Cleared Dual Track

Accula RSV Test

K181443 · Mesa Biotech, Inc. · Microbiology

Nov 2018

Decision

176d

Days

Class 2

Risk

About This 510(k) Submission

K181443 is an FDA 510(k) clearance for the Accula RSV Test, a Respiratory Virus Panel Nucleic Acid Assay System (Class II — Special Controls, product code OCC), submitted by Mesa Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on November 23, 2018, 176 days after receiving the submission on May 31, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number	K181443 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	OCC — Respiratory Virus Panel Nucleic Acid Assay System
Device Class	Class II — 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.