(20 days)
BUN Reagent is intended for the quantitative determination of urea nitrogen in serum using Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of certain renal and metabolic diseases.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding a Blood Urea Nitrogen (BUN) Reagent. This document is a regulatory approval letter for an in vitro diagnostic (IVD) device, not an AI/ML medical device. Therefore, the specific questions regarding acceptance criteria, study details, ground truth, and expert involvement for AI/ML performance evaluation are not applicable to this document.
The letter explicitly states: "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)."
This indicates a process of demonstrating substantial equivalence to a predicate device, which relies heavily on comparing the new device's characteristics and performance to an already legally marketed device, often through analytical and clinical performance studies specific to IVDs (e.g., precision, accuracy, linearity, interferences).
Therefore, I cannot provide the requested information as it pertains to AI/ML device evaluation, as this document is not about such a device.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 17 1997
Cynthia Shuqart · President Carolina Liquid Chemistries Corporation 451 West Lambert Road, Suite 207 Brea, California 92821
- K971967 Re : BUN Reagent Requlatory Class: II Product Code: CDQ Dated: May 26, 1997 May 28, 1997 Received:
Dear Ms. Shugart:
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 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 Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 Reqister. 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 requlations.
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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 requlation (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.qov/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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K971967 510(k) Number (if known):
Device Name: Blood Urea Nitrogen (BUN) Reagent
Indications For Use:
BUN Reagent is intended for the quantitative determination of urea nitrogen in serum using Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of certain renal and metabolic diseases.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Veronica Calvin for Dr Montameus.f
(Division Sign-Off)
Division of Clinical Laborat
ces
510(k) Number 297961
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
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§ 862.1770 Urea nitrogen test system.
(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.