510(k) Report

510(k) · Cleared

Cleared

Aeskulisa Asca a

K051492510(k) TraditionalCleared Nov 14, 2005161-day reviewClass II21 CFR 866.5785

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Aesku, Inc. · NBT Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)

Cleared on Nov 14, 2005 after a 161-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Nov 14, 2005
Review
161 days
Class
Class II
Product code
NBT
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K051492Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

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 devices

NBT Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NBT

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

AESKULISA ASCA-A is a solid phase enzyme immunoassay (ELISA) employing purified mannan for the semi-quantitative and qualitative detection of IgA anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specifically mannan, a component of the outer cell wall of yeast. The AESKULISA ASCA A kit should not be used as a screening test for ASCA, since some Crohn's disease patients do not have ASCA IgA antibodies. The AESKULISA ASCA A kit…

Read the full statement (176 words)

AESKULISA ASCA-A is a solid phase enzyme immunoassay (ELISA) employing purified mannan for the semi-quantitative and qualitative detection of IgA anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specifically mannan, a component of the outer cell wall of yeast.

The AESKULISA ASCA A kit should not be used as a screening test for ASCA, since some Crohn's disease patients do not have ASCA IgA antibodies. The AESKULISA ASCA A kit should be used to compliment, but not to replace or to substitute for ASCA IgG antibody testing. The assay is an aid in the diagnosis of Crohn's disease and should be used in conjunction with other serological tests and clinical findings.

AESKULISA ASCA-G is a solid phase enzyme immunoassay (ELISA) employing purified mannan for the semi-quantitative and qualitative detection of lgG anti-Saccharomyces cerevisiae antibodies (ASCA) in human serum. ASCA recognize specific mannan, a component of the outer cell wall of yeast. The assay is an aid in the diagnosis of Crohn's disease and should be used in conjunction with other serological tests and clinical findings.

Indications for use as stated in the FDA 510(k) statement.

More from Aesku, Inc.

6 FDA decisions under this applicant name. See the company

  • K062217Aeskulska BETA2-Glyco-aAesku, Inc. · 2006
  • K042644Aeskulisa TTG a and Aeskulisa TTG GAesku, Inc. · 20051 recall
  • K040953Aeskulisa Ana Hep-2Aesku, Inc. · 2004
  • K040463Aeskulisa Cardiolipin AgmAesku, Inc. · 2004
  • K032469Aeskulisa Ana 8PROAesku, Inc. · 2003

Recent decisions in NBT

The NBT category page

  • K071711Asca-ChekTechlab Inc., Corporate Research Center · 2007
  • K051927Techlab Asca-ChekTechlab, Inc. · 2006
  • K042579Bindazyme Human Asca Igg and Iga Eia Diagnostic Test KitThe Binding Site · 2005
  • K032850Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Igg)Immco Diagnostics, Inc. · 2004
  • K032860Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Iga)Immco Diagnostics, Inc. · 2004

https://510kreport.com/device/K051492 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051492: Aeskulisa Asca a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051492

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026