# K171963: Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Sep 26, 2017 after 88 days
- Product code: OCC (Respiratory Virus Panel Nucleic Acid Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3980
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to DEN070013 (2008). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153219: ProFlu+ Assay, Hologic, Inc. (2015) Summary page 4.

## Recalls of this device
- Oct 10, 2019 · Class II · Z-2163-2020: Reagent component included in flu test kit may cause both high background signal in a true negative sample leading to false positive and/or false negative results. This could result in false positive 

## Indications for use
The Panther Fusion Flu A/B/RSV assay is a multiplex real-time PCR (RT-PCR) in vitro diagnostic test for the rapid and qualitative detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV). 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 influenza A virus, influenza B virus and RSV infections in humans and is not intended to detect influenza C virus infections. Negative results do not preclude influenza A virus, influenza B virus or RSV 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. Performance characteristics for influenza A were established when influenza A(H3N2) and A(H1N1)pdm09 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary. If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive any culture specimens.

Source page: https://510kreport.com/device/K171963
Methodology: https://510kreport.com/methodology