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EliA Cardiolipin IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to cardiolipin in human serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgA uses the EliA IgA method on the instruments Phadia 100.

EliA Cardiolipin IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to cardiolipin in human serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgA uses the EliA IgA method on the instruments Phadia 250.

The new device belongs to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments Phadia 100 and Phadia 250.

The conjugate for the EliA IgA method is mouse anti-human IgA beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate.

The total IgA calibration is based on a set of six WHO-standardized IgA Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method-specific and general reagents that are packaged as separate units.

The provided text describes the regulatory submission for the EliA™ Cardiolipin IgA Immunoassay and associated control devices. However, it does not contain any information about acceptance criteria or specific study results that prove the device meets such criteria.

The document primarily focuses on:

• 510(k) Summary details: Manufacturer, contact, device names, common name, classification, and date.
• Intended Use Statements: Explicitly stating what the EliA Cardiolipin IgA device is designed to measure (IgA antibodies to cardiolipin) and its purpose (aiding in diagnosis of APS and thrombotic disorders related to SLE) on Phadia 100 and Phadia 250 instruments.
• Special Conditions for Use: Prescription use only.
• Special Instrument Requirements: Phadia 100/250 automated immunoassay analyzers.
• General Description and Test Principle: Explains the fluorescence-immunoassay system, antigen coating, and methodology.
• Device Comparison: States that the new device and predicate (Quanta Lite IgA ACA (HRP), K953366) are both non-competitive solid phase ELISAs used for similar diagnostic aids.
• Laboratory Equivalence: Mentions that comparability is supported by a comparison study, clinically defined sera, and samples from healthy subjects, concluding with a statement of substantial equivalence.
• FDA Correspondence: Official letter acknowledging receipt and approval of the 510(k) submission, confirming substantial equivalence and providing regulatory information.
• Indications for Use Forms: Repeated forms for the main device and its associated positive and negative controls, reiterating their intended uses.

Therefore, I cannot provide the requested table of acceptance criteria and device performance, nor details about sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

The document states that a "comparison study between new and predicate device" and "results obtained for clinically defined sera" were used to support laboratory equivalence, but it does not present the data, the specific acceptance criteria, or the methodology of these studies.

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