(324 days)
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.
Not Found
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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Image /page/0/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is an emblem that resembles a stylized eagle or bird figure. The emblem is composed of flowing lines and curves, giving it a dynamic and modern appearance.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Kronus Market Development Associates, Inc. c/o Ms. Heather Viele Director of Technical Affairs 170 S. Seneca Springs Way, Suite 105 Star, Idaho 83669
HAY 3 0 2012
Re: K111956
Trade/Device Name: Kronus Voltage Gated Calcium Channel (VGCC) Antibody RIA Assay Kit Regulation Number: 21 CFR §866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: II Product Codes: PAF
Dated: May 2, 2012
Received: May 3, 2012
Dear Ms. Viele:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice
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Page 2 - Ms. Heather Viele
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Reena Philip
0 tr Maria Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): To be assigned by FDA
Device Name:
KRONUS Voltage Gated Calcium Channel (VGCC) Antibody RIA Assay Kit
Indications for Use Statement:
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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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Pursuant to 21 CFR 801.109)
OR
Over-the-counter Use
Kaire Sommitt
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510K k 111956
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).