(175 days)
The KRONUS Insulin Autoantibody RIA Assay Kit is for the semi-quantitative determination of antibodies to insulin in human serum. The KRONUS Insulin Autoantibody RIA Assay is useful as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy.
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This document is a 510(k) premarket notification letter from the FDA to KRONUS Market Development Associates, Inc. for their Insulin Autoantibody RIA Kit. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria.
The letter only states that the device is "substantially equivalent" to predicate devices, which is the basis for its clearance for market. It refers to "indications for use" but does not provide performance metrics or study details.
Therefore, I cannot extract the requested information from the provided text.
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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. The eagle is facing to the right, and the text is arranged in a clockwise direction around the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
KRONUS Market Development Associates, Inc. c/o Ms. Heather Viele Director of Technical Affairs 12554 West Bridger Street, Suite 108 Boise, ID 83713
JUL 1 3 2007
Re: K070183
Trade/Device Name: KRONUS Insulin Autoantibody RIA Kit Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: Class II Product Code: OCN Dated: May 31, 2007 Received: June 1, 2007
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 either class II (Special Controls) or class III (PMA), it may be subject to such 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 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 Part 801); good manufacturing practice 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
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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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert H. Beckerf
Robert L. Becker, Jr., M.D., 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
K070183 510(k) Number (if known): Fo be assigned by FDA
Device Name:
KRONUS Insulin Autoantibody (IAA) RIA Assay Kit
Indications for Use Statement: .
The KRONUS Insulin Autoantibody RIA Assay Kit is for the semi-quantitative determination of antibodies to insulin in human serum. The KRONUS Insulin Autoantibody RIA Assay is useful as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy.
(Please Do Not Write Below This Line - Continue On another Page If Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Pursuant to 21 CFR 801.109)
OR
Over-the-counter Use
Mana m Chan
Division Sign-Off
Office of In Vitro Diag Device Eyaluation and S
510(k) Ko70/63
KRONUS IAA RIA Assay Kit Premarket Notification January, 2007
§ 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).