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 862.1080](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1080) → CIY — Radioimmunoassay, Androsterone

# CIY · Radioimmunoassay, Androsterone

_Clinical Chemistry · 21 CFR 862.1080 · Class 1_

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

## Overview

- **Product Code:** CIY
- **Device Name:** Radioimmunoassay, Androsterone
- **Regulation:** [21 CFR 862.1080](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1080)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

An androsterone test system is a device intended to measure the hormone adrosterone in serum, plasma, and urine. Androsterone measurements are used in the diagnosis and treatment of gonadal and adrenal diseases.

## 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 |
| --- | --- | --- | --- | --- |
| [K771793](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIY/K771793.md) | DHEA TEST SET | Wien Laboratories, Inc. | Nov 2, 1977 | SESE |

## Top Applicants

- Wien Laboratories, Inc. — 1 clearance

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

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