Cleared Traditional

GenePOC Strep A

K183366 · Genepoc, Inc. · Microbiology

Mar 2019

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K183366 is an FDA 510(k) clearance for the GenePOC Strep A, a Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System (Class II — Special Controls, product code PGX), submitted by Genepoc, Inc. (Quebec, CA). The FDA issued a Cleared decision on March 6, 2019, 92 days after receiving the submission on December 4, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2680.

Submission Details

510(k) Number	K183366 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	PGX — Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System
Device Class	Class II — 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.