510(k) · Cleared
ClearedImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immco Diagnostics, Inc. · MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Cleared on Jun 19, 2017 after a 259-day review. The FDA summary names its predicate without a number.
- Decided
- Jun 19, 2017
- Review
- 259 days
- Class
- Class II
- Product code
- MSV
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | INOVA QUANTA Lite™ β2 GPI IgA, IgG, IgM and Screen ELISAs Named without a submission number |
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. 2017, 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?
Enzyme-linked immunosorbent assay (ELISA) for the qualitative or semi-quantitative detection of p2-GPI IgA antibodies in human serum to aid in diagnosis of autoimmune thrombotic disorders associated with antiphospholipid syndrome (APS) and APS with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings. Enzyme-linked immunosorbent assay (ELISA) for the qualitative or semi-quantitative detection of p2-GPI 1gG…
Read the full statement (185 words)
Enzyme-linked immunosorbent assay (ELISA) for the qualitative or semi-quantitative detection of p2-GPI IgA antibodies in human serum to aid in diagnosis of autoimmune thrombotic disorders associated with antiphospholipid syndrome (APS) and APS with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.
Enzyme-linked immunosorbent assay (ELISA) for the qualitative or semi-quantitative detection of p2-GPI 1gG antibodies in human serum to aid in diagnosis of autoimmune thrombotic disorders associated with antiphospholipid syndrome (APS) and APS with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.
Enzyme-linked immunosorbent assay (ELISA) for the qualitative or semi-quantitative detection of f2-GPI IgM antibodies in human serum to aid in diagnosis of autoimmune thrombotic disorders associated with antiphospholipid syndrome (APS) and APS with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.
Enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of B2-GPI IgA, IgG and IgM antibodies in human serum to aid in diagnosis of autoimmune thrombotic disorders associated with antiphospholipid syndrome (APS) and APS with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.
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/K162788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162788: ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162788
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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