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510(k) Data Aggregation
(50 days)
SIGMA DIAGNOSTICS BUN REAGENT
The level of blood urea nitrogen (BUN) is regulated by the metabolism of proteins and by the renal excretion of urea. 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. 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.
The Sigma Diagnostics BUN Reagent is formulated to use this methodology on the SYNCHRON CX 3 System.
This document describes a diagnostic reagent, the Sigma Diagnostics BUN Reagent, and its performance in measuring blood urea nitrogen (BUN) levels. It is not an AI/ML device, and therefore several of the requested categories are not applicable. I will provide information for the relevant categories based on the provided text.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalency to Beckman BUN Reagent Kit | Achieved; "The safety and effectiveness of Sigma Diagnostics BUN Reagent... are demonstrated by its substantial equivalency to Beckman BUN Reagent Kit, Part No. 443350." |
| Identical Reaction Principles | Achieved; "reaction principles for both are identical." |
| Correlation Coefficient (vs. Beckman BUN Reagent Kit) | 0.999 |
| Regression Equation (vs. Beckman BUN Reagent Kit) | y = 1.03x - 0.19 |
| Within-run precision (%CV) | Less than 4% |
| Total precision (%CV) | Less than 4% |
| Linearity | To 125 mg/dL |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number of samples. The text mentions "serum samples" were used for the comparison study and precision evaluations.
- Data Provenance: Not specified, but implied to be from clinical laboratory testing given the nature of the device (BUN reagent). Retrospective or prospective is not stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a chemical reagent, not an AI/ML device relying on human interpretation of images or other subjective data. The "ground truth" for this device would be established by reference methods or validated comparative methods.
4. Adjudication method for the test set:
- Not applicable. There is no subjective interpretation involved that would require adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a chemical reagent, not an algorithm. Its performance is measured directly on laboratory analyzers. The "standalone" performance here refers to its ability to accurately measure BUN concentrations.
7. The type of ground truth used:
- The "ground truth" for evaluating the Sigma Diagnostics BUN Reagent's performance was its comparison against the Beckman BUN Reagent Kit, Part No. 443350, which served as the reference or comparative method for establishing substantial equivalency. Reference methods and established clinical chemistry principles form the basis of ground truth for chemical assays.
8. The sample size for the training set:
- Not applicable. Reagents do not have "training sets" in the AI/ML sense. Their formulation and performance are optimized through chemical and analytical development.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set in the AI/ML context for this device.
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