Cleared Dual Track

Accula Strep A Test

K201269 · Mesa Biotech, Inc. · Microbiology

Nov 2020

Decision

181d

Days

Class 2

Risk

About This 510(k) Submission

K201269 is an FDA 510(k) clearance for the Accula Strep A Test, a Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System (Class II — Special Controls, product code PGX), submitted by Mesa Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on November 9, 2020, 181 days after receiving the submission on May 12, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2680.

Submission Details

510(k) Number	K201269 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 12, 2020
Decision Date	November 09, 2020
Days to Decision	181 days
Submission Type	Dual Track
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.