510(k) · Cleared
ClearedTechlab Asca-Chek
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techlab, Inc. · NBT Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
Cleared on Apr 6, 2006 as substantially equivalent to DEN000007 (Inova Diagnostics, Inc., 2000) and 3 other predicates after a 262-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Apr 6, 2006
- Review
- 262 days
- Class
- Class II
- Product code
- NBT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to DEN000007 (2000). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backDEN000007 Quanta Lite Asca (S. Cerevisiae) Igg ElisaInova Diagnostics, Inc. · 2000
- This deviceK051927 Techlab Asca-ChekTechlab, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN000007 | Quanta Lite Asca (S. Cerevisiae) Igg Elisa | Inova Diagnostics, Inc. | 2000 | — |
| 0 (this device) | K051927 | Techlab Asca-Chek | Techlab, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 2 | 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 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? (4)
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 |
|---|---|---|---|
| * | DEN000007 | Quanta Lite Asca (S. Cerevisiae) Igg Elisa Our reading of the summary gave K000732, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN000007, Quanta Lite Asca (S. Cerevisiae) Igg Elisa (Inova Diagnostics, Inc.), granted Aug 16, 2000; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2000 |
| * | K000733 | Quanta Lite Asca (S. Cerevisiae) Iga ElisaSummary page 1…romyces cerevisiae IgG antibodies (ASCA) in human serum as an aid for the differential diagnosis of Crohn's disease from ulcerative colitis. * QUANTA Lite TM ASCA IgA (K000733). This is an ELISA for the semi-quantitative detection of anti-Saccharomyces cerevisiae IgA antibodies (ASCA) in human serum… | 2001 |
| * | K032850 | Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Igg)Summary page 1…ASCA) in human serum as an aid for the differential diagnosis of Crohn's disease from ulcerative colitis. - ImmuLisa Anti-Saccharomyces cerevisiae Antibody (ASCA) IgG (K032850). An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of anti- Saccharomyces cerevisiae (IgG) in hum… | 2004 |
| * | K032860 | Immulisa Anti-Saccharomyces Cerevisiae Antibody (Asca) (Iga)Summary page 1…um of patients with inflammatory bowel disorder (IBD) as an aid in the diagnosis of Crohn's disease (CD). * ImmuLisa Anti-Saccharomyces cerevisiae Antibody (ASCA) IgA (K032860). An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of anti-Saccharomyces cerevisiae (IgA) in huma… | 2004 |
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?
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate DEN000007.
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?
The TECHLAB® ASCA-CHEK test is an ELISA for the qualitative detection of
human anti-S. cerevisiae antibodies (ASCA) in feces. The test result is used as an aid in
the diagnosis of Crohn's disease in combination with clinical and other laboratory
findings.
FOR IN VITRO DIAGNOSTIC USE.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051927 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051927: Techlab Asca-Chek.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051927
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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