# K990630: Sas Adeno Test

- Pathway: 510(k) (Traditional)
- Applicant: Sa Scientific, Inc.
- Decided: Aug 19, 1999 after 174 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
No predicates in its family tree.
2 later devices descend 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)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K052092: RPS Adeno Detector (2005), 1 descendant of its own
- K110722: RPS Adeno Detector Plus (2011), 0 descendants of its own

## Indications for use
The SAS™ Adeno Test is a membrane-based immunogold assay for the detection of adenovirus and adenovirus antigens. The test is a rapid visual test for the qualitative detection of adenovirus serotypes present in eye swabs, nasal and pharyngeal secretions, fecal samples, and cell culture supernatant. This test is for professional use only.

Source page: https://510kreport.com/device/K990630
Methodology: https://510kreport.com/methodology