510(k) · Cleared
ClearedHemosil Acustar Anti-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Cleared on May 21, 2010 as substantially equivalent to K031208 (Corgenix, Inc., 2003) after a 359-day review. Its family tree reaches back 1 generation to 2003. 3 later devices descend from it.
- Decided
- May 21, 2010
- Review
- 359 days
- Class
- Class II
- Product code
- MSV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031208 (2003). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK031208 Reaads Igm Anti-B2GPI Test Kit, Model 038-001Corgenix, Inc. · 2003
- This deviceK091556 Hemosil Acustar Anti-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm…Instrumentation Laboratory CO · 2010
- Descendant · cites it directly · 0 of its ownK223093 Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK221359 ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2…Instrumentation Laboratory CO · 2023
- Descendant · cites it directly · 0 of its ownK130528 Bioplex 2200 Apls IgmBio-Rad Laboratories · 2013 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc. · 2024 · cites it directly0descendants
- K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory CO · 2023 · cites it directly0descendants
- K130528Bioplex 2200 Apls IgmBio-Rad Laboratories · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031208 | Reaads Igm Anti-B2GPI Test Kit, Model 038-001 | Corgenix, Inc. | 2003 | — |
| 0 (this device) | K091556 | Hemosil Acustar Anti-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm Controls | Instrumentation Laboratory CO | 2010 | — |
| +1 | K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | Inova Diagnostics, Inc. | 2024 | — |
| +1 | K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2… | Instrumentation Laboratory CO | 2023 | — |
| +1 | K130528 | Bioplex 2200 Apls Igm | Bio-Rad Laboratories | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K031208 | Reaads Igm Anti-B2GPI Test Kit, Model 038-001Summary page 1…rols) Product Code: MSV (Antibodies, 132 Glycoprotein I); JJX (Controls) Panel: Immunology Identification of Predicate Devices: K03 1208 REAADS IgG anti-fl 2 GPI Test Kit K03 1208 REAADS IgM anti-fl 2 OPI Test Kit Device… | 2003 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- Of its descendants, K223093 (Inova Diagnostics, Inc., 2024) has gone furthest, with 0 descendants of its own.
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. 2010, this device’s year, is highlighted.
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?
HemosIL™ AcuStar Anti-β2 Glycoprotein-I IgG: Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-β2 Glycoprotein-I (anti-β2 GPI) IgG antibodies in human citrated plasma and serum on the ACL AcuStar™, as an aid in the diagnosis of thrombotic disorders related to primary and secondary Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings. HemosIL™ AcuStar Anti-β2…
Read the full statement (156 words)
HemosIL™ AcuStar Anti-β2 Glycoprotein-I IgG: Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-β2 Glycoprotein-I (anti-β2 GPI) IgG antibodies in human citrated plasma and serum on the ACL AcuStar™, as an aid in the diagnosis of thrombotic disorders related to primary and secondary Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings.
HemosIL™ AcuStar Anti-β2 Glycoprotein-I IgG Controls: For the quality control of the Anti-β2 Glycoprotein-I IgG assay performed on the ACL AcuStar.
HemosIL™ AcuStar Anti-β2 Glycoprotein-I IgM: Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-β2 Glycoprotein-I (anti-β2 GPI) IgM antibodies in human citrated plasma and serum on the ACL AcuStar™ as an aid in the diagnosis of thrombotic disorders related to primary and secondary Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings.
HemosIL™ AcuStar Anti-β2 Glycoprotein-I IgM Controls: For the quality control of the Anti-β2 Glycoprotein-I IgM assay performed on the ACL AcuStar.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091556 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091556: Hemosil Acustar Anti-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091556
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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