Cleared Traditional

K192943 - CEDIA Heroin Metabolite (6-AM) assay

K192943 is the FDA 510(k) clearance for CEDIA Heroin Metabolite (6-AM) assay by Microgenics Corporation. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K192943 · Microgenics Corporation · Toxicology device
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Dec 2019
Decision
59d
Days
Class 2
Risk

K192943 is an FDA 510(k) clearance for the CEDIA Heroin Metabolite (6-AM) assay. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Microgenics Corporation (Fremont, US). The FDA issued a Cleared decision on December 16, 2019 after a review of 59 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Microgenics Corporation devices

Submission Details

510(k) Number K192943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 2019
Decision Date December 16, 2019
Days to Decision 59 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 87d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 136
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