Cleared Traditional

K111956 - KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K111956 · Kronus Market Development Associates, Inc. · Immunology device
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May 2012
Decision
324d
Days
Class 2
Risk

K111956 is an FDA 510(k) clearance for the KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT. Classified as Voltage Gated Calcium Channel (vgcc) Antibody Assay (product code PAF), Class II - Special Controls.

Submitted by Kronus Market Development Associates, Inc. (Star, US). The FDA issued a Cleared decision on May 30, 2012 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K111956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2011
Decision Date May 30, 2012
Days to Decision 324 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
220d slower than avg
Panel avg: 104d · This submission: 324d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PAF Voltage Gated Calcium Channel (vgcc) Antibody Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.