Panther Fusion AdV/hMPV/RV Assay
FDA 510(k) K231017 · Hologic, Inc.
510(k) numberK231017
Submission
- Device name
- Panther Fusion AdV/hMPV/RV Assay
- Applicant
- Hologic, Inc.
San Diego, CA, US - Received
- April 10, 2023
- Decision date
- May 5, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCC – Respiratory Virus Panel Nucleic Acid Assay System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3980
- Specialty
- Microbiology
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…
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Questions and answers
When was Panther Fusion AdV/hMPV/RV Assay cleared by the FDA?
Panther Fusion AdV/hMPV/RV Assay (K231017) received a 510(k) decision of Substantially Equivalent on May 5, 2023, 25 days after the submission was received.
What is the product code of K231017?
The FDA product code is OCC – Respiratory Virus Panel Nucleic Acid Assay System, a Class II (moderate risk) device regulated under 21 CFR 866.3980.