# K172282: Panther Fusion Paraflu Assay

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Oct 23, 2017 after 87 days
- Product code: OOU (Parainfluenza Multiplex Nucleic Acid Assay)
- Device class: 2
- Regulation: 21 CFR 866.3980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to DEN070013 (2008). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153223: ProParaFlu+ Assay, Hologic, Inc. (2015) Summary page 4.

## Indications for use
The Panther Fusion Paraflu assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus (HPIV-1, HPIV-2, HPIV-3, and HPIV-4). Nucleic acids are isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection. This assay is intended to aid in the differential diagnosis of HPIV-1, HPIV-2, HPIV-3, and HPIV-4 infections in humans. Negative results do not preclude HPIV-1, HPIV-2, HPIV-3, and HPIV-4 infections and should not be used as the sole basis for treatment or other management decisions. This assay is designed for use on the Panther Fusion system.

Source page: https://510kreport.com/device/K172282
Methodology: https://510kreport.com/methodology