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Catachem, Inc. Bile Acids assay is an In-Vitro diagnostic enzymatic assay for the quantitative determination of total bile acids in human serum. Measurement of bile acids in human serum, and increased reported levels are representative of specific liver disease. For In-Vitro diagnostic use only

Bile Acids Calibrator. (For In-Vitro diagnostic use only) The bile acids assay contains a calibrator designed for the calibration of the Bile Acids method.

Bile Acids Controls (For In-Vitro diagnostic use only) The bile acids assay also contains control Level-I and control Level-II. These controls are designed to monitor the performance of the Bile Acids assay.

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This looks like a 510(k) clearance letter for an In-Vitro Diagnostic (IVD) enzymatic assay for detecting bile acids in human serum. The document explicitly states it's for diagnostic use only.

Given the nature of the device (an IVD assay) and the provided text:

• Acceptance Criteria & Reported Device Performance: These are typically found in the submission itself, not the clearance letter. The letter confirms substantial equivalence, which implies the device met performance criteria comparable to a predicate device. We cannot extract specific numerical acceptance criteria or performance metrics from this document.
• Study Details: Information regarding sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, and training set details are all part of the underlying studies submitted for 510(k) clearance. This information is not present in the clearance letter or the "Indications for Use" statement.

Therefore, I cannot provide a detailed answer to your request based solely on the provided text. The provided document is a regulatory clearance letter, not a scientific study report.

What can be extracted from the document related to the device:

• Device Name: BILE ACIDS (Liquid Reagents)
• Intended Use: In-Vitro diagnostic enzymatic assay for the quantitative determination of total bile acids in human serum.
• Clinical Significance: Measurement of bile acids in human serum, and increased reported levels are representative of specific liver disease.
• Components: Bile Acids Calibrator and Bile Acids Controls (Level-I and Level-II).
• Regulatory Information:
  • Regulation Number: 21 CFR 862.1177
  • Regulation Name: Cholylglycine test system
  • Regulatory Class: Class II
  • Product Code: KWW, JIS, JJX
  • 510(k) Number: K062503
  • Predicate Device: The clearance letter states substantial equivalence to legally marketed predicate devices, but doesn't name them.

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Total Bile Acids Assay is intended for the in vitro quantitative determination of total bile acids (TBA) in human serum samples. Total bile acids are metabolized in the liver and serve as a marker for normal and abnormal liver function. Serum total bile acids are increased in patients with liver disease.

Total Bile Acids Assay contains a bile acid calibrator. The calibrator is design to be used with the assay for the quantitative determination of TBA in serum.

Total Bile Acids Assay has control design to be used with the assay for the quantitative determination of TBA in serum.

The Diazyme's Total Bile Acids assay is a clinical test kit, intended for quantitative determination of total bile acids in serum by an enzymatic method.

The Diazyme's Total Bile Acids assay is comprised of Reagent 2, and a calibrator.

The reagents of the assay kit are stable liquid formulation that allows ease of use coupled with enhanced performance characteristics. In the presence of Thio-NAD, the enzyme 3ox-hydroxysteroid dehydrogenase (3-a-HSD) converts bile acids to 3-keto steroids and Thio-NADH. The reaction is reversible and 3-0-HSD can convert 3-keto steroids and Thio-NADH to bile acids and Thio-NAD. In the presence of excess NADH, the enzyme cycling occurs efficiently and the rate of formation of Thio-NADH is determined by measuring specific change of absorbance at 405nm.

Here's a summary of the acceptance criteria and the study details for the "Total Bile Acids Assay" device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a tabular format with specific thresholds before presenting the results. Instead, it presents performance characteristics that were likely used to demonstrate substantial equivalence to the predicate device.

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

• Sample Size for Test Set: The document does not specify the exact sample size for the test set used in the correlation study with the predicate device. It mentions testing "clinical patient samples" in the conclusion but doesn't provide a number. For the precision studies, two concentrations (8 μM and 23 μM) were tested, but the number of replicates is not stated. For interference, it states "pooled human sera" were used, but not the number of samples.
• Data Provenance: The document does not explicitly state the country of origin for the data. The studies appear to be retrospective in the sense that they are laboratory performance evaluations rather than new clinical trials with patient recruitment, but this is an inference based on the type of data presented (precision, correlation, interference). There's no indication of prospective clinical study design.

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

This information is not applicable to this type of device (in vitro diagnostic assay). For a diagnostic assay, "ground truth" is typically established by reference methods or clinical diagnosis, not by experts reviewing images or other subjective data. The performance is assessed against known values (for precision, linearity) or by comparison with an accepted predicate device (for correlation).

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of expert review or adjudication for the test set. Performance is based on quantitative measurements.

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. This device is an in vitro diagnostic assay for measuring total bile acids, not an imaging-based AI device that would involve human readers or image interpretation.

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

This device is an in vitro diagnostic assay, which inherently operates "standalone" in the sense that it quantifies a specific analyte (total bile acids) without human intervention in the measurement process itself, beyond sample preparation and loading. The results are generated by the assay's chemical/enzymatic reaction and detection system. This isn't an AI algorithm in the typical sense that would have a "human-in-the-loop" component for interpretation of its output.

7. The Type of Ground Truth Used

The ground truth used for this device's evaluation includes:

• Known concentrations: For evaluating precision and linearity (though linearity data is not detailed here, it's a standard part of IVD validation).
• Comparison to a legally marketed predicate device: "Trinity's method" was used as the comparator for assessing correlation, implying its results are considered a valid reference for comparison.
• Spiked samples: For interference studies, known interfering substances were added to "pooled human sera" in controlled concentrations.

8. The Sample Size for the Training Set

This information is not applicable. This device is a traditional enzymatic assay, not a machine learning or AI model that requires a "training set" in the context of algorithm development. Its "training" is inherent in the chemical and enzymatic reactions designed by the manufacturer.

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

This information is not applicable for the same reasons as point 8.

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