# K112808: Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites

- Pathway: 510(k) (Traditional)
- Applicant: Omega Laboratories, Inc.
- Decided: Jan 23, 2012 after 118 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K023626 (2003). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023626: Aml Haircheck-DT (Cocaine), Quest Diagnostics, Inc. (2003) Summary page 1.

## Most influential descendants
- K131128: Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites (2013), 0 descendants of its own

## Indications for use
The Omega Laboratories Hair Drug Screening Assay for Cocaine and Cocaine Metabolites (Cocaine) is a laboratory developed test that is intended to be used for the determination of the presence of Cocaine in human hair from the head. The Omega Laboratories Hair Drug Screening Assay Cocaine utilizes the International Diagnostics Systems Corp. One-Step enzyme linked inmmosorbent assay (ELISA) for Cocaine Testing Kit, for the qualitative detection of Cocaine at or above 500 pglmg of hair for the purpose of identifying the use of Cocaine. To confirmn a screen positive result, a more specific alternate chemical method, such as Gas Chromatography/Mass Spectrometry (GCIMS) 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 laboratory developed test is intended exclusively for in-house laboratory use only and is not intended for sale to anyone. Omega offers this laboratory developed test as a service to its clients.

Source page: https://510kreport.com/device/K112808
Methodology: https://510kreport.com/methodology