# K152232: Quest Diagnostics HairCheck-DT (Cocaine)

- Pathway: 510(k) (Traditional)
- Applicant: Quest Diagnostics Incorporated
- Decided: Nov 18, 2016 after 469 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K023626 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023626: Aml Haircheck-DT (Cocaine), Quest Diagnostics, Inc. (2003) Summary page 4.

## Indications for use
The Quest Diagnostics Hair Check-DT (Cocaine) test system utilizes an Enzyme Linked Immunosorbent Assay (ELISA) for the qualitative detection of cocaine in head hair samples through the measurement of cocaine and cocaine metabolites for concentrations at or above 300 pg/mg hair. This test system has not been evaluated for use with hair specimens from locations other than the head. It is an in vitro diagnostic device intended exclusively for in-house professional use and is not intended for sale to anyone. The Hair Check-DT (Cocaine) test system was evaluated in two distinct study populations; individuals known to be chronic drug abusers, and individuals proclaiming to be drug-free. The Quest Diagnostics Hair Check-DT (Cocaine) test system provides only a preliminary analytical test result. To confirm a presumptive screen positive result, a more specific alternate chemical method, such as gas chromatography - mass spectrometry (GC/MS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

Source page: https://510kreport.com/device/K152232
Methodology: https://510kreport.com/methodology