510(k) · Cleared
ClearedQAB2A Igm Elisa Kit HRP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cheshire Diagnostics, Ltd. · MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Cleared on Jul 12, 2002 after a 57-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jul 12, 2002
- Review
- 57 days
- Class
- Class II
- Product code
- MSV
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 MSV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MSV device
- #1 K243979 Aptiva APS IgA Reagentscore 10.8 · 1 generation · no Class I recall
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 MSV devicesMSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSV
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · MSV
Too few MSV 510(k)s in any year since 2007 to give a median.
Recalls per year · MSV
No recall names MSV since 2007.
Adverse event reports per year · MSV
No MAUDE report names MSV since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 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 | 1 | — | 0 | — |
What is it indicated for?
The Cheshire Diagnostics Limited QAPzA IgM Elisa Kit HRP is an Enzyme Linked Immunoassay for the in vitro semi-quantitative detection of IgM antibodies to P2-Giycoprotein-l in human serum. The presence of Pz-GPI antibodies can be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis in patients with Systemic Lupus Erythematosus or other lupus like disorders.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K021610 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021610: QAB2A Igm Elisa Kit HRP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021610
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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