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The Intersect CK Reagent is an in-vitro diagnostic product intended for use in the quantitative determination of creatine kinasc in human serum.

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This document is a 510(k) clearance letter from the FDA for a medical device called "CK-NAC Reagent" (K974833). It states that the device is substantially equivalent to a predicate device for the quantitative determination of creatine kinase in human serum.

Since this is an FDA clearance letter and not a detailed study report, it does not contain the specific information requested in your prompt regarding acceptance criteria, sample sizes, expert qualifications, or study methodologies. This type of document confirms regulatory approval based on demonstrating substantial equivalence, but it does not typically publish the full technical details of the underlying performance studies.

Therefore, I cannot provide the requested information based on the provided text.

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HiChem CK/NAC Reagent (product no. 70003) is intended for the quantitation of creatine kinase in serum and n homent of had not headly no room, seevated serum creatine kinase are diseases of the heart and skeletal muscle.

The HiChem CK/NAC Reagent determines creatine kinase by enzymation of adenosine diphosphate in the The rionoment of creatine the sphosphate. The rate of this reaction, and the activity of creatine kinase in the sociment is determined through the measurement of NADH which is formed through a series of linked enzymatic reactions.

The HiChern CK/NAC Reagent is intended to be used either as a manual procedure or on clinical analyzers which can THE HONEY ON WO Treagon IS The reagent is supplied as two liquit-stable components which are combined, ether adomails no roquined manyalance "The reason is to to series CK/NAC Reagent Buffer. The CK/NAC Bubstrate can also be used as a start reagent and combined with the Reagent Buffer following sample addition.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

Device: HiChem CK/NAC Reagent (product no. 70003)
Intended Use: Quantitation of creatine kinase in serum. Elevated serum creatine kinase levels indicate diseases of the heart and skeletal muscle.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several performance characteristics for both manual and automated (Hitachi 704) procedures. The acceptance criteria are implicitly derived from the reported performance, as the document states these demonstrate the effectiveness of the reagent. For linearity and precision, the reported values often serve as the acceptance criteria themselves within the context of demonstrating "effectiveness." For comparison studies and stability, the acceptance criteria are explicitly stated as biases/shifts being below certain thresholds or strong correlation coefficients.

Study that Proves the Device Meets the Acceptance Criteria:

The document itself constitutes the summary of the studies performed to demonstrate safety and effectiveness, and ultimately, substantial equivalence to predicate devices. It describes a series of experiments and analyses for both manual and automated use of the HiChem CK/NAC Reagent.

2. Sample Sizes Used for the Test Set and Data Provenance

• Linearity (Manual): "linearity standards" (number not specified explicitly, but implies multiple points across the range).

• Precision (Manual): 30 replicates per serum control level (3 levels tested).

• Method Comparison (Manual): 90 mixed serum and plasma specimens.

• Chemical Additives (Manual): "spiked and unspiked serum pools" (number of pools/samples not specified, but implies comparative testing).

• Reagent Stability (Manual): "serum controls" (number of controls/data points not specified explicitly, but ranges from 50 to 1200 U/L CK).

• Linearity (Automated): "eleven linearity standards."

• Precision (Automated): 60 replicates per serum control level (3 levels tested).

• Method Comparison (Automated): 126 mixed serum and plasma specimens.

• Calibration Stability (Automated): "serum controls" spanning approximately 50 to 1,200 U/L CK (number of controls/data points not specified explicitly).

• On-board Stability (Automated): "the same serum controls" as for calibration stability (number of controls/data points not specified explicitly).

Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). Given the nature of laboratory reagent testing for product submission, it is typically understood that these are prospective studies conducted in a controlled lab environment.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of study does not involve "experts" establishing ground truth in the traditional sense of medical image interpretation (e.g., radiologists). Instead, the "ground truth" for the test set is established by:

• Reference materials: Known concentration "linearity standards" for linearity testing, "commercially available control sera" with known target values for precision testing.
• Predicate devices: The legally marketed Sigma Diagnostics Creatine Kinase (CK) Reagent and BMD CK/NAC Reagent serve as the reference standard (the "ground truth" or comparative standard) for method comparison studies.

Therefore, the concept of "number of experts" and their "qualifications" is not applicable here.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of interpretations (e.g., by multiple readers). The results are quantitative measurements compared against known values or established predicate methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of images or other subjective data, which is not the case for a quantitative chemical reagent.

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

This is essentially a standalone (algorithm/reagent only) performance study. The reagent itself, combined with either manual pipetting and spectrophotometry or an automated analyzer, generates the results. There isn't a "human-in-the-loop" component in the interpretation of the result from the device, only in the operation of the manual procedure. The automated procedure is even less human-in-the-loop for the measurement process.

7. The Type of Ground Truth Used

The ground truth used several forms:

• Reference Standards/Materials: For linearity, commercially prepared "linearity standards" with known, accurate creatine kinase concentrations are used. For precision, "commercially available control sera" with established target values are used.
• Predicate Device Measurements: For method comparison, the measurements obtained from legally marketed predicate devices (BMD CK/NAC Reagent and Sigma Diagnostics Creatine Kinase (CK) Reagent) on the same patient specimens serve as the comparative ground truth.

8. The Sample Size for the Training Set

Not applicable. This is a chemical reagent, not a machine learning algorithm that requires a "training set." The performance characteristics are derived from direct experimental measurements. The phrase "training set" is generally used in the context of AI/ML model development.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

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