(101 days)
This Magnesium procedure is invitro Diagnostic use in the automated, quantitative determination of Magnesium in serum. Magnesium measurements are use in the diagnostics and treatment of hypomagnesemia (abnormally low levels of serum magnesium) and hypermagnesimia (abnormally high levels of serum magnesium).
Not Found
Unfortunately, the provided text does not contain the specific information needed to answer your request. The document is a 510(k) clearance letter from the FDA for a "Magnesium" diagnostic device, indicating its substantial equivalence to a predicate device for the in vitro quantitative determination of magnesium in serum.
However, it does not provide details about:
- Acceptance criteria and reported device performance: This letter confirms clearance, but doesn't detail the performance metrics.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, or type of ground truth for the test set. These are typically found in the summary of safety and effectiveness, clinical study reports, or validation documents, which are not included here.
- Sample size for the training set or how its ground truth was established. This information is also absent from the provided FDA clearance letter.
To answer your questions, you would need access to the actual 510(k) submission, specifically the sections dealing with device performance studies and validation.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP -2 1993
A.P. Total Care, Inc. c/o Mr. Luis P. Leon Catachem, Inc. 70 Hawley Avenue P.O. Box 6216 Bridgeport, Connecticut 06606
Re: K991761 Trade Name: Magnesium Regulatory Class: II Product Code: JGJ Dated: July 12, 1999 Received: July 26, 1999
Dear Mr. Leon:
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 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). 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 (Premarket Approval), 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 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 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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): K991761
DEVICE NAME: MAGNESIUM
INDICATIONS FOR USE:
This Magnesium procedure is invitro Diagnostic use in the automated, quantitative determination of Magnesium in serum. Magnesium measurements are use in the diagnostics and treatment of hypomagnesemia (abnormally low levels of serum magnesium) and hypermagnesimia (abnormally high levels of serum magnesium).
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices 1991761 510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (OED)
Prescription Use (Per 21 CFR 801.109
ﻨﺪ
OR
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.