# K972406: Adenovirus Antigen Detection Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Immunoprobe, Inc.
- Decided: Dec 22, 1997 after 179 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) cell culture of adenovirus from fecal samples: named in the summary without a submission number

## Indications for use
The Adenovirus Antigen Detection ELISA Test System is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of Adenovirus antigen in human fecal samples as an aid in the diagnosis of acute non-bacterial gastro-enteritis. Performance for this assay has not been established on children over the age of five and immunocompromised patients. The antibody utilized in this assay is a group specific antigen and cannot differentiate between types of adenovirus. Performance of this assay has not been established for specimens other than human feces.

Source page: https://510kreport.com/device/K972406
Methodology: https://510kreport.com/methodology