Cleared Dual Track

K171641 - Accula Flu A/Flu B Test

K171641 is the FDA 510(k) clearance for Accula Flu A/Flu B Test by Mesa Biotech, Inc.. It is a Class 2 Microbiology device (product code OZE) cleared through the Dual Track 510(k) pathway after a 249-day FDA review.

K171641 · Mesa Biotech, Inc. · Microbiology device
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Feb 2018
Decision
249d
Days
Class 2
Risk

K171641 is an FDA 510(k) clearance for the Accula Flu A/Flu B Test. Classified as Influenza A And Influenza B Multiplex Nucleic Acid Assay (product code OZE), Class II - Special Controls.

Submitted by Mesa Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on February 6, 2018 after a review of 249 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3980 - 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

Submission Details

510(k) Number K171641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2017
Decision Date February 06, 2018
Days to Decision 249 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
147d slower than avg
Panel avg: 102d · This submission: 249d
Pathway characteristics

Device Classification

Product Code OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3980
Definition An Influenza A And Influenza B Multiplex Nucleic Acid Assay Is A Multiplex In Vitro Diagnostic Test For The Simultaneous Qualitative Detection And Discrimination Of Influenza A And Influenza B Nucleic Acids Isolated And Purified From Human Respiratory Specimens Obtained From Individuals Exhibiting Signs And Symptoms Of Respiratory Tract Infections Or Viral Culture. The Detection And Discrimination Of Influenza A And B Nucleic Acids From Symptomatic Patients Aid In The Diagnosis Of Human Respiratory Tract Influenza Viral Infections If Used In Conjunction With Other Clinical And Laboratory Findings.
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 - OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay

All 12
Devices cleared under the same product code (OZE) and FDA review panel - the closest regulatory comparables to K171641.
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit
K190302 · Centers For Disease Control and Prevention · Mar 2019
ID NOW Influenza A & B 2
K190204 · Alere Scarborough, Inc. · Mar 2019
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit,
K181736 · Centers For Disease Control and Prevention (Cdc) · Jul 2018
QUIDEL MOLECULAR INFLUENZA A + B ASSAY
K131728 · Quidel Corp. · Aug 2013
QUIDEL MOLECULAR INFLUENZA A+B
K113777 · Quidel Corp. · Mar 2012