510(k) · Cleared
ClearedHemosil Acustar Cardiolipin Igg, Igm and Igg and Igm Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · MID System, Test, Anticardiolipin Immunological
Cleared on Mar 11, 2010 as substantially equivalent to K022992 (Corgenix, Inc., 2002) after a 233-day review. Its family tree reaches back 1 generation to 2002. 3 later devices descend from it.
- Decided
- Mar 11, 2010
- Review
- 233 days
- Class
- Class II
- Product code
- MID
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K022992 (2002). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK022992 Reaads Anti-Cardiolipin Igg/Igm Semi-Quantitative Test Kit, Model…Corgenix, Inc. · 2002
- This deviceK092181 Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm ControlsInstrumentation 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 | K022992 | Reaads Anti-Cardiolipin Igg/Igm Semi-Quantitative Test Kit, Model 023-001 | Corgenix, Inc. | 2002 | — |
| 0 (this device) | K092181 | Hemosil Acustar Cardiolipin Igg, Igm and Igg and 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 MID? 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 MID device
- #1 K223093 Aptiva APS IgG Reagent; Aptiva APS IgM Reagentscore 8.8 · 2 generations · 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 |
|---|---|---|---|
| * | K022992 | Reaads Anti-Cardiolipin Igg/Igm Semi-Quantitative Test Kit, Model 023-001Summary page 1…: MID (System Test, Anti-Cardiolipin Immunological); JYX (Controls) Panel: Immunology (82) Identification of Predicate Devices: K022992 REAADS Anti-Cardiolipin IgG/IgM Semii-Quantitative Test Kit Device Indications for Uses: HemoslL AcuSta… | 2002 |
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?
How does its category compare?
All MID devicesMID System, Test, Anticardiolipin Immunological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
HemosiL AcuStar Anti-Cardiolipin IgG: Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-cardiolipin (aCL) IgG antibodies in human citrate 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-Cardiolipin IgG Controls: For the…
Read the full statement (146 words)
HemosiL AcuStar Anti-Cardiolipin IgG: Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-cardiolipin (aCL) IgG antibodies in human citrate 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-Cardiolipin IgG Controls: For the quality control of the Anti-Cardiolipin IgG assay performed on the ACL AcuStar.
HemosIL AcuStar Anti-Cardiolipin IgM: Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-cardiolipin (aCL) 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-Cardiolipin IgM Controls: For the quality control of the Anti-Cardiolipin IgM assay performed on the ACL AcuStar.
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/K092181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092181: Hemosil Acustar Cardiolipin Igg, Igm and Igg and Igm Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092181
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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