# K040257: Quest Diagnostics Haircheck-DT (THC)

- Pathway: 510(k) (Traditional)
- Applicant: Quest Diagnostics, Inc.
- Decided: Jun 14, 2004 after 131 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The QUEST DIAGNOSTICS HairCheck-DT (THC-COOH) is a bipartite device employing enzyme-linked immunosorbent assay (ELISA) for qualitative screening at 1.0 pg/mg of THC-COOH and Gas Chromatography - Mass Spectrometry - Mass Spectrometry (GC-MS-MS) for confirmation and the final quantitative reporting of THC-COOH in human hair samples for the purpose of identifying chronic marijuana use. This process has not been evaluated for use with hair specimens other than head. This process is intended exclusively for in-house professional use only. The process is not intended for sale to anyone. Clinical consideration and professional judgement should be applied to any drug of abuse test result.

Source page: https://510kreport.com/device/K040257
Methodology: https://510kreport.com/methodology