510(k) · Cleared
ClearedVirgo B2 Glycoprotein I Iga Antibody Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemagen Diagnostics, Inc. · MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Cleared on Aug 30, 1999 as substantially equivalent to K932373 (Hemagen Diagnostics, Inc., 1993) and 1 other predicate after a 60-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Aug 30, 1999
- Review
- 60 days
- Class
- Class II
- Product code
- MSV
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932373 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK932373 Hemagen Cardiolipin Antibody Kit (Eia METHOD0Hemagen Diagnostics, Inc. · 1993
- This deviceK992241 Virgo B2 Glycoprotein I Iga Antibody KitHemagen Diagnostics, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932373 | Hemagen Cardiolipin Antibody Kit (Eia METHOD0 | Hemagen Diagnostics, Inc. | 1993 | — |
| 0 (this device) | K992241 | Virgo B2 Glycoprotein I Iga Antibody Kit | Hemagen Diagnostics, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K932373 | Hemagen Cardiolipin Antibody Kit (Eia METHOD0Summary page 1…bodies Test System Classification Name: Multiple Autoantibodies iImmunological Test System Predicates Trade Name: Hemagen ® Cardiolipin Antibody Kit 510 (k) Docket No. K 932373, SE Date; 16 July 1993 Trade Name: Hemagen ® Cardiolipin IgA Calibrator 510 (k) Docket No. K 941840, SE Date; 30 june 1994 The… | 1993 |
| * | K941840 | Hemagen Acl Iga CalibratorSummary page 1…Trade Name: Hemagen ® Cardiolipin Antibody Kit 510 (k) Docket No. K 932373, SE Date; 16 July 1993 Trade Name: Hemagen ® Cardiolipin IgA Calibrator 510 (k) Docket No. K 941840, SE Date; 30 june 1994 The performance of the VIRGO @ 8, Glycoprotein | IgA Antibody Kit was evaluated with a panel of character… | 1994 |
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 2 ancestors has a recall.
- 3 other devices also cite its predicate K932373.
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?
This enzyme-linked immunosorbent assay (ELISA) is indicated for the detection and measurement of circulating IgA antibodies to B, Glycoprotein in human serum. The presence of these antibodies, in combination with clinical observations and other serological tests, can aid in the diagnosis of Primary and Secondary Antiphospholipid Syndrome.
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/K992241 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992241: Virgo B2 Glycoprotein I Iga Antibody Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992241
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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