MLE · Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
Immunology · 21 CFR 866.5110 · Class 2
Overview
| Product Code | MLE |
|---|---|
| Device Name | Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control |
| Regulation | 21 CFR 866.5110 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
An antiparietal antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the specific antibody for gastric parietal cells in serum and other body fluids. Gastric parietal cells are those cells located in the stomach that produce a protein that enables vitamin B12 to be absorbed by the body. The measurements aid in the diagnosis of vitamin B12 deficiency (or pernicious anemia), atrophic gastritis (inflammation of the stomach), and autoimmune connective tissue diseases (diseases resulting when the body produces antibodies against its own tissues).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K010558 | QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA | Inova Diagnostics, Inc. | Apr 3, 2001 | SESE |
| K991942 | AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA | Cogent Diagnotics , Ltd. | Aug 24, 1999 | SESE |
| K951206 | VARELISA PARIETAL CELL ANTIBODIES | Elias U.S.A., Inc. | Apr 17, 1995 | SESE |
Top Applicants
- Cogent Diagnotics , Ltd. — 1 clearance
- Elias U.S.A., Inc. — 1 clearance
- Inova Diagnostics, Inc. — 1 clearance
