# K033274: Giardia II

- Pathway: 510(k) (Special)
- Applicant: Techlab, Inc.
- Decided: Nov 4, 2003 after 25 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K103673: Giardia/ Cryptosporidium Quik Chek (2011), 0 descendants of its own

## Indications for use
The GIARDIA I1 test is an enzyme immunoassay for the qualitative detection of Giardia iambiia cyst antigen in human fecal specimens. It is indicated for use with fecal specimens from patients with diarrhea to determine the presence of G. lamblia gastrointestinal infection. This test can be used for fecal specimens submitted for routine clinical testing from adults or children. FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K033274
Methodology: https://510kreport.com/methodology