(25 days)
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No
The document contains no mention of AI, ML, or related concepts, and the device description is not available to infer such capabilities.
No
The device is for "IN VITRO diagnostic use" and is intended to "measure urea nitrogen in serum" for diagnosis, not for treating diseases, which is the function of a therapeutic device.
Yes
The "Intended Use / Indications for Use" section states that the measurements obtained by this device are "used in the diagnosis and treatment of certain renal and metabolic diseases." This directly indicates its role in diagnosis.
No
The intended use clearly states "For IN VITRO diagnostic use" and describes a "test system" for measuring urea in serum. This strongly implies a physical device that interacts with a biological sample, not a software-only device. The lack of a device description prevents definitive confirmation, but the intended use points away from a software-only classification.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "For the quantitative determination of urea in serum." This indicates the device is used to analyze a biological sample (serum) outside of the body.
- "For IN VITRO diagnostic use." This is a direct declaration that the device is intended for in vitro diagnostic purposes.
The description of the device's function further supports this:
- "A urea nitrogen test system is a device intended to measure urea nitrogen... in serum." This reinforces that the device is used to perform a test on a biological sample.
- "Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases." This clarifies that the results of the test are used for diagnostic purposes.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For the quantitative determination of urea in serum. For IN VITRO diagnostic use.
A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in serum. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
Product codes
CDQ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 8 1999
Ms. Karen Callbeck, R.T. B.Sc. Regulatory Affairs Coordinator Diagnostics Chemicals Limited 16 McCarville Street Charlottetown, P.E.I., Canada
Re: : K993178 Trade Name: Urea-L3K Assay Regulatory Class: II Product Code: CDQ Dated: September 21, 1999 Received: September 23, 1999
Dear Ms. Callbeck:
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/cdrlv/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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): K 993178
Device Name: Urea-L3K
Indications for Use:
For the quantitative determination of urea in serum. For IN VITRO diagnostic use.
A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in serum. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
tean
Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993178
(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 Fennat 1-2-96)