Cleared Dual Track

K201269 - Accula Strep A Test

K201269 is an FDA 510(k) clearance for Accula Strep A Test, manufactured by Mesa Biotech, Inc.. The device is a Class 2 Microbiology device with product code PGX cleared through the Dual Track 510(k) pathway after a 181-day FDA review.

K201269 · Mesa Biotech, Inc. · Microbiology device
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Nov 2020
Decision
181d
Days
Class 2
Risk

K201269 is an FDA 510(k) clearance for the Accula Strep A Test. Classified as Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System (product code PGX), Class II - Special Controls.

Submitted by Mesa Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on November 9, 2020 after a review of 181 days - an extended review cycle.

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 Mesa Biotech, Inc. devices

FDA 510(k) Submission Details - K201269

510(k) Number K201269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 102d · This submission: 181d
Pathway characteristics

PGX Device Classification - Class 2, Special Controls

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.

Regulatory Peers - PGX Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System

All 14
Devices cleared under the same product code (PGX) and FDA review panel - the closest regulatory comparables to K201269.
cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190)
K260047 · Roche Molecular Systems, Inc. · Aug 2026
LIAISON NES Group A Strep
K260333 · Diasorin Molecular, LLC · Jun 2026
GenePOC Strep A
K183366 · Genepoc, Inc. · Mar 2019
Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit
K173653 · Alere Scarborough, Inc. · May 2018
Xpert Xpress Strep A
K173398 · Cepheid · Apr 2018
ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit
K172402 · Luminex Corporation · Oct 2017