510(k) · Cleared
ClearedImmunocap/Unicap Gliadin Iga, Immunocap/Unicap Specific Iga, Models 14-4425-40, 10-9306-02
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmacia Diagnostics AB · MST Antibodies, Gliadin
Cleared on Feb 7, 2006 as substantially equivalent to K982533 (Pharmacia & Upjohn Co., 1998) after a 127-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Feb 7, 2006
- Review
- 127 days
- Class
- Class II
- Product code
- MST
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K982533 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK982533 Unicap Gliadin Iga AssayPharmacia & Upjohn Co. · 1998
- This deviceK052793 Immunocap/Unicap Gliadin Iga, Immunocap/Unicap Specific Iga, Models…Pharmacia Diagnostics AB · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K982533 | Unicap Gliadin Iga Assay | Pharmacia & Upjohn Co. | 1998 | — |
| 0 (this device) | K052793 | Immunocap/Unicap Gliadin Iga, Immunocap/Unicap Specific Iga, Models… | Pharmacia Diagnostics AB | 2006 | — |
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 MST? 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 |
|---|---|---|---|
| * | K982533 | Unicap Gliadin Iga AssaySummary page 1…Class CFR 82 MST II 866.5750 Substantial Equivalence to: UniCAP® Gliadin IgA K982533 Note: Pharmacia Diagnostics AB is in the process of changing brand names from UniCAP to ImmunoCAP. You may notice that there are… | 1998 |
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 no recall.
How does its category compare?
All MST devicesMST Antibodies, Gliadin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MST
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MST
Too few MST 510(k)s in any year since 2007 to give a median.
Recalls per year · MST
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MST
No MAUDE report names MST since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 1 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 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?
ImmunoCAP/UniCAP Gliadin IgA/IgG ImmunoCAP® is a device for the in vitro semi-quantitative measurement of IgA or IgG antibodies specific for gliadin in human serum. ImmunoCAP/UniCAP Gliadin IgA/IgG ImmunoCAP is intended to be used with the instrument immunoCAP/UniCAP together with reagents as stated in the Directions for Use provided with ImmunoCAP/UniCAP Specific IgA and ImmunoCAP/UniCAP Specific IgG. It is intended for in vitro diagnostic use as an aid…
Read the full statement (162 words)
ImmunoCAP/UniCAP Gliadin IgA/IgG ImmunoCAP® is a device for the in vitro semi-quantitative measurement of IgA or IgG antibodies specific for gliadin in human serum. ImmunoCAP/UniCAP Gliadin IgA/IgG ImmunoCAP is intended to be used with the instrument immunoCAP/UniCAP together with reagents as stated in the Directions for Use provided with ImmunoCAP/UniCAP Specific IgA and ImmunoCAP/UniCAP Specific IgG. It is intended for in vitro diagnostic use as an aid in the diagnosis of patients with celiac disease.
ImmunoCAP/UniCAP Specific IgA is an in vitro test system for the quantitative measurement of antigen specific IgA antibodies. The corresponding antigen for the specific antibody to be measured by ImmunoCAP/UniCAP Specific IgA is bound to the Antigen ImmunoCAP solid phase component of the ImmunoCAP/UniCAP Specific IgA system. ImmunoCAP/UniCAP Specific IgA assay is to be used with the instrument ImmunoCAP/UniCAP. It is intended for in vitro diagnostic use in conjunction with other clinical findings, and is to be used in clinical laboratories, as well as physician office laboratories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052793 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052793: Immunocap/Unicap Gliadin Iga, Immunocap/Unicap Specific Iga, Models 14-4425-40, 10-9306-02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052793
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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