PGV

Anti-Phospholipase A2 Receptor

Product code

PGV

Device name

Anti-Phospholipase A2 Receptor

Device class

Class 2

21 CFR

21 CFR 866.5780

Medical specialty

Microbiology

Marketing pathway

510(K)

Flag

Life-sustaining / life-supporting

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).