# K113323: Artus Infl a/B RG RT-PCR Kit

- Pathway: 510(k) (Traditional)
- Applicant: QIAGEN GmbH
- Decided: Feb 6, 2012 after 88 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: 5 generations back to DEN070013 (2008). 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)
- K110968: Proflu+ Assay, Gen-Probe Prodesse, Inc. (2011) Summary page 4.

## Indications for use
The artus®Infi AIB RG RT-PCR Kit is a multiplex real time PCR in vitro diagnostic test for the qualitative detection and identification of Influenza A and Influenza B virus RNA in nasopharyngeal swab specimens using the Rotor-Gene® Q MDx instrument. The test is intended for use as an aid in the differential diagnosis of Influenza A and Influenza B viral infections in patients symptomatic for respiratory tract infection in conjunction with clinical and epidemiological risk factors. It is not intended to detect Influenza C virus. Negative results do not preclude respiratory virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions. Performance characteristics for Influenza A were established during the 2009/20 10 and 2010/2011 flu seasons when Influenza A (113N2) and Influenza A/2009 (HINi) were the predominant Influenza A viruses in circulation. When other Influenza A viruses emerge, 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 BSL 3+ facility is available to receive and culture specimens.

Source page: https://510kreport.com/device/K113323
Methodology: https://510kreport.com/methodology