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 862.1250](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1250) → JLE — Radioimmunoassay, Desoxycorticosterone

# JLE · Radioimmunoassay, Desoxycorticosterone

_Clinical Chemistry · 21 CFR 862.1250 · Class 1_

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

## Overview

- **Product Code:** JLE
- **Device Name:** Radioimmunoassay, Desoxycorticosterone
- **Regulation:** [21 CFR 862.1250](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1250)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A desoxycorticosterone test system is a device intended to measure desoxycorticosterone (DOC) in plasma and urine. DOC measurements are used in the diagnosis and treatment of patients with hypermineralocorticoidism (excess retention of sodium and loss of potassium) and other disorders of the adrenal gland.

## 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._

---

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

**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