# K031942: Xpect Giardia Lateral Flow Assay, Model 2450020

- Pathway: 510(k) (Traditional)
- Applicant: Remel, Inc.
- Decided: Nov 18, 2003 after 147 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: 1 generation back to K983399 (1999). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983399: Giardia/Cryptosporidium Combo Rapid Assay, Genzyme Diagnostics (1999) Summary page 1.

## Most influential descendants
- K120001: Unigold Giardia (2013), 0 descendants of its own
- K081064: Giardia Fecal Antigen Detection Lateral Flow Kit, Model GL-LF (2009), 0 descendants of its own

## Indications for use
REMEL's Xpect™Giardia kit is an in vitro qualitative immunoassay for the detection of Giardia antigens in preserved and unpreserved fecal specimens. This test is intended as an aid in the laboratory diagnosis of suspected Giardia infections.

Source page: https://510kreport.com/device/K031942
Methodology: https://510kreport.com/methodology