510(k) · Cleared
Recalled · 2009Reaads II Anti-Cardiolipin Igg Semi-Quantitative Test Kit, Model 11139
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Corgenix, Inc. · MID System, Test, Anticardiolipin Immunological
Cleared on Oct 14, 2003 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.
- Decided
- Oct 14, 2003
- Review
- 29 days
- Class
- Class II
- Product code
- MID
- Recalls
- 1
- 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 14, 2009 | Not classified | Z-1145-2010 | Nonconforming Material/Component | The firm received customer complaints of microbial contamination in Positive Controls in its Anti-Cardiolipin IgM Test Kit Lot CL-863. |
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.
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 FSAADS" I1 Anti-Cardiolipin IgM Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-cardiolipin IgM antibodies in human serum or plasma. For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-li ke disorders (anti-phospholipid syndrome). The REAADS@I1 Anti-Cardiolipin IgM Semi-Quantitative Test Kit is…
Read the full statement (792 words)
The FSAADS" I1 Anti-Cardiolipin IgM Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-cardiolipin IgM antibodies in human serum or plasma.
For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-li ke disorders (anti-phospholipid syndrome).
The REAADS@I1 Anti-Cardiolipin IgM Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
The REAADS' I1 Anti-Cardiolipin IgG Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-cardiolipin IgG antibodies in human serum or plasma.
For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).
The REAADS' I1 Anti-Cardiolipin IgG Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
The REAADSO I1 Anti-Cardiolipin IgA Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-cardiolipin IgA antibodies in human serum or plasma.
For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-li ke disorders (anti-phospholipid syndrome).
The REAADS@I1 Anti-Cardiolipin IgA Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
The REAADS@ I1 Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-phosphatidylserine IgG antibodies in human serum or citrated plasma (3.2% sodium citrate).
Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythematosus (SLE) and Iupus-like disorders (anti-phospholipid syndrome).
The R E A D S @I1 Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
The REAADS' I1 Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-phosphatidylserine IgM antibodies in human serum or citrated plasma (3.2% sodium citrate).
Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).
The FEAADS@I1 Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
The REAADS@ I1 Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-phosphatidylserine (aPS) IgA antibodies in human serum and citrated plasma (3.2% sodium citrate).
Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).
The REAADS@I1 Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
The REAADS@ I1 Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit is an- enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-Beta 2 Glycoprotein 1 (P2GPl) IgG antibodies in human serum or citrated plasma (3.2% sodium citrate).
For the detection and semi-quantitation of anti-P2GPl IgG antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).
The REAADS@I1 Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
The REAADS@I1 Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-Beta 2 Glycoprotein 1 (P2GPI) IgM antibodies in human serum or citrated plasma (3.2% sodium citrate).
For the detection and semi-quantitation of anti-02GPl IgM antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).
The REAADS@I1 Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
The REAADS' I1 Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit is an. enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-Beta 2 Glycoprotein 1 (P2GPI) IgA antibodies in human serum or citrated plasma (3.2% sodium citrate).
For the detection and semi-quantitation of anti-P2GP1 IgA antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).
The REAADS' I1 Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
The REAADS@I1 Anti-Prothrombin IgG Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-prothrombin (aPT) IgG antibodies in human serum or citrated plasma (3.2% sodium citrate).
For the detection and semi-quantitation of anti-prothrombin (aPT) IgG antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (e.g., antiphospholipid syndrome).
The REAADS@11 Anti- Prothrombin IgG Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
The REAADS' I1 Anti-Prothrombin IgM Semi-QuantitativeTest Kit is an enzyme-linked inimunosorbent assay (ELISA) for the semi-quantitative determination of anti-prothrombin (aPT) IgM antibodies in human serum or citrated plasma (3.2% sodium citrate).
For the detection and semi-quantitation of anti-prothrombin (aPT) IgM antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (e.g., antiphospholipid syndrome).
The REAADS' I1 Anti- Prothrombin IgM Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K032868 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032868: Reaads II Anti-Cardiolipin Igg Semi-Quantitative Test Kit, Model 11139.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032868
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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