# K141927: Lyra Parainfluenza Virus Assay

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corporation
- Decided: Oct 9, 2014 after 85 days
- Product code: OOU (Parainfluenza Multiplex Nucleic Acid Assay)
- 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: 2 generations back to DEN070013 (2008). 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)
- K091053: Proparaflu+Assay, Prodesse, Inc. (2009) Summary page 5.

## Indications for use
The Lyra™ Parainfluenza Virus Assay is a Real‐Time PCR assay for the qualitative detection and identification of human parainfluenza virus types 1, 2 and 3 viral RNA from nasal and nasopharyngeal swab specimens from symptomatic patients. It is intended for use as an aid in the differential diagnosis of parainfluenza virus types 1, 2 and 3. This test is not intended to detect Parainfluenza 4a or Parainfluenza 4b viruses. Negative results do not preclude parainfluenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.

Source page: https://510kreport.com/device/K141927
Methodology: https://510kreport.com/methodology