# K081064: Giardia Fecal Antigen Detection Lateral Flow Kit, Model GL-LF

- Pathway: 510(k) (Traditional)
- Applicant: Ivd Research, Inc.
- Decided: Jan 14, 2009 after 275 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
Longest line of descent: 2 generations back to K983399 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031942: Xpect Giardia Lateral Flow Assay, Model 2450020, Remel, Inc. (2003) Summary page 2.

## Indications for use
The IVD Research, Inc. GiardiaFecal Antigen Detection Lateral Flow Kit is a qualitative immunoassay for the detection of Giardia antigens in preserved and unpreserved human fecal specimens. This test is indicated as an aid in the clinical laboratory diagnosis of suspected Giardia infections. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K081064
Methodology: https://510kreport.com/methodology