(136 days)
The Randox Laboratories Limited Creatinine Test Kit is an in vitro diagnostic reagent for the quantitative determination of creatinine in human serum and plasma. The method is based on the reaction of creatinine with picrate in an alkaline environment (Jaffe) to produce a coloured complex. Creatinine is measured primarily to assess kidney function.
The Randox Laboratories Limited Creatinine Test Kit is an in vitro diagnostic reagent for the quantitative determination of creatinine in human serum and plasma. The method is based on the reaction of creatinine with picrate in an alkaline environment (Jaffe) to produce a coloured complex.
The provided text is a 510(k) premarket notification letter from the FDA regarding a Creatinine test kit. It acknowledges the device is substantially equivalent to legally marketed predicate devices. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
FDA 510(k) clearance primarily focuses on demonstrating substantial equivalence to a predicate device, not necessarily on presenting a detailed performance study against predefined acceptance criteria in the format requested. While the manufacturer (Randox Laboratories) would have conducted studies to demonstrate the device's performance for their 510(k) submission, the provided FDA letter and enclosed "Indications For Use" statement do not include the specific details about those studies, such as sample size, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested information based solely on the text provided. The document confirms the FDA clearance but doesn't detail the underlying performance data and how it met acceptance criteria.
If such information were present in a different document (e.g., the actual 510(k) summary submitted by Randox Laboratories), I would be able to extract it.
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Image /page/0/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which is a stylized image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the seal.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR - 6 1998
Dr. P. Armstrong · Requlatory Affairs Randox Laboratories, Ltd. Ardmore, Diamond Road Crumlin, Co., Antrim United Kingdom, BT29 4QY
Re : K973993 Randox Creatinine Requlatory Class: II Product Code: CGX Dated: February 16, 1998 Received: February 18, 1998
Dear Dr. Armstrong:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with" " " the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note:
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 0 | |||
|---|---|---|---|
| - |
| 510(k) Number (if known) | NOT KNOWN 973993 |
|---|---|
| Device Name | CREATININE |
Indications For Use :
The Randox Laboratories Limited Creatinine Test Kit is an in vitro diagnostic reagent for the quantitative determination of creatinine in human serum and plasma. The method is based on the reaction of creatinine with picrate in an alkaline environment (Jaffe) to produce a coloured complex. Creatinine is measured primarily to assess kidney function.
This test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional format 1-2-96) |
|---|---|---|
| --------------------------------------- | ---- | ----------------------------------------------- |
(Division Sign-Off)
Division of Clinical Laboratory Devices
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Division of Clinical
510(k) Number ___________________________________________________________________________________________________________________________________________
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.