Cleared Special

K231017 - Panther Fusion AdV/hMPV/RV Assay

K231017 is an FDA 510(k) clearance for Panther Fusion AdV/hMPV/RV Assay, manufactured by Hologic, Inc.. The device is a Class 2 Microbiology device with product code OCC cleared through the Special 510(k) pathway after a 25-day FDA review.

K231017 · Hologic, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
25d
Days
Class 2
Risk

K231017 is an FDA 510(k) clearance for the Panther Fusion AdV/hMPV/RV Assay. Classified as Respiratory Virus Panel Nucleic Acid Assay System (product code OCC), Class II - Special Controls.

Submitted by Hologic, Inc. (San Diego, US). The FDA issued a Cleared decision on May 5, 2023 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3980 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K231017

510(k) Number K231017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 102d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

OCC Device Classification - Class 2, Special Controls

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 79
Devices cleared under the same product code (OCC) and FDA review panel - the closest regulatory comparables to K231017.
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K231017 · Panther Fusion AdV/hMPV/RV Assay
Download PDF FDA Summary Hologic, Inc.