510(k) · Cleared
ClearedDiastat Anti-B2 Glycoprotein 1 Igm, Model FBGP 100M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axis-Shield Diagnostics, Ltd. · MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Cleared on Jun 19, 2003 after a 66-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 19, 2003
- Review
- 66 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 Diastat "Anti Beta 2 GLYCOPROTEIN I IgM test is a semiquantitative/qualitative enzyme-linked immunosorbent Assay (ELISA) for the detection the IgM class of autoantibodies to b2 GP1 in human serum, or sodium citrate, EDTA(K2). and lithium heparin anti-coagulated plasma.
It is intended to aid in the assessment of thrombotic risk in patients with autoimmune disease associated with thrombotic disorders such as those with Primary Anti Phospholipid Syndrome (PAPS) or secondary to Systemic Lupus Erythematosus and is not definitive in isolation. Autoantibody levels represent one parameter in a multicriterion diagnostic process.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K031177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031177: Diastat Anti-B2 Glycoprotein 1 Igm, Model FBGP 100M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031177
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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