Cleared Traditional

K103161 - OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES

K103161 is an FDA 510(k) clearance for OMEGA LABORATORIES HAIR DRUG SCREENING ..., manufactured by Omega Laboratories, Inc.. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 412-day FDA review.

K103161 · Omega Laboratories, Inc. · Toxicology device
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Dec 2011
Decision
412d
Days
Class 2
Risk

K103161 is an FDA 510(k) clearance for the OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR OPIATES. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Omega Laboratories, Inc. (Mogadore, US). The FDA issued a Cleared decision on December 13, 2011 after a review of 412 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Toxicology submissions.

View all Omega Laboratories, Inc. devices

FDA 510(k) Submission Details - K103161

510(k) Number K103161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2010
Decision Date December 13, 2011
Days to Decision 412 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
325d slower than avg
Panel avg: 87d · This submission: 412d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJG Device Classification - Class 2, Special Controls

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DJG Enzyme Immunoassay, Opiates

All 189
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