# K111956: Kronus Voltage Gated Calcium Channel (VGCC) Antibody Ria Assay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Kronus Market Development Associates, Inc.
- Decided: May 30, 2012 after 324 days
- Product code: PAF (Voltage Gated  Calcium Channel (Vgcc) Antibody Assay)
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The KRONUS Voltage Gated Calcium Channel (VGCC) Antibody RIA Assay Kit is for the semi-quantitative determination of antibodies to voltage gated calcium channels in human serum. The VGCC antibody may be present in patients diagnosed with Lambert-Eaton Myasthenic Syndrome (LEMS). The assay result is not to be used alone and is to be used in conjunction with other clinical, electrodiagnostic and laboratory findings.

Source page: https://510kreport.com/device/K111956
Methodology: https://510kreport.com/methodology