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The KRONUS Voltage Gated Calcium Channel (VGCC) Antibody RIA Assay Kit is for the semiquantitative 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.

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This is an FDA 510(k) clearance letter for an in vitro diagnostic (IVD) device, specifically the "Kronus Voltage Gated Calcium Channel (VGCC) Antibody RIA Assay Kit." The document formally states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the detailed information required to answer your request about acceptance criteria and the study that proves the device meets those criteria.

FDA 510(k) clearance letters generally do not include the detailed study design, acceptance criteria tables, sample sizes, ground truth establishment, or expert qualifications that you've asked for. These details are typically found in the 510(k) submission itself, which is often a much longer and more technical document.

Therefore, I cannot provide the specific table and study information you've requested based solely on the provided text.

To answer your questions, one would need access to the actual 510(k) submission for K111956, which is generally not publicly available in its entirety without a Freedom of Information Act (FOIA) request to the FDA.

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