(34 days)
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No
The summary describes a reagent for a chemical test, not a device that processes data or images using AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is intended for in vitro diagnostic (IVD) use to measure a substance for clinical diagnosis, not to directly treat a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "Intended for the In Vitro, quantitative determination of Urea Nitrogen) in human serum and urine for clinical diagnosis." and that "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 device description explicitly states "TRACE Urea (Urea Nitrogen) - DST Reagent," indicating it is a reagent, which is a chemical substance used in a test, not a software-only device. The intended use also describes an "In Vitro, quantitative determination," further suggesting a laboratory test involving physical components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Intended for the In Vitro, quantitative determination of Urea Nitrogen) in human serum and urine for clinical diagnosis." The phrase "In Vitro" is a key indicator of an IVD.
- CFR Reference: The description includes a reference to CFR 862.1770, which is the regulation for Urea Nitrogen test systems, a type of IVD.
- Purpose: The purpose described is to measure a substance in human biological samples (serum, plasma, and urine) for use in clinical diagnosis and treatment. This is the core function of an IVD.
N/A
Intended Use / Indications for Use
Intended for the In Vitro, quantitative determination of Urea Nitrogen) in human serum and urine for clinical diagnosis.
"This Urea (Urea Nitrogen) test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases." CFR 862.1770
Product codes
CDO
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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 27 1997
David Johnston · Technical Director TRACE America, Inc. 7260 North West 58th Street Miami, Florida 33166
Re : K971477 Urea Nitrogen Requlatory Class: I Product Code: CDO Dated: April 7, 1997 Received: April 23, 1997
Dear Mr. Johnston:
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 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 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 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 deyice 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 diaqnostic 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 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/dsmamain.html".
Sincerely yours,
Steven Gutman
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): | (to be assigned) |
|---|---|
| Device Name: | TRACE Urea (Urea Nitrogen) - DST Reagent |
Indications for Use:
Intended for the In Vitro, quantitative determination of Urea Nitrogen) in human serum and urine for clinical diagnosis.
"This Urea (Urea Nitrogen) test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases." CFR 862.1770
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (QDE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Numiber 971447
Prescription Use _ (Per 21 CFR 801.109) OR
Over-The-Counter Use _
(Optional Format 1-2-96)