(258 days)
The KRONUS 21-Hydroxylase Antibody (21-OHAb) RIA Assay Kit is for the semiquantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The KRONUS Steroid 21-OHAb RIA Assay may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.
Not Found
The provided document describes a 510(k) premarket notification for a medical device, specifically the KRONUS Steroid 21-Hydroxylase Antibody (21-OHAb) RIA Assay Kit. It establishes substantial equivalence to a predicate device, but does not contain the information required to answer your specific questions about acceptance criteria and proof of performance through a study.
The document is a regulatory approval letter from the FDA, confirming that the device can be marketed. It details the device name, regulation number, regulatory class, product code, and indications for use. Key information like sample sizes, ground truth establishment, expert qualifications, and detailed study results are typically found in the submission itself, which is not provided here.
Therefore, I cannot provide the requested information based solely on the text you've given me. To answer your questions, I would need access to the actual 510(k) submission data, specifically the sections that detail the validation studies and performance data.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
DEC 2 0 2012
KRONUS Market Development Associates Inc. C/O Ms. Tanis Jimenez Quality Control and Regulatory Compliance Manager 170 Seneca Springs Way, Suite 105 Star, ID 83669
Re: K121046
Trade/Device Name: Steroid 21-Hydroxylase Antibody (21-OHAb) RIA Assay Kit Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple autoantibody immunological test system Regulatory Class: Class II Product Code: PCG Dated: December 18, 2012 Received: December 19, 2012
Dear Ms. Jimenez:
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 udications 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 FederallFound, Dr 10 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. Please note: CDRH does not evaluate information related to contractly allity warranties. We remind you, however, that device labeling must be truthful and not micleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA over 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 af 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 Part 801); medical device reporting (reporting of medical
{1}------------------------------------------------
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Maria M. Chan
Maria M. Chan, Ph.D. Director
Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological
Health (OIR)
Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number: K121046
Device Name: KRONUS Steroid 21-Hydroxylase Antibody (21-OHAb) RIA Assay Kit
Indications For Use:
The KRONUS 21-Hydroxylase Antibody (21-OHAb) RIA Assay Kit is for the semiquantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The KRONUS Steroid 21-OHAb RIA Assay may be useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
Mana M. Alain
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121046
§ 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).