# K904393: Premier-Cryptococcal Antigen

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Diagnostics, Inc.
- Decided: Jan 25, 1991 after 122 days
- Product code: MDU (Antigen, Elisa, Cryptococcus)
- Device class: 2
- Regulation: 21 CFR 866.3165
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K120946: Alpha Cryptococcal Antigen Eia (2012), 0 descendants of its own

## Recalls of this device
- Dec 17, 2018 · Class II · Z-0732-2019: An enzyme reagent included in the kit is not maintaining stability through claimed product expiration, resulting in the potential for false negative results when tested with patient specimens and the 

Source page: https://510kreport.com/device/K904393
Methodology: https://510kreport.com/methodology