# K110722: RPS Adeno Detector Plus

- Pathway: 510(k) (Traditional)
- Applicant: Rapid Pathogen Screening, Inc.
- Decided: May 17, 2011 after 63 days
- Product code: GOD (Antigens, Cf (Including Cf Control), Adenovirus 1-33)
- Device class: 1
- Regulation: 21 CFR 866.3020
- 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 K990630 (1999). 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)
- K052092: RPS Adeno Detector, Rapid Pathogen Screening (2005) Summary page 1.

## Indications for use
The RPS Adeno Detector Plus is a rapid immunoassay test for the visual, qualitative in-vitro detection of Adenoviral antigens (hexon protein) directly from human eye fluid. The test is intended for use as an aid in the rapid differential diagnosis of acute conjunctivitis. Negative results do not preclude Adenovirus infection nor are they intended to rule out other microbial-caused infections of the conjunctiva, and should not be used as the sole basis for treatment or other management decisions.

Source page: https://510kreport.com/device/K110722
Methodology: https://510kreport.com/methodology