# K190204: ID NOW Influenza A & B 2

- Pathway: 510(k) (Special)
- Applicant: Alere Scarborough, Inc.
- Decided: Mar 18, 2019 after 42 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: 11 generations back to DEN070013 (2008). 22 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173932: Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2, Alere Scarborough, Inc. (2018) Summary page 4.

## Most influential descendants
- K191534: ID NOW Influenza A & B 2 (2019), 0 descendants of its own

## Indications for use
The ID NOW Influenza A & B 2 assay performed on the ID NOW 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 or nasopharyngeal 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. 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/K190204
Methodology: https://510kreport.com/methodology