Cleared Traditional

K172569 - GenePOC CDiff (FDA 510(k) Clearance)

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

K172569 · Genepoc, Inc. · Microbiology device
Nov 2017
Decision
89d
Days
Class 2
Risk

K172569 is an FDA 510(k) clearance for the GenePOC CDiff. Classified as C. Difficile Toxin Gene Amplification Assay (product code OZN), Class II - Special Controls.

Submitted by Genepoc, Inc. (Quebec, CA). The FDA issued a Cleared decision on November 22, 2017 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3130 - the FDA microbiology 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.

Submission Details

510(k) Number K172569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2017
Decision Date November 22, 2017
Days to Decision 89 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 174d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OZN C. Difficile Toxin Gene Amplification Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3130
Definition Amplification Assay For The Detection Of C. Difficile Toxin Genes From Stool Specimens Of Symptomatic Patients.
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 Microbiology devices follow this clearance model.