510(k) · Cleared
ClearedOmega Laboratories Hair Drug Screening Assay for Methamphetamine and 4-Methylenedioxymethamphetamine (Mdma)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omega Laboratories, Inc. · LAF Gas Chromatography, Methamphetamine
Cleared on Aug 16, 2011 as substantially equivalent to K051161 (Quest Diagnostics, Inc., 2005) after a 399-day review. Its family tree reaches back 1 generation to 2005. 1 later device descends from it.
- Decided
- Aug 16, 2011
- Review
- 399 days
- Class
- Class II
- Product code
- LAF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K051161 (2005). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK051161 Quest Diagnostics Haircheck-DT (Amphetamines)Quest Diagnostics, Inc. · 2005
- This deviceK101973 Omega Laboratories Hair Drug Screening Assay for Methamphetamine and…Omega Laboratories, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK142855 Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth)…Omega Laboratories, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K142855Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3…Omega Laboratories, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K051161 | Quest Diagnostics Haircheck-DT (Amphetamines) | Quest Diagnostics, Inc. | 2005 | — |
| 0 (this device) | K101973 | Omega Laboratories Hair Drug Screening Assay for Methamphetamine and… | Omega Laboratories, Inc. | 2011 | — |
| +1 | K142855 | Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3… | Omega Laboratories, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 LAF? 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 LAF device
- #1 K203647 SEFRIA Methamphetamine Oral Fluid Enzyme…score 3.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K051161 | Quest Diagnostics Haircheck-DT (Amphetamines)Summary page 1…Methamphetamine test System Classification Panel: 91 (Toxicology) Predicate Device: Quest Diagnostics HairCheck-DT (Amphetamines) k051161; Product Description: The Omega Laboratories Hair Drug Screening Assays for Opiates, O… | 2005 |
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 |
|---|---|---|---|
| K142855 | Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3… | 2015 | 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?
- Its one ancestor has no recall.
- Of its descendants, K142855 (Omega Laboratories, Inc., 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LAF devicesLAF Gas Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LAF
2in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · LAF
43in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LAF
No recall names LAF since 2007.
Adverse event reports per year · LAF
No MAUDE report names LAF since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 345 | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 43 | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 0 | — | 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 Methamphetamine and ,4-Methylenedioxymethamphetamine (MDMA) is a laboratory developed test that is intended to be used for the determination of the presence of Methamphetamine and 3,4-Methylenedioxymethamphetamine (MDMA) in human hair from the crown of the head. The Omega Laboratories Hair Drug Screening Assay (Meth -MDMA) utilizes International Diagnostics Systems Corp One-Step Methamphetamine ELISA for…
Read the full statement (183 words)
The Omega Laboratories Hair Drug Screening Assay Methamphetamine and ,4-Methylenedioxymethamphetamine (MDMA) is a laboratory developed test that is intended to be used for the determination of the presence of Methamphetamine and 3,4-Methylenedioxymethamphetamine (MDMA) in human hair from the crown of the head. The Omega Laboratories Hair Drug Screening Assay (Meth -MDMA) utilizes International Diagnostics Systems Corp One-Step Methamphetamine ELISA for Hair Testing Kit for the qualitative detection of Methamphetamine and MDMA at or above 500 pg/mg of hair for the purpose of identifying the use of Methamphetamine and MDMA. D-Methamphetamine is used as the standard for the assay. 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/K101973 · printed Nov 5, 2026
Cite this page
510(k) Report. “K101973: Omega Laboratories Hair Drug Screening Assay for Methamphetamine and 4-Methylenedioxymethamphetamine (Mdma).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K101973
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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