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For the quantitative determination of Blood Urea Nitrogen and creatinine in whole blood. Creatinine values are used as indications of renal function. Blood Urea Nitrogen values are valuable in the diagnosis of renal diseases. For professional in vitro diagnostic use only.

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The provided document is a 510(k) clearance letter from the FDA for a device called "Cholestech BUN/Creatinine Test System II". This document does not contain the detailed information necessary to answer all the questions about acceptance criteria and study design as typically found in a clinical study report or a more comprehensive summary of safety and effectiveness.

However, based on the information available in the document, here's what can be deduced, along with what cannot be provided:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in this document. 510(k) clearances are based on substantial equivalence, meaning the new device performs as well as, or better than, a legally marketed predicate device. The specific performance criteria (e.g., accuracy, precision targets) that Cholestech had to meet are not detailed here. They would typically be found in the 510(k) submission itself.
• Reported Device Performance: Not detailed in this clearance letter. The letter only states that the FDA "determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." This implies that performance data was submitted and found acceptable, but the actual data (e.g., bias, CV, correlation) is not presented.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• This information is not available in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This information is not applicable as this is an in vitro diagnostic device, not an imaging device requiring expert interpretation for ground truth. For IVD devices, ground truth is typically established using a reference method or a well-characterized predicate device. The number and qualifications of individuals performing these reference tests are not in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• This information is not applicable for an in vitro diagnostic device in the context of expert consensus/adjudication. If adjudication refers to discrepancy resolution between the new device and a reference method, that detail is not provided.

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

• This information is not applicable as this is an in vitro diagnostic device, not an AI-powered diagnostic imaging interpretation device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This device is an in vitro diagnostic test system that provides quantitative results. Its "standalone performance" would be its analytical performance (accuracy, precision, linearity, etc.) when tested in a laboratory setting. The specific results of such standalone performance are not detailed in this document. The indications for use state "For professional in vitro diagnostic use only," implying it's used by human operators, but the "performance" is of the device/reagent system itself, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For an in vitro diagnostic device like the Cholestech BUN/Creatinine Test System II, the "ground truth" for determining its performance (e.g., accuracy) would typically be established by:
  • Reference laboratory methods: Assays performed in a high-complexity laboratory using established, often more expensive or time-consuming, gold standard methods for BUN and Creatinine.
  • Predicate device comparison: Directly comparing results from the new device with a legally marketed predicate device on the same patient samples.
• The document does not specify which type of ground truth was used for their submission.

8. The sample size for the training set

• This information is not available in the provided document. The concept of a "training set" is more directly relevant to machine learning/AI development, though IVD systems also involve extensive development and testing with samples.

9. How the ground truth for the training set was established

• This information is not available in the provided document. Similar to point 7, it would likely involve reference methods or predicate device comparison if a training phase (e.g., for algorithm development in a more complex IVD) was explicitly conducted.

Summary of available information from the document:

• Device Name: Cholestech BUN/Creatinine Test System II
• Intended Use: Quantitative determination of Blood Urea Nitrogen and Creatinine in whole blood. Creatinine values are used as indications of renal function. Blood Urea Nitrogen values are valuable in the diagnosis of renal diseases. For professional in vitro diagnostic use only.
• Regulatory Outcome: Found "Substantially Equivalent" (K972012) to a predicate device.
• Regulatory Class: Not explicitly stated in the letter, but implied as a general controls device with potential for additional controls if Class II or III.
• Product Code: CDN, JFY
• Date of Clearance: July 24, 1997

To obtain the detailed information requested, one would typically need to refer to the full 510(k) submission document or a summary of safety and effectiveness (SSE) for K972012, which are sometimes publicly available through the FDA website but are not part of this clearance letter.

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