510(k) · Cleared
ClearedOmega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omega Laboratories, Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on Jan 8, 2015 as substantially equivalent to K103161 (Omega Laboratories, Inc., 2011) after a 296-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Jan 8, 2015
- Review
- 296 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K014101 (2002). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK014101 Rapidone-Oxy TestAmerican Bio Medica Corp. · 2002
- 1 generation backK103161 Omega Laboratories Hair Drug Screening Assay for OpiatesOmega Laboratories, Inc. · 2011
- This deviceK140671 Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone…Omega Laboratories, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K014101 | Rapidone-Oxy Test | American Bio Medica Corp. | 2002 | — |
| −1 | K103161 | Omega Laboratories Hair Drug Screening Assay for Opiates | Omega Laboratories, Inc. | 2011 | — |
| 0 (this device) | K140671 | Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and… | Omega Laboratories, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 DJG? 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 DJG device
- #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 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 |
|---|---|---|---|
| * | K103161 | Omega Laboratories Hair Drug Screening Assay for OpiatesSummary page 4…Panel: 91 (Toxicology) Predicate Device: Omega Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone (k103161) Indication for Use: The Omega Laboratories Hair Drug Screening Assay (Opiates, Oxyco… | 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 13 years and passes through 2 companies; a new generation was cleared every 9.7 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
The Omega Laboratories Hair Drug Screening Assay (Opiates, Oxycodone and Hydrocodone) is an in vitro diagnostic test that is intended for the qualitative detection of opiates (calibrated with morphine) and oxycodone and hydrocodone (calibrated with oxycodone) at or above 300 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…
Read the full statement (118 words)
The Omega Laboratories Hair Drug Screening Assay (Opiates, Oxycodone and Hydrocodone) is an in vitro diagnostic test that is intended for the qualitative detection of opiates (calibrated with morphine) and oxycodone and hydrocodone (calibrated with oxycodone) at or above 300 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 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 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/K140671 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140671: Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140671
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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