510(k) · Cleared
ClearedAptiva APS IgA Reagent
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 Feb 6, 2026 as substantially equivalent to K120817 (Inova Diagnostics, Inc., 2013) after a 410-day review. Its family tree reaches back 1 generation to 2013.
- Decided
- Feb 6, 2026
- Review
- 410 days
- Class
- Class II
- Product code
- MSV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K120817 (2013). No later device cites it as a predicate yet.
- Root · 1 generation backK120817 Quanta Flash Acl Lga, Quanta Flash B2GP1 IgaInova Diagnostics, Inc. · 2013
- This deviceK243979 Aptiva APS IgA ReagentInova Diagnostics, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K120817 | Quanta Flash Acl Lga, Quanta Flash B2GP1 Iga | Inova Diagnostics, Inc. | 2013 | — |
| 0 (this device) | K243979 | Aptiva APS IgA Reagent | Inova Diagnostics, Inc. | 2026 | — |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K120817 | Quanta Flash Acl Lga, Quanta Flash B2GP1 IgaSummary page 7…510(k) Summary Aptiva APS IgA Reagent Page 3 of 18 Predicate device QUANTA Flash® aCL IgA, 510(k) number: K120817 QUANTA Flash® β2GP1 IgA, 510(k) number: K120817 Device description The Aptiva APS IgA reagent utilize particle based multi-anal… | 2013 |
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?
- Its one ancestor has no 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. 2026, 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?
The Aptiva APS IgA Reagent is an immunoassay utilizing particle-based multi-analyte technology for the semi-quantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aβ2GPI) IgA autoantibodies in human serum as an aid in the diagnosis of primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory and clinical findings.
The Aptiva APS IgA Reagent is intended for use with the Aptiva System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243979 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243979: Aptiva APS IgA Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243979
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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