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 862.1365](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1365) → JLO — Enzymatic (Glutathione Reductase), Glutathione

# JLO · Enzymatic (Glutathione Reductase), Glutathione

_Clinical Chemistry · 21 CFR 862.1365 · Class 1_

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

## Overview

- **Product Code:** JLO
- **Device Name:** Enzymatic (Glutathione Reductase), Glutathione
- **Regulation:** [21 CFR 862.1365](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1365)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A glutathione test system is a device intended to measure glutathione (the tripeptide of glycine, cysteine, and glutamic acid) in erythrocytes (red blood cells). Glutathione measurements are used in the diagnosis and treatment of certain drug-induced hemolytic (erythrocyte destroying) anemias due to an inherited enzyme deficiency.

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

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