510(k) · Cleared
ClearedAlpha Cryptococcal Antigen Eia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immuno-Mycologics, Inc. · MDU Antigen, Elisa, Cryptococcus
Cleared on Dec 17, 2012 as substantially equivalent to K904393 (Meridian Diagnostics, Inc., 1991) after a 263-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Dec 17, 2012
- Review
- 263 days
- Class
- Class II
- Product code
- MDU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K904393 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK904393 Premier-Cryptococcal AntigenMeridian Diagnostics, Inc. · 1991 · Recalled
- This deviceK120946 Alpha Cryptococcal Antigen EiaImmuno-Mycologics, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904393 | Premier-Cryptococcal Antigen | Meridian Diagnostics, Inc. | 1991 | 1 |
| 0 (this device) | K120946 | Alpha Cryptococcal Antigen Eia | Immuno-Mycologics, Inc. | 2012 | — |
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 MDU? 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 |
|---|---|---|---|
| * | K904393 | Premier-Cryptococcal AntigenSummary page 1…tigen ETA Classification Name: Antigen, Elisa, Cryptococcus Regulation: 866.3165 Predicate Device: Meridian's PremierM Cryptococcal Antigen ETA, K904393 Intended Use: The ALPHA Cryptococcal Antigen enzyme immunoassay (CrAg ETA) is a qualitativ… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
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 a recall.
How does its category compare?
All MDU devicesMDU Antigen, Elisa, Cryptococcus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MDU
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · MDU
Too few MDU 510(k)s in any year since 2007 to give a median.
Recalls per year · MDU
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MDU
No MAUDE report names MDU since 2007.
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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 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 | 0 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120946 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120946: Alpha Cryptococcal Antigen Eia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120946
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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