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Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to Gastric Parietal Cell (GPC) in human serum.

Uses:

The results of the anti-GPC assay can be used as an aid in the diagnosis of diseases associated with elevated levels of anti-GPC antibodies including Pernicious Anaemia.

Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.

For in vitro diagnostic use only.

Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to GPC in human serum. This device is designed for use with the Hycor Hy•Tec Automated EIA instrument.

This request pertains to the acceptance criteria and study details of the device mentioned in the provided text. However, the provided document is a 510(k) clearance letter and an "Indications for Use" statement for the Cogent Autostat™ II α-GPC ELISA and Hycor Hy•Tec α-GPC ELISA devices.

This type of document does not contain the detailed study results, acceptance criteria, or performance metrics that would typically be found in a clinical study report or a premarket submission summary. The 510(k) clearance letter confirms that the FDA has found the device substantially equivalent to a legally marketed predicate device, based on the information provided in the original submission.

Therefore, I cannot extract the specific information requested about acceptance criteria and study details from the provided text. The document primarily focuses on the regulatory clearance of the device.

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