(50 days)
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No
The summary describes a chemical reagent kit for measuring blood urea nitrogen (BUN) levels using a standard laboratory system (SYNCHRON CX 3 System). There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on standard analytical chemistry metrics like correlation, precision, and linearity.
No
This device is a diagnostic reagent designed to measure blood urea nitrogen (BUN) levels to evaluate kidney function, not to treat or alleviate a disease or condition.
Yes
The device is used to determine blood urea nitrogen (BUN) levels, which helps in evaluating kidney function and diagnosing various related conditions. This indicates its use in the diagnosis of diseases or conditions.
No
The device is a reagent kit intended for use with a specific hardware system (SYNCHRON CX 3 System), indicating it is a chemical component, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for the "determination" of blood urea nitrogen (BUN) levels, which is a "screening procedure for evaluating kidney function." This involves testing a sample taken from the human body (blood).
- Device Description: The device is a "Reagent," which is a substance used in a chemical reaction to detect, measure, or produce other substances. In this case, it's used to measure BUN in a blood sample.
- Performance Studies: The document describes performance studies conducted with "serum samples," which are derived from blood.
- Predicate Device: The mention of a "Predicate Device" which is a "BUN Reagent Kit" further confirms its nature as a diagnostic test kit.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The level of blood urea nitrogen (BUN) is regulated by the metabolism of proteins and by the renal excretion of urea.1 BUN determination, therefore, has become the most widely used screening procedure for evaluating kidney function. Increased BUN levels occur in cases of impaired kidney function such as chronic nephritis, acute glomerulonephritis, polycystic disease of the kidney, nephrosclerosis and tubular necrosis.2 BUN levels are also elevated due to urinary tract obstruction and during the terminal stage of liver disease. Decrease in BUN levels often accompany primary hepatic insufficiency and acute hepatitis.
Product codes
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Device Description
In 1961, Chin and Kroontje reported a method for determining urea based upon the difference in conductivity of urea and the ammonium bicarbonate produced by urease form urea.3 In 1971, the method was modified to detect urea by measuring the rate of increase of conductivity.4 The Sigma Diagnostics BUN Reagent is formulated to use this methodology on the SYNCHRON CX 3 System.
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
In a comparison study, a correlation coefficient of 0.999 and a regression equation of y = 1.03x - 0.19 was obtained with serum samples. With-in run precision and total precision on serum samples demonstrated %CV's of less than 4%. The Sigma Diagnostics BUN Reagent has been determined to be linear to 125 mg/dL.
Key Metrics
correlation coefficient of 0.999, regression equation of y = 1.03x - 0.19, %CV's of less than 4%, linear to 125 mg/dL.
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
OCT 2 4 996
510(K) NOTIFICATION
Sigma Diagnostics 545 South Ewing Avenue St. Louis, MO 63103
CX®3 BUN Reagent Procedure Number B1657 August 31, 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
The level of blood urea nitrogen (BUN) is regulated by the metabolism of proteins and by the renal excretion of urea.1 BUN determination, therefore, has become the most widely used screening procedure for evaluating kidney function. Increased BUN levels occur in cases of impaired kidney function such as chronic nephritis, acute glomerulonephritis, polycystic disease of the kidney, nephrosclerosis and tubular necrosis.2 BUN levels are also elevated due to urinary tract obstruction and during the terminal stage of liver disease. Decrease in BUN levels often accompany primary hepatic insufficiency and acute hepatitis.
In 1961, Chin and Kroontje reported a method for determining urea based upon the difference in conductivity of urea and the ammonium bicarbonate produced by urease form urea.3 In 1971, the method was modified to detect urea by measuring the rate of increase of conductivity.4 The Sigma Diagnostics BUN Reagent is formulated to use this methodology on the SYNCHRON CX 3 System.
The safety and effectiveness of Sigma Diagnostics BUN Reagent, Procedure Number B1657, are demonstrated by its substantial equivalency to Beckman BUN Reagent Kit, Part No. 443350. Both reagents are used to measure BUN concentrations in serum or plasma on the SYNCHRON CX 3 System, and the reaction principles for both are identical. In a comparison study, a correlation coefficient of 0.999 and a regression equation of y = 1.03x - 0.19 was obtained with serum samples. With-in run precision and total precision on serum samples demonstrated %CV's of less than 4%. The Sigma Diagnostics BUN Reagent has been determined to be linear to 125 mg/dL.
REFERENCES
- 1 . Cantarow A Trumper M: Clinical Biochemistry, WB Saunders Company, Philadelphia, 1975. pp 207-209
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- Tietz NW: Fundamentals of Clinical Chemistry, WB Saunders Company, Philadelphia, 1976, p 993
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- Textbook of Clinical Chemistry, NW Tietz, Editor, WB Saunders Company, Philadelphia. 1986
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- Chin WT, Kroontje W: Anal Chem 33:1757, 1961