510(k) · Cleared
ClearedUnicap Gliadin Iga Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmacia & Upjohn Co. · MST Antibodies, Gliadin
Cleared on Oct 22, 1998 after a 94-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 later device descends from it.
- Decided
- Oct 22, 1998
- Review
- 94 days
- Class
- Class II
- Product code
- MST
- Recalls
- None
- Predicates
- 1
1 later device descends from it, 1 citing it directly.
- This deviceK982533 Unicap Gliadin Iga AssayPharmacia & Upjohn Co. · 1998
- Descendant · cites it directly · 0 of its ownK052793 Immunocap/Unicap Gliadin Iga, Immunocap/Unicap Specific Iga, Models…Pharmacia Diagnostics AB · 2006
Most influential descendants
Showing 1 of 1 · See all- K052793Immunocap/Unicap Gliadin Iga, Immunocap/Unicap Specific Iga, Models 14-4425-40, 10-9306-02Pharmacia Diagnostics AB · 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) | K982533 | Unicap Gliadin Iga Assay | Pharmacia & Upjohn Co. | 1998 | — |
| +1 | K052793 | Immunocap/Unicap Gliadin Iga, Immunocap/Unicap Specific Iga, Models… | Pharmacia Diagnostics AB | 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 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K982701 | FDA’s K982701 is Unicap Gliadin Igg Assay Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1998 |
| * | — | ImmuLisa™ IgA Anti-Gliadin Antibody Named without a submission number |
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 |
|---|---|---|---|
| K052793 | Immunocap/Unicap Gliadin Iga, Immunocap/Unicap Specific Iga, Models 14-4425-40, 10-9306-02 | 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, K052793 (Pharmacia Diagnostics AB, 2006) has gone furthest, with 0 descendants of its own.
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?
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. UniCAP Gliadin IgA/IgG ImmunoCAP is intended to be used with the instrument UniCAP together with reagents as stated in the Directions for Use provided with UniCAP Specific IgA. It is intended for in vitro diagnostic use as an aid in the diagnosis of patients with celiac disease. UniCAP Specific IgA is…
Read the full statement (316 words)
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. UniCAP Gliadin IgA/IgG ImmunoCAP is intended to be used with the instrument UniCAP together with reagents as stated in the Directions for Use provided with UniCAP Specific IgA. It is intended for in vitro diagnostic use as an aid in the diagnosis of patients with celiac disease.
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 UniCAP Specific IgA is bound to the Antigen ImmunoCAP solid phase component of the UniCAP Specific IgA system. UniCAP Specific IgA assay is to be used with the instrument 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.
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. UniCAP Gliadin IgA/IgG ImmunoCAP is intended to be used with the instrument UniCAP together with reagents as stated in the Directions for Use provided with UniCAP Specific IgG. It is intended for in vitro diagnostic use as an aid in the diagnosis of patients with celiac disease.
UniCAP Specific IgG is an in vitro test system for the quantitative measurement of antigen specific IgG antibodies. The corresponding antigen for the specific antibody to be measured by UniCAP Specific IgG is bound to the Antigen ImmunoCAP solid phase component of the UniCAP Specific IgG system. UniCAP Specific IgG assay is to be used with the instrument 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982533 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982533: Unicap Gliadin Iga Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982533
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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