# MHJ: Cryptosporidium Spp.

- Device class: 2; regulation: 21 CFR 866.3220; FDA's rule: 510(k) exempt
- FDA decisions: 15
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1991: 1
- 1992: 1
- 1994: 1
- 1996: 3
- 1998: 3
- 2003: 2
- 2005: 2
- 2013: 1
- 2017: 1

## Most-cited predicates
- K955345: LMD Cryptosporidium Antigen Detection (1996), cited by 1
- K052932: Cryptosporidium II (2005), cited by 1
- K031965: Xpect Cryptosporidium Lateral Flow Assay, Model 2451020 (2003), cited by 1
- K051929: Giardia/Cryptosporidium Chek (2005), cited by 1

Source page: https://510kreport.com/product-code/MHJ
Data by year (CSV): https://510kreport.com/product-code/MHJ.csv