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 862.1385](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1385) → CDG — Chromatography Separation/Zimmerman 17-Ketogenic Steroids

# CDG · Chromatography Separation/Zimmerman 17-Ketogenic Steroids

_Clinical Chemistry · 21 CFR 862.1385 · Class 1_

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

## Overview

- **Product Code:** CDG
- **Device Name:** Chromatography Separation/Zimmerman 17-Ketogenic Steroids
- **Regulation:** [21 CFR 862.1385](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1385)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A 17-hydroxycorticosteroids (17-ketogenic steroids) test system is a device intended to measure corticosteroids that possess a dihydroxyacetone moiety on the steroid nucleus in urine. Corticosteroids with this chemical configuration include cortisol, cortisone 11-desoxycortisol, desoxycorticosterone, and their tetrahydroderivatives. This group of hormones is synthesized by the adrenal gland. Measurements of 17-hydroxycorticosteroids (17-ketogenic steroids) are used in the diagnosis and treatment of various diseases of the adrenal or pituitary glands and gonadal disorders.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K772337](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDG/K772337.md) | URINARY 17-KETOSTERIOD/17 | Eppendorf-Brinkmann, Inc. | Jan 12, 1978 | SESE |

## Top Applicants

- Eppendorf-Brinkmann, Inc. — 1 clearance

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

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