(185 days)
Not Found
Not Found
No
The summary describes a chemical reagent test kit for determining Urea Nitrogen levels. There is no mention of AI, ML, image processing, or any computational analysis beyond standard kinetic measurements.
No
The device is used for the kinetic quantitative determination of Urea Nitrogen (BUN) in serum, which is a diagnostic function, not a therapeutic one. It measures a substance in the body rather than treating a condition.
Yes
The device is used for the kinetic quantitative determination of Urea Nitrogen (BUN) in serum, which is a diagnostic measurement.
No
The device description explicitly states it is a "test kit" comprised of "two reagents" and a "standard," which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "kinetic quantitative determination of Urea Nitrogen (BUN) in serum." This is a test performed on a biological sample (serum) outside of the body to provide information about a patient's health status. This is the core definition of an in vitro diagnostic.
- Device Description: The device is a "test kit" comprised of reagents and a standard. These are components used to perform a diagnostic test on a sample.
- Performance Studies: The description of performance studies (method comparison, precision, linearity, sensitivity, stability, interference) are typical studies performed to validate the performance of an IVD.
- Reference Device: The mention of a "Reference Device" which is another BUN test kit further indicates that this device is intended for diagnostic testing.
Therefore, based on the provided information, this device clearly fits the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The device is used for the kinetic quantitative determination of Urea Nitrogen (BUN) in serum.
Product codes
75CDQ
Device Description
The device test kit is comprised of two reagents, BUN Buffer (R1) and BUN Enzyme (R2), and a standard, 30mg/dL. A working reagent is prepared by combining five parts BUN Buffer (R1) to one part BUN Enzyme (R2).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Substantial equivalency was demonstrated by method comparison. Correlation was performed between the two test kits with a correlation coefficient of 0.999 and a regression equation of y = 1.012x - 0.47. In addition, precision, linearity, sensitivity, stability and interference studies were performed on Stanbio Laboratory, Inc., version of Urea Nitrogen (BUN) Liqui-UV®, Catalog # 2020. Results of these tests were found to be acceptable
Key Metrics
Correlation coefficient of 0.999 and a regression equation of y = 1.012x - 0.47.
Predicate Device(s)
Not Found
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.
0
DEC 26 1996
KGC2418
510(k) SUMMARY
Submitter's Name Kirk Johnson Stanbio Laboratory, Inc. 2930 East Houston Street San Antonio, TX 78202
Tel. (210) 222-2108 Fax (210) 227-6367
Prepared By Kirk Johnson June 18, 1996
Product Name Trade name-Urea Nitrogen (BUN) Liqui-UV® Common name-Urea Nitrogen (BUN) Classification name-Urease and Glutamic Dehydrogenase, Urea Nitrogen Class II, 75CDQ
7:14
Substantial Equivalence of Device This test is substantially equivalent to : Product Name: BUN, UV Urease/GLDH (Kinetic) Manufacturer Boehringer Mannheim
Description of Device
The device test kit is comprised of two reagents, BUN Buffer (R1) and BUN Enzyme (R2), and a standard, 30mg/dL. A working reagent is prepared by combining five parts BUN Buffer (R1) to one part BUN Enzyme (R2).
Intended Use of Device
The device is used for the kinetic quantitative determination of Urea Nitrogen (BUN) in serum.
Comparison of Devices Both Urea Nitrogen (BUN) methods measure kinetically the decrease in absorbance due to consumption and conversion of NADH to NAD.
Performance Data
Substantial equivalency was demonstrated by method comparison. Correlation was performed between the two test kits with a correlation coefficient of 0.999 and a regression equation of y = 1.012x - 0.47.
In addition, precision, linearity, sensitivity, stability and interference studies were performed on Stanbio Laboratory, Inc., version of Urea Nitrogen (BUN) Liqui-UV®, Catalog # 2020. Results of these tests were found to be acceptable