# K112422: Crag Lateral Flow Assay (Lfa)

- Pathway: 510(k) (Traditional)
- Applicant: Immuno-Mycologics, Inc.
- Decided: Mar 28, 2012 after 218 days
- Product code: GMD (Antisera, Latex Agglutination, Cryptococcus Neoformans)
- Device class: 2
- Regulation: 21 CFR 866.3165
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K791382 (1979). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102286: Crag Lateral Flow Assay (Crag Lfa), Immuno-Mycologics, Inc. (2011) Summary page 1.

## Recalls of this device
- Jan 3, 2022 · Class II · Z-0545-2022: The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospinal fluid to have reduced specificity (90% now versus 99% before). As a result, a small number of samples
- Mar 30, 2018 · Class II · Z-2409-2018: Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results
- Dec 27, 2016 · Class II · Z-1109-2017: The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who reported false positive 

## 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 Cryptacoccus species complex (Cryptococcus neafarmans and Cryptacaccus gatti) in serum and cerebral spinal fluid (CSF). 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/K112422
Methodology: https://510kreport.com/methodology