510(k) · Cleared
ClearedBindazyme Human Asca Igg and Iga Eia Diagnostic Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Binding Site · NBT Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
Cleared on Jul 28, 2005 after a 309-day review. The FDA summary names no predicate by number.
- Decided
- Jul 28, 2005
- Review
- 309 days
- Class
- Class II
- Product code
- NBT
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 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?
The FDA summary names no predicate by number.
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.
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?
This assay is intended for the in vitro semi-quantitative measurement of ASCA IgA anti-Saccharomyces cerevisiae antibody in human serum. The presence of ASCA may aid in the diagnosis of patients with Crohn's disease. The test results should be used in conjunction with clinical findings and other laboratory tests. The ASCA IgA should not be used alone as a screening test for ASCA. ASCA IgA test should be used to complement, but not to replace or to substitute the ASCA IgG antibody test since some Crohn's disease subgroup patients may not have IgA antibodies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042579 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042579: Bindazyme Human Asca Igg and Iga Eia Diagnostic Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042579
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026