# K141931: Lyra Adenovirus Assay

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corporation
- Decided: Oct 9, 2014 after 85 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121942: Adenovirus R-Gene US, Argene SA (2013) Summary page 5.

## Indications for use
The Lyra™ Adenovirus Assay is a real‐time polymerase chain reaction (PCR) in vitro diagnostic test for the qualitative detection of human adenovirus (HAdV) viral DNA isolated from nasal and nasopharyngeal swab specimens obtained from individuals exhibiting signs and symptoms of acute respiratory infections. The intended use of this test is to aid in the diagnosis of HAdV in conjunction with other clinical and laboratory findings. The test detects, but does not differentiate, HAdV species (A, B, C, D, E, and F) or serotypes (HAdV 1-52). Negative results do not preclude HAdV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.

Source page: https://510kreport.com/device/K141931
Methodology: https://510kreport.com/methodology