# K031834: Xpect Giardia/Cryptosporidium Lateral Flow Assay

- Pathway: 510(k) (Traditional)
- Applicant: Remel, Inc.
- Decided: Nov 10, 2003 after 150 days
- Product code: MHI (Giardia Spp.)
- Device class: 2
- Regulation: 21 CFR 866.3220
- Recalls of this device: 1 (0 Class I)
- 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.
No later device cites it as a predicate yet.
0 of 2 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)

## Recalls of this device
- Aug 11, 2008 · Not classified · Z-2432-2008: Faint grey test lines for Cryptosporidium may be visible which may be interpreted as false positive

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

Source page: https://510kreport.com/device/K031834
Methodology: https://510kreport.com/methodology