# K163266: Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument

- Pathway: 510(k) (Special)
- Applicant: Alere Scarborough, Inc.
- Decided: Dec 21, 2016 after 30 days
- Product code: OCC (Respiratory Virus Panel Nucleic Acid Assay System)
- 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: 8 generations back to DEN070013 (2008). 11 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151464: Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit, Alere Scarborough, Inc. (2015) Summary page 4.

## Most influential descendants
- K171792: Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit (2017), 6 descendants of its own
- K173932: Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 (2018), 3 descendants of its own
- K220801: ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 (2022), 2 descendants of its own
- K232775: ID NOW Influenza A & B 2 (2023), 1 descendant of its own
- K190204: ID NOW Influenza A & B 2 (2019), 1 descendant of its own

## Indications for use
The Alere™ i Influenza A & B assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in direct nasal swabs and nasal or nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in humans 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 diagnosis, treatment or other patient management decisions. Performance characteristics for influenza A were established during the 2012-2013 and the 2014-2015 influenza seasons when influenza A/H3 and A/H1N1 pandemic 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 and culture specimens.

Source page: https://510kreport.com/device/K163266
Methodology: https://510kreport.com/methodology