510(k) · Cleared
ClearedAptiva APS IgG Reagent; Aptiva APS IgM Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · MID System, Test, Anticardiolipin Immunological
Cleared on Dec 17, 2024 as substantially equivalent to K092181 (Instrumentation Laboratory CO, 2010) and 2 other predicates after an 809-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Dec 17, 2024
- Review
- 809 days
- Class
- Class II
- Product code
- MID
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K022992 (2002). 5 ancestors in all, the oldest K970551 (1997). No later device cites it as a predicate yet.
- Root · 2 generations backK022992 Reaads Anti-Cardiolipin Igg/Igm Semi-Quantitative Test Kit, Model…Corgenix, Inc. · 2002
- 1 generation backK092181 Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm ControlsInstrumentation Laboratory CO · 2010
- This deviceK223093 Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K022992 | Reaads Anti-Cardiolipin Igg/Igm Semi-Quantitative Test Kit, Model 023-001 | Corgenix, Inc. | 2002 | — |
| −1 | K092181 | Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm Controls | Instrumentation Laboratory CO | 2010 | — |
| 0 (this device) | K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | Inova Diagnostics, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2010 | 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 MID? 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? (3)
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 |
|---|---|---|---|
| * | K092181 | Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm ControlsSummary page 7…510(k) Summary Aptiva APS IgG and IgM Reagent Page 3 of 28 Predicate device HemosIL™ AcuStar Anti-Cardiolipin IgG, 510(k) number: K092181 QUANTA Lite™ Beta 2GP1 IgG ELISA, 510(k) number: K970551 HemosIL™ AcuStar Anti-Cardiolipin IgM, 510(k) number: K092181 HemosIL™ A… | 2010 |
| * | K970551 | Quanta Lite B2GPI IggSummary page 7…Page 3 of 28 Predicate device HemosIL™ AcuStar Anti-Cardiolipin IgG, 510(k) number: K092181 QUANTA Lite™ Beta 2GP1 IgG ELISA, 510(k) number: K970551 HemosIL™ AcuStar Anti-Cardiolipin IgM, 510(k) number: K092181 HemosIL™ AcuStar Anti-β2 Glycoprotein-I IgM, 510(k) number: K091556… | 1997 |
| * | K091556 | Hemosil Acustar Anti-B2 Glycoprotein-I; Igg, Igm, Igg Controls, Igm ControlsSummary page 7…te™ Beta 2GP1 IgG ELISA, 510(k) number: K970551 HemosIL™ AcuStar Anti-Cardiolipin IgM, 510(k) number: K092181 HemosIL™ AcuStar Anti-β2 Glycoprotein-I IgM, 510(k) number: K091556 Device description The Aptiva APS IgG and Aptiva APS IgM reagent utilize particle based multi-analyte technology (PMAT) in a ca… | 2010 |
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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 14.8 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K092181.
How does its category compare?
All MID devicesMID System, Test, Anticardiolipin Immunological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MID
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MID
234in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MID
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MID
1in 2023
MAUDE reports naming product code MID, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 3 | 234 | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Aptiva APS IgG 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) IgG autoantibodies in human serum as an aid in the diagnosis of primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory findings. The Aptiva APS IgG Reagent is intended for use with the Aptiva System. The Aptiva…
Read the full statement (128 words)
The Aptiva APS IgG 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) IgG autoantibodies in human serum as an aid in the diagnosis of primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory findings.
The Aptiva APS IgG Reagent is intended for use with the Aptiva System.
The Aptiva APS IgM 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) IgM autoantibodies in human serum as an aid in the diagnosis of primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory findings.
The Aptiva APS IgM Reagent is intended for use with the Aptiva System.
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/K223093 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223093: Aptiva APS IgG Reagent; Aptiva APS IgM Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223093
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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