(21 days)
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No
The summary describes a liquid reagent for a kinetic method to determine Urea Nitrogen, which is a standard laboratory test and does not mention any AI or ML components.
No.
The device is a reagent used for the quantitative determination of Urea Nitrogen, which is an indicator for diagnostic purposes, not for treating a condition.
Yes
This device, a Urea Nitrogen (BUN) Liquid Reagent, is used for the "Kinetic Quantitative determination of Urea Nitrogen (MUN) in serum." This determination is explicitly stated as an "indicator of liver and kidney functions," and used to identify conditions like "Mephritis, Acute Liver Destruction and Urinary Obstruction." These are all diagnostic purposes, aimed at identifying the presence or state of disease.
No
The device description clearly states "Urea Nitrogen (BUN) Liquid Reagent - Kinetic Method," indicating a chemical reagent, which is a physical component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "For the Kinetic Quantitative determination of Urea Nitrogen (MUN) in serum." This indicates the device is used to analyze a biological sample (serum) outside of the body (in vitro) to obtain diagnostic information (urea nitrogen levels as an indicator of liver and kidney function).
- Device Description: The description "Urea Nitrogen (BUN) Liquid Reagent - Kinetic Method" further supports this. Reagents used for analyzing biological samples are a common component of IVD devices.
The information provided aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For the Kinetic Quantitative determination of Urea Nitrogen (MUN) in serum. Urea Nitrogen determination is an indicator of liver and kidney functions, such as; Mephritis, Acute Liver Destruction and Urinary Obstruction.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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 seal of the Department of Health & Human Services - USA. The seal features a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an eagle emblem with stylized feathers.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 16 1998
Rhoda Filipina . Official FDA Correspondent Teco Diagnostics 4925 E. Hunter Avenue Anaheim, California 92807
Re: K981106 Urea Nitrogen (BUN) Liquid Reagent Set Requlatory Class: II Product Code: CDQ Dated: March 18, 1998 Received: March 26, 1998
Dear Ms. Filipina:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral 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. 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 In addition, FDA may publish further announcements action. 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 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 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/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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510(k) Number (if known):_ Urea Nitrogen (BUN) Liquid Reagent - Kinetic Method Device Name: Indications For Use:
For the Kinetic Quantitative determination of Urea Nitrogen (MUN) in serum. Urea Nitrogen determination is an indicator of liver and kidney functions, such as; Mephritis, Acute Liver Destruction and Urinary Obstruction.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaiuation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
(Optional Format 1-2-96)
Over-The-Counter Use
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(Division Sign-Off)
Division of Climcal Laboratory Devices,
510(k) Number K981106