510(k) · Cleared
ClearedQuanta Lite B2GPI Igg
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Cleared on Jun 24, 1997 after a 132-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Jun 24, 1997
- Review
- 132 days
- Class
- Class II
- Product code
- MSV
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK970551 Quanta Lite B2GPI IggInova Diagnostics, Inc. · 1997
- 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 ownK152875 QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls…Inova Diagnostics, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK141274 Quanta Flash ¿2GP1-DOMAIN1; Controls, Hemosil Acustar Anti-¿2GPI…Inova Diagnostics, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK982391 Reaads Igg Anti-B2GPI Test KitCorgenix, Inc. · 1998
Most influential descendants
Showing 4 of 4 · See all- K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc. · 2024 · cites it directly0descendants
- K152875QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar…Inova Diagnostics, Inc. · 2015 · cites it directly0descendants
- K141274Quanta Flash ¿2GP1-DOMAIN1; Controls, Hemosil Acustar Anti-¿2GPI DOMAIN1; Controls.Inova Diagnostics, Inc. · 2015 · cites it directly0descendants
- K982391Reaads Igg Anti-B2GPI Test KitCorgenix, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970551 | Quanta Lite B2GPI Igg | Inova Diagnostics, Inc. | 1997 | — |
| +1 | K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | Inova Diagnostics, Inc. | 2024 | — |
| +1 | K152875 | QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL… | Inova Diagnostics, Inc. | 2015 | — |
| +1 | K141274 | Quanta Flash ¿2GP1-DOMAIN1; Controls, Hemosil Acustar Anti-¿2GPI DOMAIN1… | Inova Diagnostics, Inc. | 2015 | — |
| +1 | K982391 | Reaads Igg Anti-B2GPI Test Kit | Corgenix, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2015 | 2 | 0 |
| 2024 | 1 | 0 |
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? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | 2024 | 0 |
| K152875 | QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar… | 2015 | 0 |
| K141274 | Quanta Flash ¿2GP1-DOMAIN1; Controls, Hemosil Acustar Anti-¿2GPI DOMAIN1; Controls. | 2015 | 0 |
| K982391 | Reaads Igg Anti-B2GPI Test Kit | 1998 | 0 |
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?
- 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.
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?
A semiquantitative enzyme linked immunoassay for detecting IgG class autoantibody to β2 glycoprotein I (β2 GPI), for use as an aid in the diagnosis of certain autoimmune disease thrombotic disorders, such as those secondary to systemic lupus erythematosus or other lupus like thrombotic diseases.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970551 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970551: Quanta Lite B2GPI Igg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970551
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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