# K161375: Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit

- Pathway: 510(k) (Traditional)
- Applicant: Alere Scarborough, Inc.
- Decided: Aug 18, 2016 after 92 days
- Product code: OCC (Respiratory Virus Panel Nucleic Acid Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3980
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN070013 (2008). 8 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131813: Quidel Molecular RSV + HMPV Assay, Quidel Corp. (2013) Summary page 4.

## Most influential descendants
- 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
- K190204: ID NOW Influenza A & B 2 (2019), 1 descendant of its own
- K262747: ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 (2026), 0 descendants of its own
- K191534: ID NOW Influenza A & B 2 (2019), 0 descendants of its own

## Recalls of this device
- Mar 4, 2025 · Class II · Z-1573-2025: The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
- Mar 4, 2025 · Class II · Z-1576-2025: the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.

## Indications for use
The Alere™ i RSV 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 of respiratory syncytial virus (RSV) viral RNA in direct nasopharyngeal swabs and 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 diagnosis of RSV in children <18 years and adults ≥60 years in conjunction with clinical and epidemiological risk factors.

Source page: https://510kreport.com/device/K161375
Methodology: https://510kreport.com/methodology