# K024113: Ivd Crypto/Giardia Dfa

- Pathway: 510(k) (Traditional)
- Applicant: Ivd Research, Inc.
- Decided: Mar 5, 2003 after 82 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 K912408 (1991). 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)
- K912408: Merifluor-Cryptosporidium/Giardia, Meridian Diagnostics, Inc. (1991) Summary page 1.

## Indications for use
This direct fluorescent antigen (DFA) detection kit is an in vitro diagnostic (IVD) immunoassay for the detection of Cryptosporidium oocysts and Giardia Cysts in human feces using fluorescent microscopic visualization. This IVD assay is intended to be used with stools preserved in 10% formalin, SAF or Medical Chemical Corporation’s (MCC’s ) Universal fixative. Such samples may be concentrated or unconcentrated.

Source page: https://510kreport.com/device/K024113
Methodology: https://510kreport.com/methodology