Cleared Special

Panther Fusion AdV/hMPV/RV Assay

K231017 · Hologic, Inc. · Microbiology

May 2023

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K231017 is an FDA 510(k) clearance for the Panther Fusion AdV/hMPV/RV Assay, a Respiratory Virus Panel Nucleic Acid Assay System (Class II — Special Controls, product code OCC), submitted by Hologic, Inc. (San Diedgo, US). The FDA issued a Cleared decision on May 5, 2023, 25 days after receiving the submission on April 10, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number	K231017 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 10, 2023
Decision Date	May 05, 2023
Days to Decision	25 days
Submission Type	Special
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.