Radioimmunoassay, Cholyglycine, Bile Acids
The Cholyglycine Bile Acids Radioimmunoassay is an in vitro diagnostic device used to measure cholyglycine (a conjugated bile acid) concentrations in serum, supporting assessment of hepatic function and enterohepatic circulation in liver and gastrointestinal conditions. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KWW, regulated under 21 CFR 862.1177, in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- KWW
- Device Class
- FDA class 2
- Regulation Number
- 862.1177
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K062503 | CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT | Jan 19, 2007 | Substantially Equivalent | Catachem, Inc. |
| K051714 | TOTAL BILE ACIDS ASSAY, MODEL DZ042A | Dec 07, 2005 | Substantially Equivalent | Diazyme Laboratories |
| K970120 | BILE ACIDS REAGENT SET | Mar 24, 1997 | Substantially Equivalent | Teco Diagnostics |
| K872296 | BILE ACIDS REAGENT | Aug 26, 1987 | Substantially Equivalent | Sigma Diagnostics, Inc. |
| K803296 | ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT | Jan 16, 1981 | Substantially Equivalent | Immunotech Corp. |
| K781337 | CONJUGATED BILE ACIDS RIA KIT | Aug 11, 1978 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.