# K041445: Immunocard Stat! RSV Model #750630

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Bioscience, Inc.
- Decided: Aug 13, 2004 after 73 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: 4 generations back to K902609 (1990). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032166: Binax Now RSV Test, Model 430-000 and Binax Now Nasopharyngeal Swab Accessory Pack, Model 400-065, Binax, Inc. (2003) Summary page 1.
- K022133: BD Directigen EZ RSV Kit, Becton, Dickinson & CO (2002) Summary page 1.
- K023779: RSV Oia, Thermo Biostar, Inc. (2003) Summary page 1.

## Most influential descendants
- K071101: Tru RSV (2007), 0 descendants of its own

## Indications for use
ImmunoCard STAT! RSV is a rapid, qualitative, lateral-flow immunoassay for the detection of Respiratory Syncytial Virus (RSV) antigens (fusion protein or internal protein) in human nasal wash, nasopharyngeal aspirate and nasal and nasopharyngeal swab samples. It is designed to test specimens from symptomatic neonatal and pediatric patients. It is recommended that all negative test results be confirmed by cell culture.

Source page: https://510kreport.com/device/K041445
Methodology: https://510kreport.com/methodology