# K051161: Quest Diagnostics Haircheck-DT (Amphetamines)

- Pathway: 510(k) (Traditional)
- Applicant: Quest Diagnostics, Inc.
- Decided: Nov 22, 2005 after 201 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K101973: Omega Laboratories Hair Drug Screening Assay for Methamphetamine and 4-Methylenedioxymethamphetamine (Mdma) (2011), 1 descendant of its own
- K142855: Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA) (2015), 0 descendants of its own

## Indications for use
QUEST DIAGNOSTICS HairCheck-DT (Amphetamines) is a test system that utilizes the IDS One-Step ELISA MDMA/Methamphetamine Kit for the qualitative detection of amphetamines at concentrations at or above 300 pg/mg hair for the purpose of identifying chronic methamphetamine use and use of MDMA. This test system has not been evaluated for use with other populations or with hair specimens other than head. It is an in vitro diagnostic device intended exclusively for in-house professional use only and not intended for sale to anyone. The QUEST DIAGNOSTICS HairCheck-DT (Amphetamines) provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed result. Gas Chromatograph - Mass Spectrometry operating in the selected ion monitoring (SIM) mode or GC/MS/MS in selected reaction mode (SRM) is the preferred method with deuterated internal standards. Other chemical confirmation methods are available. 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/K051161
Methodology: https://510kreport.com/methodology