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 862.1820](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1820) → JOC — Colorimetric, Xylose

# JOC · Colorimetric, Xylose

_Clinical Chemistry · 21 CFR 862.1820 · Class 1_

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

## Overview

- **Product Code:** JOC
- **Device Name:** Colorimetric, Xylose
- **Regulation:** [21 CFR 862.1820](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1820)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A xylose test system is a device intended to measure xylose (a sugar) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of gastrointestinal malabsorption syndrome (a group of disorders in which there is subnormal absorption of dietary constituents and thus excessive loss from the body of the nonabsorbed substances).

## 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 |
| --- | --- | --- | --- | --- |
| [K991156](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JOC/K991156.md) | GREAT SMOKIES INTESTINAL PERMABILITY TEST SYSTEM | Great Smokies Diagnostic Laboratory | May 28, 1999 | SESE |

## Top Applicants

- Great Smokies Diagnostic Laboratory — 1 clearance

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

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