510(k) · Cleared
ClearedOmega Laboratories Hair Drug Screening Assay for Phencyclidine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omega Laboratories, Inc. · LCM Enzyme Immunoassay, Phencyclidine
Cleared on Jul 12, 2010 as substantially equivalent to K042726 (Quest Diagnostics, Inc., 2005) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it.
- Decided
- Jul 12, 2010
- Review
- 88 days
- Class
- Class U
- Product code
- LCM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K011275 (2002). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK011275 Psychemedics Ria Phencyclidine AssayPsychemedics Corp. · 2002
- This deviceK101059 Omega Laboratories Hair Drug Screening Assay for PhencyclidineOmega Laboratories, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK131181 Omega Laboratories Hair Drug Screening Assay PhencyclidineOmega Laboratories, Inc. · 2013
Most influential descendants
Showing 1 of 1 · See all- K131181Omega Laboratories Hair Drug Screening Assay PhencyclidineOmega Laboratories, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011275 | Psychemedics Ria Phencyclidine Assay | Psychemedics Corp. | 2002 | — |
| 0 (this device) | K101059 | Omega Laboratories Hair Drug Screening Assay for Phencyclidine | Omega Laboratories, Inc. | 2010 | — |
| +1 | K131181 | Omega Laboratories Hair Drug Screening Assay Phencyclidine | Omega Laboratories, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042726 | Quest Diagnostics Haircheck-DT (PCPSummary page 2…Unclassified, Enzyme Immunoassay, POP 2.0 PREDICATE DEVICES 2.1 Quest Diagnostics HairCheck-DT (POP) 2.1.1 510(k) Number: k042726 2.2 Psychemedics Corporation RIA Phencyclidine (POP) Assay 2.2.1 510(k) Number: k011275 3.0… | 2005 |
| * | K011275 | Psychemedics Ria Phencyclidine AssaySummary page 2…POP) 2.1.1 510(k) Number: k042726 2.2 Psychemedics Corporation RIA Phencyclidine (POP) Assay 2.2.1 510(k) Number: k011275 3.0 INTENDED USE AND INDICATIONS FOR USE 3.1 The Omega Laboratories Hair Drug Screening Assay Phencyclidine… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131181 | Omega Laboratories Hair Drug Screening Assay Phencyclidine | 2013 | 0 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K131181 (Omega Laboratories, Inc., 2013) has gone furthest, with 0 descendants 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. 2010, this device’s year, is highlighted.
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 Omega Laboratories Hair Drug Screening Assay Phencyclidine (PCP) is a laboratory developed test that is intended to be used for the determination of the presence of PCP in human hair from the head. The Omega Laboratories Hair Drug Screening Assay (PCP) utilizes the International Diagnostic Systems Corp (IDS) One-Step enzyme linked immunosorbent assay (ELISA) for PCP, for the qualitative detection of PCP at or above 300 pg/mg of hair for the purpose…
Read the full statement (164 words)
The Omega Laboratories Hair Drug Screening Assay Phencyclidine (PCP) is a laboratory developed test that is intended to be used for the determination of the presence of PCP in human hair from the head. The Omega Laboratories Hair Drug Screening Assay (PCP) utilizes the International Diagnostic Systems Corp (IDS) One-Step enzyme linked immunosorbent assay (ELISA) for PCP, for the qualitative detection of PCP at or above 300 pg/mg of hair for the purpose of identifying the use of PCP. To. confirm a screen positive result, a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry (GC/MS) operating in the selected ion monitoring (SIM) mode is the preferred method with deuterated internal standards. Professional judgment should be applied to any drug of abuse test result, particularly when presumptive positive results are obtained.
This laboratory developed test is intended exclusively for in-house laboratory use only and is not intended for sale to anyone. Omega offers this laboratory developed test as a service to its clients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101059: Omega Laboratories Hair Drug Screening Assay for Phencyclidine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101059
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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