Search Results

An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of anti-human Tissue Transglutaminase IgG antibodies in human serum to aid in the diagnosis of celiac disease (CD) in patients with IgA deficiency.

An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of IgA and IgG antibodies to human tissue Transglutaminase to aid in diagnosis of Celiac Disease (CD).

An enzyme linked immunoassay (ELISA)

This letter from the FDA (MAR - 5 2004) states that the Immulisa Anti-human tissue Transglutaminase (human tTG) IgG ELISA (K040096) and Immulisa Anti-human tissue Transglutaminase (human tTG) Total IgA/IgG Antibody ELISA (K040095) have been reviewed and determined to be substantially equivalent to legally marketed predicate devices. This is a 510(k) premarket notification and therefore, does not contain acceptance criteria or study results within these documents.

The provided text consists of FDA clearance letters (510(k) notifications) for two Immulisa devices. These letters primarily confirm that the devices are "substantially equivalent" to predicate devices already on the market and do not contain detailed information regarding acceptance criteria, study designs, or performance data.

Therefore, I cannot provide the requested information. To fulfill this request, a different document, such as the actual 510(k) submission or a scientific publication discussing the validation studies for these devices, would be necessary.

Ask a specific question about this device