# K171641: Accula Flu A/Flu B Test

- Pathway: 510(k) (Dual Track)
- Applicant: Mesa Biotech, Inc.
- Decided: Feb 6, 2018 after 249 days
- Product code: OZE (Influenza A And Influenza B 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: 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)
- K141520: Alere I Influenza a & B, Alere Scarborough, Inc D/B/A Binax, Inc. (2014) Summary page 4.

## Indications for use
The Accula Flu A/Flu B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection and differentiation of influenza A and influenza B viral RNA. The Accula Flu A/Flu B Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection. The Accula Flu A/Flu B assay is intended as an aid in the diagnosis of influenza infection in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2016-2017 influenza season. 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 and culture specimens.

Source page: https://510kreport.com/device/K171641
Methodology: https://510kreport.com/methodology