# K062503: Catachem, Inc., Bile Acids Reagents and/or Bile Acids Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Catachem, Inc.
- Decided: Jan 19, 2007 after 147 days
- Product code: KWW (Radioimmunoassay, Cholyglycine, Bile Acids)
- Device class: 2
- Regulation: 21 CFR 862.1177
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Catachemn, 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.

Source page: https://510kreport.com/device/K062503
Methodology: https://510kreport.com/methodology