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510(k) Data Aggregation
(147 days)
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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(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 = |
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(69 days)
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