(163 days)
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.
| Performance Characteristic | Acceptance Criteria (Implicit/Inferred) | Reported Device Performance |
|---|---|---|
| Precision | Good precision (low CV%) for both intra-assay and inter-assay measurements, across different concentration levels. | Intra-Assay: 8 μM = 3.9% CV%, 23 μM = 1.3% CV% |
| Inter-Assay: 8 μM = 2.9% CV%, 23 μM = 2.6% CV% | ||
| Correlation with Predicate | "Good correlation" with the legally marketed predicate device (Trinity's method). | Correlation coefficient = 0.99 |
| Interference | "Less than 1% interference" at specified concentrations for common interfering substances. | Triglyceride: 750 mg/dl = |
§ 862.1177 Cholylglycine test system.
(a)
Identification. A cholylglycine test system is a device intended to measure the bile acid cholylglycine in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders, such as cirrhosis or obstructive liver disease.(b)
Classification. Class II.