Cleared Traditional

K211973 - DRI Cocaine Metabolite Assay (FDA 510(k) Clearance)

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211973 · Microgenics Corporation · Toxicology device
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Sep 2021
Decision
91d
Days
Class 2
Risk

K211973 is an FDA 510(k) clearance for the DRI Cocaine Metabolite Assay. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by Microgenics Corporation (Fremont, US). The FDA issued a Cleared decision on September 24, 2021 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Microgenics Corporation devices

Submission Details

510(k) Number K211973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2021
Decision Date September 24, 2021
Days to Decision 91 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
4d slower than avg
Panel avg: 87d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 144
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