Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1177](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1177) → KWW — Radioimmunoassay, Cholyglycine, Bile Acids

# KWW · Radioimmunoassay, Cholyglycine, Bile Acids

_Clinical Chemistry · 21 CFR 862.1177 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW

## Overview

- **Product Code:** KWW
- **Device Name:** Radioimmunoassay, Cholyglycine, Bile Acids
- **Regulation:** [21 CFR 862.1177](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1177)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II.

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K062503](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW/K062503.md) | CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT | Catachem, Inc. | Jan 19, 2007 | SESE |
| [K051714](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW/K051714.md) | TOTAL BILE ACIDS ASSAY, MODEL DZ042A | Diazyme Laboratories | Dec 7, 2005 | SESE |
| [K970120](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW/K970120.md) | BILE ACIDS REAGENT SET | Teco Diagnostics | Mar 24, 1997 | SESE |
| [K872296](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW/K872296.md) | BILE ACIDS REAGENT | Sigma Diagnostics, Inc. | Aug 26, 1987 | SESE |
| [K803296](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW/K803296.md) | ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT | Immunotech Corp. | Jan 16, 1981 | SESE |
| [K781337](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW/K781337.md) | CONJUGATED BILE ACIDS RIA KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Aug 11, 1978 | SESE |

## Top Applicants

- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Catachem, Inc. — 1 clearance
- Diazyme Laboratories — 1 clearance
- Immunotech Corp. — 1 clearance
- Sigma Diagnostics, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/KWW)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com