(64 days)
The Randox Laboratories Limited Magnesium Test Kit is an in vitro diagnostic reagent for the quantitative determination of magnesium in human serum or plasma. This method uses Xylidyl Blue to measure magnesium. Abnormal concentrations of magnesium (elevated or low) are associated with a variety of clinical conditions.
This test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.
in vitro diagnostic reagent for the quantitative determination of magnesium in human serum or plasma. This method uses Xylidyl Blue to measure magnesium.
I am sorry, but the provided text only contains an FDA clearance letter for the Randox Magnesium Test Kit (K974606) and a page detailing its indications for use. It does not include acceptance criteria, study details, or performance data for the device. Therefore, I cannot fulfill your request for the information outlined.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. P. Armstrong Regulatory Affairs RANDOX LABORATORIES LTD. Ardmore, Diamond Road Crumlin, Co. Antrim UNITED KINGDOM, BT29 4QY
FEB 1 2 1998
Re : K974606 Trade Name: Randox Magnesium Requlatory Class: I Product Code: JGJ 75 Dated: December 08, 1997 Received: December 10, 1997
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 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 of the The general controls provisions of the Act include Act. 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 regulations 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. this response to your premarket notification Please note: 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 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 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
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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| Page of | 1 of 1 |
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| --------- | -------- |
| 510(k) Number (if known) | K974606 - NOT KNOWN |
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| Device Name | MAGNESIUM |
Indications For Use :
i
The Randox Laboratories Limited Magnesium Test Kit is an in vitro diagnostic reagent for the quantitative determination of magnesium in human serum or plasma. This method uses Xylidyl Blue to measure magnesium. Abnormal concentrations of magnesium (elevated or low) are associated with a variety of clinical conditions.
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)
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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional format 1-2-96)
§ 862.1495 Magnesium test system.
(a)
Identification. A magnesium test system is a device intended to measure magnesium levels in serum and plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).(b)
Classification. Class I.