Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
The Enzyme Immunoassay for Antiparietal Cell Antibody, Antigen, and Control is an in vitro diagnostic system used to detect antibodies directed against gastric parietal cells in patient serum, which are associated with autoimmune gastritis and pernicious anemia, supporting serological diagnosis of these autoimmune conditions. Classified as a Class 2 device under 21 CFR 866.5110 within the Immunology specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- MLE
- Device Class
- FDA class 2
- Regulation Number
- 866.5110
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K010558 | QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA | Apr 03, 2001 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K991942 | AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA | Aug 24, 1999 | Substantially Equivalent | Cogent Diagnotics , Ltd. |
| K951206 | VARELISA PARIETAL CELL ANTIBODIES | Apr 17, 1995 | Substantially Equivalent | Elias U.S.A., Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.