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Diazyme Creatinine Liquid Reagents Assay, in conjunction with Diazyme Creatinine Calibrator, is intended for the quantitative determination of creatinine in serum and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. For in vitro diagnostic use only.

Diazyme Creatinine Control is an assayed QC material for use in quantitative in vitro diagnostic determination of creatinine in human serum and urine. It is intended as a reference sample for monitoring the Diazyme Creatinine Liquid Reagents Assay for gross systematic errors. For in vitro diagnostic use only.

This enzymatic assay for creatinine involves a series of coupled enzymatic reactions including creatininase enzymatic conversion of creatinine into the product creatine. which itself is converted to sarcosine by creatine amidinohydrolase (creatinase), followed by oxidation of sarcosine by sarcosine oxidase (SOD) producing hydrogen peroxide. In the presence of peroxidase (POD) the hydrogen peroxide is quantified at 550mm by the formation of a colored dye.

Here's an analysis of the Diazyme Creatinine Assay based on the provided 510(k) summary, structured to address your specific questions:

Device: Diazyme Creatinine Liquid Reagents Assay

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device, Roche Creatinine Plus (K003261). The study aims to demonstrate substantial equivalence, meaning its performance characteristics should be similar to or better than the predicate's.

The "Equivalency" column in the original document is based on a direct comparison of characteristics, essentially serving as a statement of acceptance criteria by the submitter. The document explicitly states: "The minor differences in the performances of the tests should not affect the safety and effectiveness of the Diazyme Creatinine Liquid Reagents Assay and offers users a rapid device to measure creatinine in human serum."

1. Sample sizes used for the test set and the data provenance:

• Accuracy/Recovery Studies:
  • Serum samples: 11 samples were used for analytical recovery.
  • Urine samples: 22 samples were used for analytical recovery.
• Interference studies: "Pooled human serum and urine" were used for testing. Specific number of samples beyond "pooled" is not provided.
• Precision studies: Not explicitly stated as "test set" samples, but these are performance characteristics based on multiple measurements of specific samples/concentrations.
  • For serum: Measurements at 4 concentrations (0.75, 1.41, 3.91, 10.28 mg/dL).
  • For urine: Measurements at 3 concentrations (30, 87.13, 196.70 mg/dL).
• Provenance: The document ("510(k) Summary") does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that it's a pre-market submission, these performance tests are typically prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This device is an in vitro diagnostic (IVD) assay for measuring a specific biomarker (creatinine). The "ground truth" for such assays is established by reference measurement procedures or highly accurate predicate devices, not by expert consensus (like in image analysis).
• The ground truth in this study was established using the Roche Creatinine Plus (K003261) predicate device. No human experts were involved in establishing the ground truth for the numeric values of creatinine.

3. Adjudication method for the test set:

• Not applicable as this is an IVD assay where ground truth is based on a predicate device or reference method, not human interpretation.

4. 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/CAD (Computer-Aided Detection) device meant to assist human readers. It's a standalone in vitro diagnostic assay.

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

• Yes, this was a standalone performance study. The Diazyme Creatinine Liquid Reagents Assay's performance (accuracy, precision, recovery, reportable range, interference) was evaluated as a standalone product and compared directly to the predicate device's performance. There is no human-in-the-loop component for this type of chemical assay.

6. The type of ground truth used:

• The ground truth was established by comparison to a legally marketed predicate device (Roche Creatinine Plus, K003261). This is a common and accepted method for demonstrating substantial equivalence for IVD devices, where the predicate serves as the "truth" for comparison. The predicate itself would have been validated against a reference method (e.g., isotope dilution mass spectrometry (IDMS) or other highly accurate chemical methods).

7. The sample size for the training set:

• Not applicable in the typical sense for machine learning/AI. This is a chemical assay, not an algorithm that requires a "training set" to learn. The assay relies on established biochemical reactions and calibration. The "training" in this context would refer to internal analytical validation and optimization during the assay development process, not a distinct medical data training set for a "model."

8. How the ground truth for the training set was established:

• Not applicable. As explained above, there isn't a "training set" for this type of chemical assay. The system is calibrated, and its ground truth for evaluation is the predicate device's results.

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