# K042726: Quest Diagnostics Haircheck-DT (PCP

- Pathway: 510(k) (Traditional)
- Applicant: Quest Diagnostics, Inc.
- Decided: Jul 28, 2005 after 300 days
- Product code: LCM (Enzyme Immunoassay, Phencyclidine)
- Device class: U
- 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
- K101059: Omega Laboratories Hair Drug Screening Assay for Phencyclidine (2010), 1 descendant of its own
- K131181: Omega Laboratories Hair Drug Screening Assay  Phencyclidine (2013), 0 descendants of its own

## Indications for use
The Quest Diagnostics Hair Check-DT (PCP) is a test system that utilizes the IDS One-Step ELISA PCP Kit for the qualitative detection of Phencyclidine at or above 300 pg/mg in head hair samples. This test system has not been evaluated for use in specific user populations or with hair specimens other than the head. It is an in vitro diagnostic device intended exclusively for in-house professional use only and is not intended for sale to anyone. The Quest Diagnostics Hair Check-DT (PCP) screening test 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 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/K042726
Methodology: https://510kreport.com/methodology