# K983399: Giardia/Cryptosporidium Combo Rapid Assay

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Diagnostics
- Decided: Jan 11, 1999 after 105 days
- Product code: MHI (Giardia Spp.)
- Device class: 2
- Regulation: 21 CFR 866.3220
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Alexon ProSpecT: named in the summary without a submission number

## Most influential descendants
- K031942: Xpect Giardia Lateral Flow Assay, Model 2450020 (2003), 2 descendants of its own
- K031965: Xpect Cryptosporidium Lateral Flow Assay, Model 2451020 (2003), 1 descendant of its own
- K120001: Unigold Giardia (2013), 0 descendants of its own
- K121565: Uni-Gold Cryptosporidium (2013), 0 descendants of its own
- K081064: Giardia Fecal Antigen Detection Lateral Flow Kit, Model GL-LF (2009), 0 descendants of its own

## Recalls of this device
- Mar 24, 2025 · Class II · Z-1719-2025: A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements.
- Feb 23, 2004 · Not classified · Z-0770-04: False Positive results.

## Indications for use
This is an immunochromatographic assay for the simultaneous qualitative detection and distinguishing of Giardia and Cryptosporidium specific antigens in aqueous extracts of fecal specimens. It is intended for professional laboratory use.

Source page: https://510kreport.com/device/K983399
Methodology: https://510kreport.com/methodology