(248 days)
A radioimmunoassay for the quantitative in vitro diagnostic measurement of the level of renin in plasma. Renin measurements are used in the diagnosis and treatment of certain types of hypertension.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a Renin RIA Test. This document does not describe acceptance criteria, device performance, or details of a study that proves the device meets specific acceptance criteria in the way described in the request (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies). It is a regulatory approval letter for an in vitro diagnostic device, not a technical report on its performance validation.
Therefore, I cannot extract the requested information from the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
CIS Bio International c/o Mr. Gary Lehnus Lehnus & Associates Consulting 150 Cherry Lane Road East Stroudsburg, PA 18301
MAR 3 0 2007
K062120 Trade/Device Name: Cisbio Renin RIA Test Regulation Number: 21 CFR& 862.1085 Regulation Name: Angiotensin I and renin test system Regulatory Class: Class II Product Code: CIB Dated: February 07, 2007 Received: February 12, 2007
Dear Mr. Lehnus:
Re:
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. Iisting 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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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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 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) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean m. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology 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): K062-120
Cisbio Renin III RIA Test Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
A radioimmunoassay for the quantitative in vitro diagnostic measurement of the level of renin in plasma. Renin measurements are used in the diagnosis and treatment of certain types of hypertension.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safe SIC(k)
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§ 862.1085 Angiotensin I and renin test system.
(a)
Identification. An angiotensin I and renin test system is a device intended to measure the level of angiotensin I generated by renin in plasma. Angiotensin I measurements are used in the diagnosis and treatment of certain types of hypertension.(b)
Classification. Class II.