# K020583: Ivd Giardia Antigen Detection Assay Model GL-96

- Pathway: 510(k) (Traditional)
- Applicant: Ivd Research, Inc.
- Decided: Sep 17, 2002 after 208 days
- Product code: MHI (Giardia Spp.)
- Device class: 2
- Regulation: 21 CFR 866.3220
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This ELISA is an in vitro immunoassay for the qualitative determination of Giardia antigen in feces. It is a double antibody (sandwich) ELISA using an anti-Giardia antibody to capture the antigen from the stool supernatant. A second anti-Giardia antibody is then added which sandwiches the captured antigen. This reaction is visualized by the addition of an anti-second antibody conjugated to peroxidase and the chromogen tetramethylbenzidine (TMB). The resulting blue color development indicates the presence of Giardia antigens being bound by the anti-Giardia antibodies.

Source page: https://510kreport.com/device/K020583
Methodology: https://510kreport.com/methodology