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The QUANTA Flash h-tTG IgG is a chemiluminescent immunoassay (CIA) for the semi-quantitative detection of IgG anti-human tissue transglutaminase (h-ITG) antibodies in human serum. The presence of IgG anti-h-tTG antibodies, in conjunction with clinical findings and other laboratory tests, can aid in the diagnosis of the gluten sensitive enteropathy celiac disease, particularly in patients with selective IgA deficiency.

The QUANTA Flash™ h-tTG IgG Calibrators are intended for use with the QUANTA Flash™ h-tTG IgG chemiluminescent immunoassay (CIA) on the BIO-FLASH® instrument. Each calibrator establishes a point of reference for the working curve that is used to determine values in the measurement of IgG anti-h-tTG antibodies in serum.

The QUANTA Flash™ h-tTG IgG Controls are intended for quality control purposes of the QUANTA Flash™ h-tTG IgG chemiluminescent immunoassay (CIA) kit run on a BIO-FLASH® instrument.

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This document describes the FDA's decision to clear the QUANTA Flash™ h-tTG IgG device, along with its calibrators and controls, as substantially equivalent to legally marketed predicate devices. The document does not contain the acceptance criteria for a study proving the device meets those criteria, nor any of the detailed study information requested in your prompt (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).

The FDA letter confirms that the device can be marketed based on its substantial equivalence to existing devices, implying that the provided information (not included in this excerpt) was sufficient to demonstrate this. However, it does not disclose the specific performance metrics or detailed study design used to support this claim in the way you've outlined for a typical AI/medical device acceptance criteria and study report.

Therefore, I cannot provide the requested table and study details.

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