# K991942: Autostat II Anti-GPC Elisa, HY.Tec Anti-GPC Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Cogent Diagnotics, Ltd.
- Decided: Aug 24, 1999 after 76 days
- Product code: MLE (Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control)
- Device class: 2
- Regulation: 21 CFR 866.5110
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to Gastric Parietal Cell (GPC) in human serum. 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 HyeTec Automated EIA instrument. 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.

Source page: https://510kreport.com/device/K991942
Methodology: https://510kreport.com/methodology