510(k) · Cleared
ClearedImmulisa Enhanced (TM) Cardiolipin Iga, Igg, Igm and Iga/Igg/Igm Antibody (Aca) Elisas
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immco Diagnostics, Inc. · MID System, Test, Anticardiolipin Immunological
Cleared on Oct 25, 2012 after a 380-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 25, 2012
- Review
- 380 days
- Class
- Class II
- Product code
- MID
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 MID devicesMID System, Test, Anticardiolipin Immunological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgA antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings. Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgG antibodies in human serum to aid in the…
Read the full statement (173 words)
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgA antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgG antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.
Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgM antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.
Enzyme linked immunoassay (ELISA) for the qualitative detection of Cardiolipin IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of anti-phospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K113020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113020: Immulisa Enhanced (TM) Cardiolipin Iga, Igg, Igm and Iga/Igg/Igm Antibody (Aca) Elisas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113020
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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