# K023779: RSV Oia

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Biostar, Inc.
- Decided: Jan 14, 2003 after 63 days
- Product code: GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus)
- Device class: 1
- Regulation: 21 CFR 866.3480
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K902609 (1990). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021172: RSV Oia, Thermo Biostar, Inc. (2002)

## Most influential descendants
- K041445: Immunocard Stat! RSV Model #750630 (2004), 1 descendant of its own
- K071101: Tru RSV (2007), 0 descendants of its own

## Indications for use
The Thermo BioStar RSV OIA assay is an Optical ImmunoAssay test for the rapid and qualitative detection of respiratory syncytial virus (RSV) antigens (nucleoproteins and fusion proteins) from nasal wash and nasopharyngeal swab specimens. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in symptomatic neonatal and pediatric patients under the age of five. It is recommended that all negative test results be confirmed by cell culture.

Source page: https://510kreport.com/device/K023779
Methodology: https://510kreport.com/methodology