Cleared Traditional

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

Class II Microbiology device cleared through predicate-based substantial equivalence.

K183366 · Genepoc, Inc. · Microbiology device
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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.

View all Genepoc, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 102d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Microbiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03422341 Completed Interventional Industry-sponsored

Validation of the GenePOC Strep A, C/G Assay for Detecting Group A, C and G β-hemolytic Streptococcus From Throat Swabs.

Prospective Study for Clinical Validation of the Molecular-Based GenePOC Strep A, C/G Assay for the Detection and Identification of Group A β-hemolytic Streptococcus (Streptococcus Pyogenes) and Pyogenic Group C and G β-hemolytic Streptococcus (Streptococcus Dysgalactiae Subsp. Equisimilis) Nucleic Acids From Throat Swab Samples Obtained From Patients With Signs and Symptoms of Pharyngitis.

497
Patients (actual)
8
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Pharyngitis, Infective
Study design Single group
Eligibility All sexes · 25 Months+
Principal investigator Patrice Allibert
Sponsor Meridian Bioscience, Inc. (industry)
Started 2018-02-14 → Primary completion 2018-07-11
Primary outcome
Performance characteristics of the GenePOC Streap A, C/G assay
Secondary outcome
Positive and Negative Predictive Values (PPV and NPV)
Study completed - no results published. This trial concluded in 2018 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov