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The intended use for the N-ASSAY L AST/GOT Reagent is for the quantitative determination of serum aspartate aminotransferase (AST) activity in human serum in the diagnosis and treatment of certain types of liver, heart, and muscle diseases. For in vitro diagnostic use only.

The N-ASSAY L AST/GOT reagent is based on an the optimized enzymatic AST kinetic method as recommended by the Japan Society of Clinical Chemistry, shows good correlation with similar AST reagents, practically no interference by coexistent substances, high sensitivity with good reproducibility, wide assay range, and is convenient ready-to-use liquid type reagent.

In this procedure, L-Aspartic Acid and a-Ketoglutaric Acid are translated by aspartate aminotransferase (AST) to produce Oxalacetic Acid and Glutamic Acid. Oxalacetic Acid is reduced by Malic Dehydrogenase to produce Malic Acid with the concurrent oxidation of nicotinamide adenine dinucleotide reduced (NADH) to nicotinamide adenine dinucleotide (NAD). The NADH absorbs light at 340 nm (main) and 405 nm (sub) and can be detected spectrophotometrically. The decrease per minute in absorbance measured at 340 nm (main) and 405 (sub), due to the decrease of NADH, is directly proportional to the AST activity in the sample.

The Crestat N-ASSAY L AST/GOT Reagent is an in vitro diagnostic device used for the quantitative determination of serum aspartate aminotransferase (AST) activity in human serum, aiding in the diagnosis and treatment of certain liver, heart, and muscle diseases.

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

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not explicitly state the number of samples used in the comparison studies. It refers to "serum samples" in plural, implying more than one but providing no specific quantity.
• Data Provenance: Not explicitly stated. However, given that it's an in vitro diagnostic device for human serum, it's highly probable the samples were from human patients. The country of origin and whether the data was retrospective or prospective is not mentioned.

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

• The concept of "ground truth" in the context of expert consensus isn't directly applicable here in the same way it would be for image analysis or disease diagnosis. For this device, the "ground truth" for the test set is established by the performance of the predicate device (Boehringer Mannheim Corporation AST liquid reagent). The predicate device itself would have undergone its own validation based on established clinical chemistry methods.
• Therefore, there were no experts explicitly used to establish ground truth for this device's test set in the manner of adjudication. The predicate device's results are considered the reference.

4. Adjudication method for the test set:

• None. Adjudication is typically used when human interpretation of data is involved to establish a consensus ground truth. In this case, the test involved comparing the quantitative results of the new device against a predicate device, which is an objective measurement comparison.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. An MRMC study is not relevant for this type of quantitative diagnostic assay. MRMC studies are primarily for evaluating the diagnostic performance of human readers, often with and without AI assistance, especially in image-based diagnostics. This study focuses on the analytical performance of a chemical reagent.

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

• Yes, this was a standalone study. The N-ASSAY L AST/GOT Reagent is a chemical assay, and its performance was evaluated intrinsically by comparing its quantitative results to a predicate device. There is no "human-in-the-loop" component in the direct measurement process being evaluated here, beyond standard laboratory handling and operation.

7. The type of ground truth used:

• The "ground truth" in this context is the results obtained from the predicate device (Boehringer Mannheim Corporation AST liquid reagent). This predicate device itself is considered a well-established and validated method for measuring AST activity.

8. The sample size for the training set:

• The concept of a "training set" in the machine learning sense is not applicable to this chemical reagent. There is no algorithm that is "trained" on data. The reagent's performance is based on its chemical properties and optimized enzymatic method. Therefore, no training set was used.

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

• As there is no training set for this chemical assay, the question of how its ground truth was established is not applicable.

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