# K071101: Tru RSV

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Bioscience, Inc.
- Decided: Oct 18, 2007 after 182 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: 5 generations back to K902609 (1990). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041445: Immunocard Stat! RSV Model #750630, Meridian Bioscience, Inc. (2004) Summary page 1.

## Indications for use
TRU RSV is a rapid, qualitative, lateral-flow immunoassay for the detection of Respiratory Syncytial Virus (RSV) antigens (fusion protein or nucleoprotein) in human nasal wash, nasopharyngeal aspirate and nasal and nasopharyngeal swab samples. It is designed to test specimens from symptomatic patients aged 5 years or less. A negative result does not preclude RSV infection. It is recommended that all negative test results be confirmed by cell culture.

Source page: https://510kreport.com/device/K071101
Methodology: https://510kreport.com/methodology