510(k) · Cleared
ClearedOmega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omega Laboratories, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Jul 28, 2015 as substantially equivalent to K101973 (Omega Laboratories, Inc., 2011) after a 301-day review. Its family tree reaches back 2 generations to 2005.
- Decided
- Jul 28, 2015
- Review
- 301 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K051161 (2005). No later device cites it as a predicate yet.
- Root · 2 generations backK051161 Quest Diagnostics Haircheck-DT (Amphetamines)Quest Diagnostics, Inc. · 2005
- 1 generation backK101973 Omega Laboratories Hair Drug Screening Assay for Methamphetamine and…Omega Laboratories, Inc. · 2011
- This deviceK142855 Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth)…Omega Laboratories, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K051161 | Quest Diagnostics Haircheck-DT (Amphetamines) | Quest Diagnostics, Inc. | 2005 | — |
| −1 | K101973 | Omega Laboratories Hair Drug Screening Assay for Methamphetamine and… | Omega Laboratories, Inc. | 2011 | — |
| 0 (this device) | K142855 | Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3… | Omega Laboratories, Inc. | 2015 | — |
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 DKZ? 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 DKZ device
- #1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 8 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 |
|---|---|---|---|
| * | K101973 | Omega Laboratories Hair Drug Screening Assay for Methamphetamine and…Summary page 4…edicate Device: Omega Laboratories Hair Drug Screening Assay Methamphetamine_3, 4-methylenedioxymethamphetamine (Meth_MDMA) k101973 with the addition of the body hair as an assay matri.; Product Description: The Omega… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DKZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DKZ
180in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DKZ
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKZ
2in 2025
MAUDE reports naming product code DKZ, 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 | — | 1 | 0 |
| 2008 | 2 | — | 3 | 12 |
| 2009 | 2 | — | 5 | 1 |
| 2010 | 4 | 233 | 0 | 1 |
| 2011 | 6 | 123 | 4 | 2 |
| 2012 | 5 | 55 | 0 | 0 |
| 2013 | 8 | 103 | 1 | 1 |
| 2014 | 8 | 128 | 3 | 9 |
| 2015 | 5 | 107 | 0 | 8 |
| 2016 | 5 | 215 | 0 | 8 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 3 | 128 | 0 | 0 |
| 2019 | 3 | 180 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Omega Laboratories Hair Drug Screening Assay for Methamphetamine (Meth) and 3,4-Methylenedioxymethamphetamine (MDMA) is an in vitro diagnostic test that is intended for the qualitative detection of Methamphetamine (calibrated with Methamphetamine) and MDMA (calibrated with MDMA) at or above 500 pg/mg in human head and body hair. To confirm a screen positive result, a more specific alternate chemical method, such as Gas Chromatography/Mass…
Read the full statement (118 words)
The Omega Laboratories Hair Drug Screening Assay for Methamphetamine (Meth) and 3,4-Methylenedioxymethamphetamine (MDMA) is an in vitro diagnostic test that is intended for the qualitative detection of Methamphetamine (calibrated with Methamphetamine) and MDMA (calibrated with MDMA) at or above 500 pg/mg in human head and body hair. 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 with deuterated internal standards is the preferred method. Professional judgment should be applied to any drug of abuse test result, particularly when presumptive positive results are obtained.
This test is intended exclusively for single laboratory use only and is not intended for sale to anyone.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142855 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142855: Omega Laboratories Hair Drug Screening Assay Methamphetamine (Meth) and -3, 4-methylenedioxymethamphetamine (MDMA).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142855
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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