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 862.1430](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1430) → CDE — Chromatographic Separation/Zimmerman, 17-Ketosteroids

# CDE · Chromatographic Separation/Zimmerman, 17-Ketosteroids

_Clinical Chemistry · 21 CFR 862.1430 · Class 1_

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

## Overview

- **Product Code:** CDE
- **Device Name:** Chromatographic Separation/Zimmerman, 17-Ketosteroids
- **Regulation:** [21 CFR 862.1430](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1430)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A 17-ketosteroids test system is a device intended to measure 17-ketosteroids in urine. Measurements of 17-ketosteroids are used in the diagnosis and treatment of disorders of the adrenal cortex and gonads and of other endocrine disorders, including hypertension, diabetes, and hypothyroidism.

## 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 (0 of 0)

_No cleared devices on record._

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

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