510(k) · Cleared
ClearedImmulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Igg)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immco Diagnostics, Inc. · NBT Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
Cleared on Mar 18, 2004 after a 188-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Mar 18, 2004
- Review
- 188 days
- Class
- Class II
- Product code
- NBT
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK032850 Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Igg)Immco Diagnostics, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK051927 Techlab Asca-ChekTechlab, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K051927Techlab Asca-ChekTechlab, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032850 | Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Igg) | Immco Diagnostics, Inc. | 2004 | — |
| +1 | K051927 | Techlab Asca-Chek | Techlab, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NBT? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K051927 | Techlab Asca-Chek | 2006 | 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?
- Of its descendants, K051927 (Techlab, Inc., 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NBT devicesNBT Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NBT
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · NBT
Too few NBT 510(k)s in any year since 2007 to give a median.
Recalls per year · NBT
No recall names NBT since 2007.
Adverse event reports per year · NBT
No MAUDE report names NBT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 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?
An enzyme linked immunosorbent assay (ELISA) for the detection and semi-quantitation of anti-Saccharomyces cerevisiae IgG antibodies in human serum of patients with inflammatory bowel disorder (IBD) as an aid in the diagnosis of Crohn's disease (CD).
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K032850 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032850: Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Igg).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032850
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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