# K023626: Aml Haircheck-DT (Cocaine)

- Pathway: 510(k) (Traditional)
- Applicant: Quest Diagnostics, Inc.
- Decided: Sep 29, 2003 after 335 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K112808: Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites (2012), 1 descendant of its own
- K152232: Quest Diagnostics HairCheck-DT (Cocaine) (2016), 0 descendants of its own
- K131128: Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites (2013), 0 descendants of its own

## Indications for use
AML Haircheck-DT (Cocaine) is a process that utilizes the IDS One-Step ELISA Cocaine Kit in which head hair samples undergo forensic testing for the qualitative detection of cocaine at concentrations at or above 300 pg/mg hair for the purpose of identifying chronic cocaine 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. The AML Haircheck-DT (Cocaine) provides only a preliminary analytical test result. For a quantitative analytical result or for confirmation, presumptive positives are analyzed using a gas chromatograph - mass spectrometer operating in the selected ion monitoring mode using the deuterated internal standards. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

Source page: https://510kreport.com/device/K023626
Methodology: https://510kreport.com/methodology