# K132159: Proadeno+ Assay

- Pathway: 510(k) (Special)
- Applicant: Gen-Probe Prodesse, Inc.
- Decided: Aug 14, 2013 after 33 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.
No later device cites it as a predicate yet.
0 of 5 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 1.

## Indications for use
The Prodesse® ProAdeno®+ Assay is a multiplex Real Time PCR in vitro diagnostic test for the qualitative detection of human Adenovirus (HAdV) DNA isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of acute respiratory infection. This test is intended for use to aid in the diagnosis of I-Ady infections in humans in conjunction with other clinical and laboratory findings. The test detects, but does not differentiate, serotypes 1-5 1. Negative results do not preclude HAdV infection and should not be used as the sole basis for treatment or other patient management decisions.

Source page: https://510kreport.com/device/K132159
Methodology: https://510kreport.com/methodology