DeviceClearance

Product code PGV— Microbiology

EUROIMMUN ANTI-PLA2R ELISA (IGG)

Classification name
Anti-Phospholipase A2 Receptor
Device class
Class 2
Regulation
21 CFR 866.5780
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PGV under 21 CFR 866.5780, via openFDA

Market context for product code PGV

FDA has cleared 2 devices under product code PGV, all in 2014, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PGV

Recent clearances under product code PGV

Data sourced from openFDA. This site is unofficial and independent of the FDA.