510(k) · Cleared
ClearedOmega Laboratories Hair Drug Screening Assay Cardoxy-THC (Thca)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omega Laboratories, Inc. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Dec 5, 2012 as substantially equivalent to K111929 (Psychemedics Corp., 2012) after an 86-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Dec 5, 2012
- Review
- 86 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011426 (2002). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 LDJ? 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 LDJ device
- #1 K232732 Rapid Marijuana (THC) Test Strip 20, Rapid…score 9.4 · 10 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 |
|---|---|---|---|
| * | K111929 | Psychemedics Cannabinoids EiaSummary page 1…me: Enzyme immunoassay, Cannabinoids Classification Panel: 91 (Toxicology) Predicate Device: Psychemnedics Microplate EIA for Cannabinoids in Hair K1 11929 Product Description: The test consists of two padts; a pro-analytical proprietary and patent p… | 2012 |
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 10.0 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All LDJ devicesLDJ Enzyme Immunoassay, Cannabinoids: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LDJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LDJ
48in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDJ
1in 2015
MAUDE reports naming product code LDJ, 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 | 2 | — | 4 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 219 | 0 | 0 |
| 2012 | 4 | 193 | 0 | 0 |
| 2013 | 3 | 162 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 48 | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Omega Laboratories Hair Drug Screening Assay for Carboxy-THC (THCA) is an in vitro diagnostic that is intended to be used for the determination of the presence of canmabinoids in human head and body hair samples. The Omega Laboratories Hair Drug Screening Assay for Carboxy-THC utilizes the International Diagnostic Systems Corp. enzyme linked immunosorbant assay (ELISA) for THC Metabolite Testing Kit, for the qualitative detection of THCA at or above…
Read the full statement (168 words)
The Omega Laboratories Hair Drug Screening Assay for Carboxy-THC (THCA) is an in vitro diagnostic that is intended to be used for the determination of the presence of canmabinoids in human head and body hair samples. The Omega Laboratories Hair Drug Screening Assay for Carboxy-THC utilizes the International Diagnostic Systems Corp. enzyme linked immunosorbant assay (ELISA) for THC Metabolite Testing Kit, for the qualitative detection of THCA at or above 1 pg/mg of hair for the purpose of identify'ing the use of cannabinoids.
The Omega Laboratories Hair Drug Screening Assay for Carboxy-THC provides only preliminary analytical test results and must be used in combination with a more specific alternate chemical method 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 used as the confirmation method, along with deuterated internal standards.
Omega plans to perform this test at one site. Omega has not performed an evaluation of reproducibility at different laboratories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122759: Omega Laboratories Hair Drug Screening Assay Cardoxy-THC (Thca).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122759
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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