510(k) · Cleared
Recalled · Class II · 2022Crag Lateral Flow Assay (Lfa)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immuno-Mycologics, Inc. · GMD Antisera, Latex Agglutination, Cryptococcus Neoformans
Cleared on Mar 28, 2012 as substantially equivalent to K102286 (Immuno-Mycologics, Inc., 2011) after a 218-day review. Its family tree reaches back 2 generations to 1979. It has been recalled 3 times.
- Decided
- Mar 28, 2012
- Review
- 218 days
- Class
- Class II
- Product code
- GMD
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K791382 (1979). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GMD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K102286 | Crag Lateral Flow Assay (Crag Lfa)Summary page 1…y Common Name: Cryptococcal Antigen Lateral Flow Immunoassay Regulation: 866.3165 Predicate Device: Immuno-Mycologics' CrAg Lateral Flow Assay (K102286) Intended Use: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualita… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 3, 2022 | Class II | Z-0545-2022 | Material/Component Contamination | 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 with positive test results may be… |
| Mar 30, 2018 | Class II | Z-2409-2018 | Nonconforming Material/Component | Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test results |
| Dec 27, 2016 | Class II | Z-1109-2017 | Material/Component Contamination | 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 results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 33 years and passes through 1 company; a new generation was cleared every 31.9 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All GMD devicesGMD Antisera, Latex Agglutination, Cryptococcus Neoformans: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · GMD
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · GMD
Too few GMD 510(k)s in any year since 2007 to give a median.
Recalls per year · GMD
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GMD
1in 2017
MAUDE reports naming product code GMD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112422 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112422: Crag Lateral Flow Assay (Lfa).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112422
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026