Cleared Traditional

K231007 - CEDIA Heroin Metabolite (6-AM) Assay

K231007 is an FDA 510(k) clearance for CEDIA Heroin Metabolite (6-AM) Assay, manufactured by Microgenics Corporation. The device is a Class 2 Chemistry device with product code DJG cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K231007 · Microgenics Corporation · Chemistry device
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Sep 2023
Decision
173d
Days
Class 2
Risk

K231007 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 September 27, 2023 after a review of 173 days - an extended review cycle.

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

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Microgenics Corporation devices

FDA 510(k) Submission Details - K231007

510(k) Number K231007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2023
Decision Date September 27, 2023
Days to Decision 173 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 88d · This submission: 173d
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 Chemistry devices follow this clearance model.

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All 149
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