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The REAADS® II 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-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Cardiolipin IgM Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The REAADS® II 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® II Anti-Cardiolipin IgG Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The REAADS® II 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-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Cardiolipin IgA Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The REAADS II 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 lupus-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The REAADS II Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-phosphatidy/serine 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 REAADS® II Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The REAADS® II 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® II Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The REAADS® II 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 (B2GP1) IgG antibodies in human serum or citrated plasma (3.2% sodium citrate). For the detection and semi-quantitation of anti-ß2GPI IgG antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The REAADS® II 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 l (ß2GPI) IgM antibodies in human serum or citrated plasma (3.2% sodium citrate). For the detection and semi-quantitation of antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The REAADS® II Anti-Beta 2 Glycoprotein 1 IgA Semi-Quantitative Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative determination of anti-Beta 2 Glycoprotein 1 (B2GPI) IgA antibodies in human serum or citrated plasma (3.2% sodium citrate). For the detection and semi-quantitation of antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). The REAADS® II Anti-Beta 2 Glycoprotein 1 IgA Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The REAADS® II 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 with systemic lupus erythematosus (SLE) and lupus-like disorders (e.g., antiphospholipid syndrome). The REAADS® II Anti- Prothrombin IgG Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The REAADS® II Anti-Prothrombin IgM Semi-Quantitative Test Kit is an enzyme-linked immunosorbent 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® II Anti- Prothrombin IgM Semi-Quantitative Test Kit is intended to be used by clinical (hospital and reference) laboratories.

The device is an enzyme-linked immunosorbent assay (ELISA) kit for the semi-quantitative determination of specific antibodies in human serum or plasma.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, or how ground truth was established for "REAADS II anti-Cardiolipin IgG Semi-quantitative Test Kit" or any of the other listed REAADS II test kits.

The document is a 510(k) premarket notification letter from the FDA to Corgenix, Inc., confirming substantial equivalence for a series of REAADS II anti-phospholipid antibody test kits. It primarily lists the device names, regulation numbers, regulatory class, product codes, and indications for use for each kit. While it states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...", it does not provide the details of the studies or data that led to this determination.

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