RANDOX CREATININE

K973993 · Randox Laboratories, Ltd. · CGX · Mar 6, 1998 · Clinical Chemistry

Device Facts

• Record ID: K973993
• Device Name: RANDOX CREATININE
• Applicant: Randox Laboratories, Ltd.
• Product Code: CGX · Clinical Chemistry
• Decision Date: Mar 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended 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.

Device Story

Randox Creatinine Test Kit is an in vitro diagnostic reagent for quantitative creatinine measurement in human serum and plasma. Principle of operation: Jaffe reaction; creatinine reacts with picrate in alkaline environment to form colored complex. Used in clinical laboratories by qualified personnel. Output: quantitative creatinine concentration. Clinical utility: assessment of kidney function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent kit. Principle: Jaffe reaction (colorimetric). Analyte: Creatinine. Sample matrix: Human serum and plasma.

Indications for Use

Indicated for the quantitative determination of creatinine in human serum and plasma to assess kidney function. For use by qualified laboratory personnel in clinical laboratory settings.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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| 510(k) Number (if known) | NOT KNOWN 973993 |
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| 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) |
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(Division Sign-Off)

Division of Clinical Laboratory Devices
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Division of Clinical
510(k) Number ___________________________________________________________________________________________________________________________________________