510(k) · Cleared
ClearedOmega Laboratories Hair Drug Screening Assay for Opiates
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 Dec 13, 2011 as substantially equivalent to K042725 (Quest Diagnostics, Inc., 2005) and 1 other predicate after a 412-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it.
- Decided
- Dec 13, 2011
- Review
- 412 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K014101 (2002). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK014101 Rapidone-Oxy TestAmerican Bio Medica Corp. · 2002
- This deviceK103161 Omega Laboratories Hair Drug Screening Assay for OpiatesOmega Laboratories, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK140671 Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone…Omega Laboratories, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K140671Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and HydrocodoneOmega 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 | K014101 | Rapidone-Oxy Test | American Bio Medica Corp. | 2002 | — |
| 0 (this device) | K103161 | Omega Laboratories Hair Drug Screening Assay for Opiates | Omega Laboratories, Inc. | 2011 | — |
| +1 | 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 |
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 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? (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 |
|---|---|---|---|
| * | K042725 | Quest Diagnostics Haircheck-DT (Opiates)Summary page 1…Hair Drug Screening Assay Opiates Regulation Number: CFR 862.3650 (ProCode DJG) Predicate Device: Quest Diagnostics HairCheck-DT (Opiates) k042725; RadipOne -OXY Test (American Bia Medica Corporation) (Oxycodone) K01 4101 Product Description:… | 2005 |
| * | K014101 | Rapidone-Oxy TestSummary page 1…te Device: Quest Diagnostics HairCheck-DT (Opiates) k042725; RadipOne -OXY Test (American Bia Medica Corporation) (Oxycodone) K01 4101 Product Description: The Omega Laboratories Hair Drug Screening Assays for Opiates, Oxyc… | 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 |
|---|---|---|---|
| K140671 | Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone | 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K140671 (Omega Laboratories, Inc., 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Assays are test systems that utilize ELISA assays for the qualitative detection of morphine and related opiates (calibrated with morphine) and oxycodone and hydrocodone (calibrated with oxycodone) at or above 300 pg/mg in head hair samples. The Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone provide only preliminary analytical test results. A more specific alternate chemical…
Read the full statement (163 words)
The Omega Laboratories Hair Drug Screening Assays are test systems that utilize ELISA assays for the qualitative detection of morphine and related opiates (calibrated with morphine) and oxycodone and hydrocodone (calibrated with oxycodone) at or above 300 pg/mg in head hair samples.
The Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone provide only preliminary analytical test results. 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 or GC/MS/MS in selected reaction mode (SRM) 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.
These laboratory developed tests are intended exclusively for in-house professional use only and are not intended for sale to anyone. Omega offers these laboratory developed tests as services to its clients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103161: Omega Laboratories Hair Drug Screening Assay for Opiates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103161
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