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QUANTA Flash ENA7 is a chemiluminescent immunoassay for the qualitative screening of IgG autoantibodies to Sm, RNP, Ro60 (SS-A), Ro52/TRIM21, SS-B (La), Scl-70 (topoisomerase I) and Jo-1 in human serum. The presence of these autoantibodies is used as an aid in the diagnosis of systemic lupus erythematosus (SLE), systemic sclerosis (SSc), polymyositis (PM), dermatomyositis (DM), sjogren's syndrome (SjS) and mixed connective tissue disease (MCTD) in conjunction with clinical findings and other laboratory tests.

QUANTA Flash ENA7 Calibrators are intended for use with the QUANTA Flash ENA7 Reagents for the determination of IgG autoantibodies to Sm, RNP, Ro60 (SS-A), Ro52/TRIM21, SS-B (La), Scl-70 (topoisomerase I) and Jo-1 in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate the unit values.

QUANTA Flash ENA7 Controls are intended for use with the QUANTA Flash ENA7 Reagents for quality control in the determination of IgG autoantibodies to Sm, RNP, Ro60 (SS-A), Ro52/TRIM21, SS-B (La), Scl-70 (topoisomerase I) and Jo-1 in human serum.

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It seems that the provided text is a set of FDA 510(k) clearance letters and "Indications for Use" forms for the "QUANTA Flash ENA7 Reagent Kit", "QUANTA Flash ENA7 Calibrator Kit", and "QUANTA Flash ENA7 Control Kit".

This type of document does not typically contain detailed information about the acceptance criteria or a study proving the device meets those criteria, as requested in your prompt. These documents primarily focus on:

• The FDA's decision regarding substantial equivalence to a legally marketed predicate device.
• The regulation number and class of the device.
• The specific indications for use for which the device has been cleared.
• Contact information for FDA regulations and reporting.

Therefore,Based on the provided text, I cannot extract the information required to populate the table of acceptance criteria and the details of a study proving the device meets those criteria. The provided documents are FDA clearance letters and indications for use, which state that the device is substantially equivalent to a predicate device and outline its intended use, but they do not contain the specific study details, acceptance criteria, or performance data of a validation study.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (such as an FDA Executive Summary or a scientific publication describing the validation study).

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