Home / 510(k) Clearances / K111956

510(k) K111956

KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT by Kronus Market Development Associates, Inc. — Product Code PAF

K111956 is an FDA 510(k) premarket notification submitted by Kronus Market Development Associates, Inc. for the device "KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT". The FDA issued a decision of Substantially Equivalent on May 30, 2012. The device falls under product code PAF (Voltage Gated Calcium Channel (Vgcc) Antibody Assay), a Class II device regulated under 21 CFR 866.5660. Kronus Market Development Associates, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2012
Date Received
July 11, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Voltage Gated Calcium Channel (Vgcc) Antibody Assay
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

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.

Other clearances by Kronus Market Development Associates, Inc.

  • DEN140001 — ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT (August 20, 2014)
  • K121046 — STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT (December 20, 2012)
  • K080523 — KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT (June 17, 2008)
  • K080159 — KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT (May 22, 2008)
  • K073590 — KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT (April 10, 2008)
  • K072135 — KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT (November 7, 2007)
  • K070183 — KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT (July 13, 2007)
  • K051061 — KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT (November 4, 2005)
  • K042248 — KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT (December 17, 2004)
  • K032134 — TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT (September 10, 2003)

FDA data resources