# K120946: Alpha Cryptococcal Antigen Eia

- Pathway: 510(k) (Traditional)
- Applicant: Immuno-Mycologics, Inc.
- Decided: Dec 17, 2012 after 263 days
- Product code: MDU (Antigen, Elisa, Cryptococcus)
- Device class: 2
- Regulation: 21 CFR 866.3165
- 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 K904393 (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)
- K904393: Premier-Cryptococcal Antigen, Meridian Diagnostics, Inc. (1991) Summary page 1.

## Indications for use
The ALPHA Cryptococcal Antigen enzyme immunoassay (CrAg EIA) is a qualitative or semi-quantitative (titration) test system for the detection of capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gattii) in serum and cerebrospinal fluid (CSF). The ALPHA Cryptococcal Antigen Enzyme Immunoassay is an assay which can be used as an aid in the diagnosis of cryptococcosis. Test results are to be used in conjunction with information available from the patient clinical evaluation and other diagnostic procedures.

Source page: https://510kreport.com/device/K120946
Methodology: https://510kreport.com/methodology