# K031965: Xpect Cryptosporidium Lateral Flow Assay, Model 2451020

- Pathway: 510(k) (Traditional)
- Applicant: Remel, Inc.
- Decided: Nov 14, 2003 after 141 days
- Product code: MHJ (Cryptosporidium 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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
- K121565: Uni-Gold Cryptosporidium (2013), 0 descendants of its own

## Recalls of this device
- May 9, 2002 · Not classified · Z-1376-04: A potential stability problem has been identified with the Positive Controls in the referenced kit lots of the ProSpecT Cryptosporidium Microplate Assay. The Positive Control may NOT perform as intend

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

Source page: https://510kreport.com/device/K031965
Methodology: https://510kreport.com/methodology