# K052092: RPS Adeno Detector

- Pathway: 510(k) (Traditional)
- Applicant: Rapid Pathogen Screening
- Decided: Nov 22, 2005 after 112 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: 1 generation back to K990630 (1999). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990630: Sas Adeno Test, Sa Scientific, Inc. (1999) Summary page 1.

## Most influential descendants
- K110722: RPS Adeno Detector Plus (2011), 0 descendants of its own

## Indications for use
The RPS Adeno Detector is a rapid immunochromatography test for 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 adenoviral conjunctivitis. All negative test results should be confirmed by cell culture.

Source page: https://510kreport.com/device/K052092
Methodology: https://510kreport.com/methodology