(474 days)
The ZEUS ELISA Cardiolipin IgG/IgM/IgA Test System is intended for the in vitro, qualitative measurement of IgG, IgM and/or IgA antibodies directed to cardiolipin in human serum to aid in the diagnosis of primary antiphospholipid syndrome (PAPS) and secondary antiphospholipid syndrome (SAPS) in conjunction with other laboratory and clinical findings.
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I am sorry, but the provided text does not contain the detailed information required to answer your request about the acceptance criteria and the study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the "ZEUS ELISA Cardiolipin IgG/IgM/IgA Test System," describing its intended use and regulatory classification. It does not include specific study details such as:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for test sets.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Details on Multi-Reader Multi-Case (MRMC) studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This information would typically be found in a more detailed submission document, such as the 510(k) summary or a clinical study report, which is not provided here.
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).