# K021172: RSV Oia

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Biostar, Inc.
- Decided: Sep 13, 2002 after 154 days
- Product code: GOG (Antisera, Cf, Poliovirus 1-3)
- Device class: 1
- Regulation: 21 CFR 866.3405
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K902609 (1990). 3 ancestors in all.
3 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)
- K981651: AB Flu Oia, Biostar, Inc. (1998) Summary page 1.
- K882629: Directigen Respiratory Syncytial Virus Test Kit, Bd Becton Dickinson Vacutainer Systems Preanalytic (1988) Summary page 1.

## Most influential descendants
- K023779: RSV Oia (2003), 2 descendants of its own
- 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 BioStarTMRSV OIAO assay is an Optical Immunoassay (OIA) test for the qualitative, rapid detection of respiratory syncytial virus antigens (nucleoprotein and fusion protein) from nasal wash specimens. This test is intended for in vitro diagnostic use to aid in the diagnosis of respiratory syncytial virus 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/K021172
Methodology: https://510kreport.com/methodology