510(k) · Cleared
ClearedQuest Diagnostics Haircheck-DT (PCP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quest Diagnostics, Inc. · LCM Enzyme Immunoassay, Phencyclidine
Cleared on Jul 28, 2005 after a 300-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Jul 28, 2005
- Review
- 300 days
- Class
- Class U
- Product code
- LCM
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK042726 Quest Diagnostics Haircheck-DT (PCPQuest Diagnostics, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK101059 Omega Laboratories Hair Drug Screening Assay for PhencyclidineOmega Laboratories, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK131181 Omega Laboratories Hair Drug Screening Assay PhencyclidineOmega Laboratories, Inc. · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042726 | Quest Diagnostics Haircheck-DT (PCP | Quest Diagnostics, Inc. | 2005 | — |
| +1 | K101059 | Omega Laboratories Hair Drug Screening Assay for Phencyclidine | Omega Laboratories, Inc. | 2010 | — |
| +2 | K131181 | Omega Laboratories Hair Drug Screening Assay Phencyclidine | Omega Laboratories, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LCM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LCM device
- #1 K212952 Psychemedics Homogeneous Enzyme Immunoassay…score 3.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101059 | Omega Laboratories Hair Drug Screening Assay for Phencyclidine | 2010 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K101059 (Omega Laboratories, Inc., 2010) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LCM devicesLCM Enzyme Immunoassay, Phencyclidine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LCM
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LCM
Too few LCM 510(k)s in any year since 2007 to give a median.
Recalls per year · LCM
No recall names LCM since 2007.
Adverse event reports per year · LCM
2in 2019
MAUDE reports naming product code LCM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (156 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042726 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042726: Quest Diagnostics Haircheck-DT (PCP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042726
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026