# K091053: Proparaflu+Assay

- Pathway: 510(k) (Traditional)
- Applicant: Prodesse, Inc.
- Decided: Nov 20, 2009 after 221 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: 1 generation back to DEN070013 (2008). 1 ancestor in all.
4 later devices descend from it; 3 cite 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)
- DEN070013: ID-Tag Respiratory Viral Panel, Luminex Molecular Diagnostics, Inc. (2008). Our reading of the summary gave K063765, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN070013, ID-Tag Respiratory Viral Panel (Luminex Molecular Diagnostics, Inc.), granted Jan 3, 2008; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K132238: Proparaflu+ Assay (2013), 2 descendants of its own
- K153223: ProParaFlu+ Assay (2015), 1 descendant of its own
- K172282: Panther Fusion Paraflu Assay (2017), 0 descendants of its own
- K141927: Lyra Parainfluenza Virus Assay (2014), 0 descendants of its own

## Indications for use
The ProParaflu+ Assay is a multiplex Real Time RT-PCR in vitro diagnostic test for the qualitative detection and discrimination of Parainfluenza 1 Virus, Parainfluenza 2 Virus and Parainfluenza 3 Virus (HPIV-1, HPIV-2 and HPIV-3) nucleic acids isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections. This assay targets the conserved regions of the Hemagglutinin-Neuraminidase (HN) gene of HPIV-1, HPIV-2 and HPIV- 3, respectively. The detection and discrimination of HPIV-1, HPIV-2 and HPIV-3 nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract parainfluenza infections if used in conjunction with other clinical and laboratory findings. This test is not intended to detect Parainfluenza 4a or Parainfluenza 4b Viruses. Negative test results are presumptive and should be confirmed by cell culture. Negative results do not preclude Parainfluenza 1,2 or 3 virus infections and should not be used as the sole basis for treatment or other management decisions.

Source page: https://510kreport.com/device/K091053
Methodology: https://510kreport.com/methodology