# K141520: Alere I Influenza a & B

- Pathway: 510(k) (Traditional)
- Applicant: Alere Scarborough, Inc D/B/A Binax, Inc.
- Decided: Jun 13, 2014 after 4 days
- Product code: OCC (Respiratory Virus Panel Nucleic Acid Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3980
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN070013 (2008). 9 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111387: Liat (TM) Influenza a / B Assay, Liat (TM) Analyzer, Iquum, Inc. (2011) Summary page 1.

## Most influential descendants
- K151464: Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab Kit (2015), 8 descendants of its own
- K163266: Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument (2016), 7 descendants of its own
- K171792: Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit (2017), 6 descendants of its own
- K151690: Alere i Instrument, Alere i Influenza A & B, Alere i Strep A (2015), 4 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

## Recalls of this device
- Jan 25, 2017 · Class II · Z-1231-2017: Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incorrect sample swab mixed in with the proper swabs.
- Jun 26, 2015 · Class II · Z-2095-2015: Risk of false negative results due to microbial growth in the Sample Receiver of one lot of the Alere i Influenza A & B kit
- Apr 22, 2015 · Class II · Z-1677-2015: High invalid rate and an increased risk of false negative results with certain lots of the Alere i Influenza A & B kit.

## Indications for use
The Alere'~' I Influenza A & B assay performed on the AlereTh 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 nasal swabs 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 20 12-2013 influenza season when influenza A/H-3 and A/MINI pandemnic 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/K141520
Methodology: https://510kreport.com/methodology