Cleared Traditional

K183366 - GenePOC Strep A (FDA 510(k) Clearance)

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

K183366 · Genepoc, Inc. · Microbiology device
Mar 2019
Decision
92d
Days
Class 2
Risk

K183366 is an FDA 510(k) clearance for the GenePOC Strep A. Classified as Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System (product code PGX), Class II - Special Controls.

Submitted by Genepoc, Inc. (Quebec, CA). The FDA issued a Cleared decision on March 6, 2019 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2680 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K183366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2018
Decision Date March 06, 2019
Days to Decision 92 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 174d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PGX Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.2680
Definition An In Vitro Diagnostic Test For The Detection Of Group A, C And G Beta Hemolytic Streptococcus In Throat Swab Specimens From 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.