Anti-Phospholipase A2 Receptor
The Anti-Phospholipase A2 Receptor (Anti-PLA2R) test system is an immunoassay intended for the qualitative determination of IgG class autoantibodies against phospholipase A2 receptor in human serum, used as an aid in the diagnosis of primary membranous glomerulonephritis (pMGN) in conjunction with other laboratory and clinical findings. It is an FDA Class 2 device regulated under 21 CFR 866.5780, requiring 510(k) clearance, within the Microbiology (MI) specialty. The product code is PGV, and it carries life-sustaining and third-party review flags. Results must be interpreted alongside other clinical information.
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Basic Information
- Product Code
- PGV
- Device Class
- FDA class 2
- Regulation Number
- 866.5780
- Medical Specialty
- Microbiology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
Definition
The test system is intended for the qualitative determination of IgG class autoantibodies against phospholipase A2 receptor (PLA2R) in human serum. It is used as an aid in the diagnosis of primary membranous glomerulonephritis (pMGN), in conjunction with other laboratory and clinical findings.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.