# K983336: Pathodx Respiratory Virus Panel Model PKRP1

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Mar 18, 1999 after 176 days
- Product code: LKT (Respiratory Syncytial Virus, Antigen, Antibody, Ifa)
- 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: 1 generation back to K896635 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896635: Viral Respiratory Indirect Fluores. Mono. Antibody, Baxter Healthcare Corp (1990) Summary page 1.
- K922801: Resp. Panel 1 Indirect Immunofluorescence Assay, Light Diagnostics (1993) Summary page 1.

## Indications for use
The PathoDx Respiratory Virus Panel (RVP) kit is a direct immunofluorescence test for the qualitative detection of 7 common respiratory viruses (respiratory syncytial virus, influenza A, influenza B, parainfluenza viruses 1,2, and 3, and adenovirus) in prepared direct patient specimens and following growth in cell culture. The materials supplied are intended for in vifro use only.

Source page: https://510kreport.com/device/K983336
Methodology: https://510kreport.com/methodology