# K102286: Crag Lateral Flow Assay (Crag Lfa)

- Pathway: 510(k) (Traditional)
- Applicant: Immuno-Mycologics, Inc.
- Decided: Jul 20, 2011 after 342 days
- Product code: GMD (Antisera, Latex Agglutination, Cryptococcus Neoformans)
- 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 K791382 (1979). 1 ancestor in all.
1 later device descends 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)
- K791382: Cryptococcal Antigen Latex Agglutination, Immuno-Mycologics, Inc. (1979) Summary page 1.

## Most influential descendants
- K112422: Crag Lateral Flow Assay (Lfa) (2012), 0 descendants of its own

## Indications for use
The Cryptococcal Antigen Lateral Flow Assay (CrAg LFA) is an immunochromatographic test system for the qualitative or semi-quantitative detection of capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans and Cryptococcus gatti) in serum. The CrAg Lateral Flow Assay is a prescription-use laboratory assay, which can aid in the diagnosis of cryptococcosis.

Source page: https://510kreport.com/device/K102286
Methodology: https://510kreport.com/methodology