# K163628: Idylla Respiratory (IFV-RSV) Panel

- Pathway: 510(k) (Traditional)
- Applicant: Janssen Pharmaceutica NV
- Decided: Aug 30, 2017 after 251 days
- Product code: OCC (Respiratory Virus Panel Nucleic Acid Assay System)
- Device class: 2
- Regulation: 21 CFR 866.3980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN070013 (2008). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103209: Verigene Respiratory Virus Nucleic Acid Test +(Rvnat+), Nanosphere, Inc. (2011) Summary page 5.

## Indications for use
The Idylla Respiratory (IFV-RSV) Panel is an in vitro assay intended for the qualitative detection of nucleic acids for Influenza A, Influenza A subtype H1, Influenza A subtype H3, Influenza A subtype 2009 H1, H275Y mutation of Influenza A subtype 2009 H1, Influenza B and Respiratory Syncytial Virus (A and B) from nasopharyngeal swabs in viral transport media of adult and pediatric patients. The test uses the Idylla system to aid in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. Negative results do not preclude respiratory virus infection or co-infection with other viruses and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Performance characteristics for Influenza A were established when influenza A/2009 H1 and H3 were the predominant influenza A viruses in circulation. When other Influenza A viruses are emerging, performance characteristics may vary. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing. Viral culture should not be attempted in these cases unless a BSL3+ facility is available to receive and culture specimens.

Source page: https://510kreport.com/device/K163628
Methodology: https://510kreport.com/methodology