# K103161: Omega Laboratories Hair Drug Screening Assay for Opiates

- Pathway: 510(k) (Traditional)
- Applicant: Omega Laboratories, Inc.
- Decided: Dec 13, 2011 after 412 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- 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 K014101 (2002). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042725: Quest Diagnostics Haircheck-DT (Opiates), Quest Diagnostics, Inc. (2005) Summary page 1.
- K014101: Rapidone-Oxy Test, American Bio Medica Corp. (2002) Summary page 1.

## Most influential descendants
- K140671: Omega Laboratories Hair Drug Screening Assay for Opiates, Oxycodone and Hydrocodone (2015), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K103161
Methodology: https://510kreport.com/methodology