# K121942: Adenovirus R-Gene US

- Pathway: 510(k) (Traditional)
- Applicant: Argene SA
- Decided: Feb 8, 2013 after 221 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: 4 generations back to DEN070013 (2008). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102952: Prodesse Proadeno, Gen-Probe Prodesse, Inc. (2010) Summary page 3.

## Most influential descendants
- K141931: Lyra Adenovirus Assay (2014), 0 descendants of its own

## Indications for use
Adenovirus R-gene® US Assay is a Real Time PCR in vitro diagnostic test for the rapid and qualitative detection of Adenovirus viral DNA isolated and purified from nasopharyngeal swab or nasopharyngeal wash/aspirate specimens obtained from individuals exhibiting signs and symptoms of acute respiratory infection. The intended use for this test is to aid in the diagnosis of respiratory Adenovirus infection in humans in conjunction with other clinical and laboratory findings. The test detects, but does not differentiate, Adenovirus species (A, B, C, D, E, F and G). Negative results do not preclude Adenovirus infection and should not be used as the sole basis for treatment or other patient management decisions.

Source page: https://510kreport.com/device/K121942
Methodology: https://510kreport.com/methodology