CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT

• K Number: K062503
• Device Name: CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT
• Manufacturer: CATACHEM, INC.
• Date Cleared: 2007-01-19 ( 147 days)
• Product Code: KWW , JIS , JJX
• Regulation Number: 862.1177
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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.

Device Description

Not Found

AI/ML Overview

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.

Regulation Number and Section

§ 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.