# K122759: Omega Laboratories Hair Drug Screening Assay Cardoxy-THC (Thca)

- Pathway: 510(k) (Traditional)
- Applicant: Omega Laboratories, Inc.
- Decided: Dec 5, 2012 after 86 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011426 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111929: Psychemedics Cannabinoids Eia, Psychemedics Corp. (2012) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K122759
Methodology: https://510kreport.com/methodology