# K955157: Prospect Giardia/Cryptosporidium Microplate Assay

- Pathway: 510(k) (Traditional)
- Applicant: Alexon Biomedical, Inc.
- Decided: Feb 9, 1996 after 88 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.
2 later devices descend 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K051929: Giardia/Cryptosporidium Chek (2005), 1 descendant of its own
- K171078: Tri-Combo Parasite Screen (2017), 0 descendants of its own

## Recalls of this device
- Dec 9, 2003 · Not classified · Z-1375-04: The conjugate may cause the negative control to produce high OD readings, therefore invalidating the run.
- Nov 21, 2002 · Not classified · Z-1374-04: The conjugate of the ProSpecT Giardia/Cryptosporidium Microplate Assay, Lot #926230, may have become contaminated during filling. The particulates in the contamination may cause the dropper tips to be

Source page: https://510kreport.com/device/K955157
Methodology: https://510kreport.com/methodology