Cleared Dual Track

K181443 - Accula RSV Test

K181443 is the FDA 510(k) clearance for Accula RSV Test by Mesa Biotech, Inc.. It is a Class 2 Microbiology device (product code OCC) cleared through the Dual Track 510(k) pathway after a 176-day FDA review.

K181443 · Mesa Biotech, Inc. · Microbiology device
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Nov 2018
Decision
176d
Days
Class 2
Risk

K181443 is an FDA 510(k) clearance for the Accula RSV Test. Classified as Respiratory Virus Panel Nucleic Acid Assay System (product code OCC), Class II - Special Controls.

Submitted by Mesa Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on November 23, 2018 after a review of 176 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 K181443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2018
Decision Date November 23, 2018
Days to Decision 176 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
74d slower than avg
Panel avg: 102d · This submission: 176d
Pathway characteristics

Device Classification

Product Code OCC Respiratory Virus Panel Nucleic Acid Assay System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3980
Definition A Respiratory Viral Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Viral Nucleic Acids Extracted From Human Respiratory Specimens Or Viral Culture. The Detection And Identification Of A Specific Viral Nucleic Acid From Individuals Exhibiting Signs And Symptoms Of Respiratory Infection Aids In The Diagnosis Of Respiratory Viral Infection When Used In Conjunction With Other Clinical And Laboratory Findings. The Device Is Intended For Detection And Identification Of A Combination Of The Following Viruses: Influenza A And Influenza B, Influenza A Subtype H1 And Influenza A Subtype H3, Respiratory Syncytial Virus Subtype A And Respiratory Syncytial Virus Subtype B, Parainfluenza 1, Parainfluenza 2, And Parainfluenza 3 Virus, Human Metapneumovirus, Rhinovirus, And Adenovirus.
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 - OCC Respiratory Virus Panel Nucleic Acid Assay System

All 31
Devices cleared under the same product code (OCC) and FDA review panel - the closest regulatory comparables to K181443.
Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
K191729 · Roche Molecular Systems, Inc. · Jul 2019
ID NOW Influenza A & B 2
K191534 · Abbott Diagnostics Scarborough, Inc. · Jul 2019
QIAstat-Dx Respiratory Panel
K183597 · QIAGEN GmbH · May 2019
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System
K181289 · Cepheid · Aug 2018
Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
K180218 · Cepheid · Jul 2018
Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2
K173932 · Alere Scarborough, Inc. · Jan 2018