoassay to be used with the Quidel Triage® MeterPro for the qualitative determination of the presence of drugs and/or metabolites in human urine of up to 9 drug assays at or above the threshold concentrations. The threshold concentrations are provided below: Abbreviation Analyte Calibrator Cutoff AMP Amphetamines d-Amphetamine 500 ng/mL mAMP Methamphetamines d-Methamphetamine 500 ng/mL BAR Barbiturates Butalbital 200 ng/mL BZO Benzodiazepines Temazepam 200 ng/mL COC Cocaine Benzoylecgonine 150 ng/mL EDDP Methadone Metabolite EDDP 100 ng/mL OPI Opiates Morphine 300 ng/mL THC Cannabinoids 11-nor-9-carboxy-Δ9-THC 50 ng/mL TCA Tricyclic Antidepressants Desipramine 1000 ng/mL This test provides only a preliminary test result. Clinical consideration and professional judgment must be applied to any drug test result, particularly in evaluating a preliminary positive result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas Chromatography / Mass Spectroscopy (GC/MS), Liquid Chromatography / Mass Spectroscopy / Mass Spectroscopy (LC-MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods.

Source page: https://510kreport.com/device/K200363
Methodology: https://510kreport.com/methodology