No
The device description details a standard clinical chemistry assay based on enzymatic reactions and spectrophotometry. There is no mention of AI, ML, image processing, or any data-driven algorithms typically associated with AI/ML in the provided text. The performance studies focus on traditional analytical metrics like correlation, precision, and linearity.
No
This device is an in vitro diagnostic assay used for quantitation of urea nitrogen to aid in diagnosis and treatment; it does not directly treat a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained by this device are used in diagnosis and treatment of certain renal and metabolic diseases." This directly indicates its diagnostic purpose.
No
The device description clearly outlines a chemical assay process involving enzymatic reactions and spectrophotometric measurements, indicating it is an in vitro diagnostic kit with physical reagents and likely requires a laboratory analyzer, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is used for the quantitation of urea nitrogen in human serum, plasma, or urine, and that the measurements are used in the diagnosis and treatment of certain renal and metabolic diseases. This aligns directly with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The "Device Description" further clarifies that it is an "in vitro diagnostic assay" for the quantitative determination of urea nitrogen in human samples. It describes the chemical reactions involved in the assay, which are performed outside of the body.
- Performance Studies: The "Summary of Performance Studies" describes comparative studies conducted using the assay, which is typical for validating the performance of an IVD.
- Predicate Device: The mention of a "Predicate Device" (K771923; Boehringer Mannheim® Urea Nitrogen assay on the Hitachi® 717 Analyzer) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.
All of these points clearly indicate that this device is designed and intended to be used as an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Urea Nitrogen assay is used for the quantitation of urea nitrogen in human serum, plasma, or urine. Measurements obtained by this device are used in diagnosis and treatment of certain renal and metabolic diseases.
Product codes
75CDQ
Device Description
Urea Nitrogen is an in vitro diagnostic assay for the quantitative determination of urea nitrogen in human serum, plasma, or urine. The Urea Nitrogen assay is a clinical chemistry assay in which the urea in the sample is hydrolyzed by urease to ammonia (NH3) and carbon dioxide (CO2). A second reaction, catalyzed by glutamate dehydrogenase (GLDH), converts ammonia and a-ketoglutarate to glutamate and water with the concurrent oxidation of reduced nicotinamide adenine dinucleotide (NADH) to nicotinamide adenine dinucleotide (NAD). Two moles of NADH are oxidized for each mole of urea present. The initial rate of decrease in absorbance at 340/380 nm is proportional to the urea concentration in the sample.
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)
Comparative performance studies were conducted using the AEROSET™ System. The Urea Nitrogen assay method comparison vielded acceptable correlation with the the Boehringer Mannheim Urea Nitrogen assay on the Hitachi 717 Analyzer for the serum and urine applications. For the serum application, the correlation coefficient = 0.9974, slope = 1.038, and Y-intercept = 0.904 mg/dL. For the urine application, the correlation coefficient = 0.9919, slope = 0.983, and Y-intercept = 9.993 mg/dL. Precision studies were conducted using the Urea Nitrogen assay. Within-run, between-run, and between-day studies were performed using two levels of control material. For the serum application, the total %CV for Level 1/Panel 101 is 1.8% and Level 2/Panel 102 is 2.0%. For the urine application, the total %CV for Level 1/Panel 201 control is 3.8% and Level 2/Panel 202 is 3.1%. The Urea Nitrogen assay is linear up to 234.4 mg/dL for the serum application, and 1,991.1 mg/dL for the urine application. The limit of quantititation (sensitivity) of the Urea Nitrogen assay is 0.9 mg/dL. These data demonstrate that the performance of the Urea Nitrogen assay is substantially equivalent to the performance of the Boehringer Mannheim Urea Nitrogen assay on the Hitachi 717 Analyzer.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation Coefficient (serum): 0.9974
Slope (serum): 1.038
Y-intercept (serum): 0.904 mg/dL
Correlation Coefficient (urine): 0.9919
Slope (urine): 0.983
Y-intercept (urine): 9.993 mg/dL
Total %CV for Level 1/Panel 101 (serum): 1.8%
Total %CV for Level 2/Panel 102 (serum): 2.0%
Total %CV for Level 1/Panel 201 (urine): 3.8%
Total %CV for Level 2/Panel 202 (urine): 3.1%
Linearity (serum): up to 234.4 mg/dL
Linearity (urine): up to 1,991.1 mg/dL
Limit of quantitation (sensitivity): 0.9 mg/dL
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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510(k) Summary
Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
Contact Person Mark Littlefield Section Manager MS 1-8 Regulatory Affairs (972) 518-6062 Fax (972) 753-3367
| Date of Preparation of this Summary: | May 29, 1998 |
|---|---|
| Device Trade or Proprietary Name: | Urea |
| Device Common/Usual Name or Classification Name: | Urea Nitrogen |
| Classification Number/Class: | 75CDQ/Class II |
. •
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________
Test Description:
Urea Nitrogen is an in vitro diagnostic assay for the quantitative determination of urea nitrogen in human serum, plasma, or urine. The Urea Nitrogen assay is a clinical chemistry assay in which the urea in the sample is hydrolyzed by urease to ammonia (NH3) and carbon dioxide (CO2). A second reaction, catalyzed by glutamate dehydrogenase (GLDH), converts ammonia and a-ketoglutarate to glutamate and water with the concurrent oxidation of reduced nicotinamide adenine dinucleotide (NADH) to nicotinamide adenine dinucleotide (NAD). Two moles of NADH are oxidized for each mole of urea present. The initial rate of decrease in absorbance at 340/380 nm is proportional to the urea concentration in the sample.
Urea Nitrogen 510(k) May 29, 1998 BUN.IWD
Section II Page 1
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Substantial Equivalence:
The Urea Nitrogen assay is substantially equivalent to the following device:
- Boehringer Mannheim® Urea Nitrogen assay (K771923) on the Hitachi® 717 . Analyzer.
Both assays yield similar Performance Characteristics.
Similarities:
- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of urea nitrogen. .
- Both assays vield similar clinical results. .
Differences:
- There is a minor difference between the assay range. .
Intended Use:
The Urea Nitrogen assay is used for the quantitation of urea nitrogen in human serum, plasma, or urine.
Performance Characteristics:
Comparative performance studies were conducted using the AEROSET™ System. The Urea Nitrogen assay method comparison vielded acceptable correlation with the the Boehringer Mannheim Urea Nitrogen assay on the Hitachi 717 Analyzer for the serum and urine applications. For the serum application, the correlation coefficient = 0.9974, slope = 1.038, and Y-intercept = 0.904 mg/dL. For the urine application, the correlation coefficient = 0.9919, slope = 0.983, and Y-intercept = 9.993 mg/dL. Precision studies were conducted using the Urea Nitrogen assay. Within-run, between-run, and between-day studies were performed using two levels of control material. For the serum application, the total %CV for Level 1/Panel 101 is 1.8% and Level 2/Panel 102 is 2.0%. For the urine application, the total %CV for Level 1/Panel 201 control is 3.8% and Level 2/Panel 202 is 3.1%. The Urea Nitrogen assay is linear up to 234.4 mg/dL for the serum application, and 1,991.1 mg/dL for the
Section II Page 2
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urine application. The limit of quantititation (sensitivity) of the Urea Nitrogen assay is 0.9 mg/dL. These data demonstrate that the performance of the Urea Nitrogen assay is substantially equivalent to the performance of the Boehringer Mannheim Urea Nitrogen assay on the Hitachi 717 Analyzer.
Conclusion:
The Urea Nitrogen assay is substantially equivalent to the Boehringer Mannheim Urea Nitrogen assay on the Hitachi 717 Analyzer as demonstrated by results obtained in the studies.
Urea Nitrogen 510(k) May 29, 1998 BUN JWD
Section II Page 3
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Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized human figure with three wavy lines extending from its head. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
JUL 28 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mark Littlefield Section Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038
K981918 Re : Urea Requlatory Class : II Product Code: CDO Dated: May 29, 1998 Received: June 1, 1998
Dear Mr. Littlefield:
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 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 requlations 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 General regulation (21 CFR Part 820) and that, Devices: 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 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.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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Urea Nitrogen ________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Urea Nitrogen assay is used for the quantitation of urea nitrogen in human serum, plasma, or urine. Measurements obtained by this device are used in diagnosis and treatment of certain renal and metabolic diseases.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 4981918
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Congurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)
000000000