DeviceClearance

Product code PAF— Immunology

KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT

Classification name
Voltage Gated Calcium Channel (Vgcc) Antibody Assay
Device class
Class 2
Regulation
21 CFR 866.5660
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

FDA classification definition

“Intended for semi-quantitative determination of VGCC Antibody in human serum. The VGCC Ab may be present in patients diagnosed with Lambert-Eaton Syndrome (LEMS). The assay result is not to be used alone and to be used in conjunction with other clinical, electrodiagnostic and laboratory findings.”

— U.S. Food and Drug Administration, device classification record for product code PAF under 21 CFR 866.5660, via openFDA

Market context for product code PAF

FDA has cleared 1 device under product code PAF, all in 2012, filed by 1 applicant company. 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 PAF

Recent clearances under product code PAF

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