# K032868: Reaads II Anti-Cardiolipin Igg Semi-Quantitative Test Kit, Model 11139

- Pathway: 510(k) (Special)
- Applicant: Corgenix, Inc.
- Decided: Oct 14, 2003 after 29 days
- Product code: MID (System, Test, Anticardiolipin Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Jul 14, 2009 · Not classified · Z-1145-2010: The firm received customer complaints of microbial contamination in Positive Controls in its Anti-Cardiolipin IgM Test Kit Lot CL-863.

## Indications for use
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.

Source page: https://510kreport.com/device/K032868
Methodology: https://510kreport.com/methodology