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 862.1535](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1535) → JMY — Citrulline, Arsenate, Nessler (Colorimetry), Ornithine Carbamyl Transferase

# JMY · Citrulline, Arsenate, Nessler (Colorimetry), Ornithine Carbamyl Transferase

_Clinical Chemistry · 21 CFR 862.1535 · Class 1_

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

## Overview

- **Product Code:** JMY
- **Device Name:** Citrulline, Arsenate, Nessler (Colorimetry), Ornithine Carbamyl Transferase
- **Regulation:** [21 CFR 862.1535](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1535)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

An ornithine carbamyl transferase test system is a device intended to measure the activity of the enzyme ornithine carbamyl transferase (OCT) in serum. Ornithine carbamyl transferase measurements are used in the diagnosis and treatment of liver diseases, such as infectious hepatitis, acute cholecystitis (inflammation of the gall bladder), cirrhosis, and liver metastases.

## 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/JMY](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JMY)

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