510(k) · Cleared
ClearedCrag Lateral Flow Assay (Crag 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 Jul 20, 2011 as substantially equivalent to K791382 (Immuno-Mycologics, Inc., 1979) after a 342-day review. Its family tree reaches back 1 generation to 1979. 1 later device descends from it.
- Decided
- Jul 20, 2011
- Review
- 342 days
- Class
- Class II
- Product code
- GMD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K791382 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK791382 Cryptococcal Antigen Latex AgglutinationImmuno-Mycologics, Inc. · 1979
- This deviceK102286 Crag Lateral Flow Assay (Crag Lfa)Immuno-Mycologics, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK112422 Crag Lateral Flow Assay (Lfa)Immuno-Mycologics, Inc. · 2012 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K112422Crag Lateral Flow Assay (Lfa)Immuno-Mycologics, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K791382 | Cryptococcal Antigen Latex Agglutination | Immuno-Mycologics, Inc. | 1979 | — |
| 0 (this device) | K102286 | Crag Lateral Flow Assay (Crag Lfa) | Immuno-Mycologics, Inc. | 2011 | — |
| +1 | K112422 | Crag Lateral Flow Assay (Lfa) | Immuno-Mycologics, Inc. | 2012 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
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 |
|---|---|---|---|
| * | K791382 | Cryptococcal Antigen Latex AgglutinationSummary page 1…mmunoiassay Regulation: 866.3165 Predicate Device: Immuno-Mycologics' Latex-Cryptococcus Antigen Detection System 510(k) #IK791382I Intended Use: The CrAg Lateral Flow Assay isan immunochromatographic test system for the qu… | 1979 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112422 | Crag Lateral Flow Assay (Lfa) | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K112422 (Immuno-Mycologics, Inc., 2012) has gone furthest, with 0 descendants of its own.
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. 2011, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102286 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102286: Crag Lateral Flow Assay (Crag Lfa).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102286
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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