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 862.1255](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1255) → JLY — Phosphoglycerate Mutase (Colorimetric), 2,3-Diphosphoglyceric Acid

# JLY · Phosphoglycerate Mutase (Colorimetric), 2,3-Diphosphoglyceric Acid

_Clinical Chemistry · 21 CFR 862.1255 · Class 1_

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

## Overview

- **Product Code:** JLY
- **Device Name:** Phosphoglycerate Mutase (Colorimetric), 2,3-Diphosphoglyceric Acid
- **Regulation:** [21 CFR 862.1255](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1255)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## Identification

A 2,3-diphosphoglyceric acid test system is a device intended to measure 2,3-diphosphoglyceric acid (2,3-DPG) in erythrocytes (red blood cells). Measurements of 2,3-diphosphoglyceric acid are used in the diagnosis and treatment of blood disorders that affect the delivery of oxygen by erythrocytes to tissues and in monitoring the quality of stored blood.

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

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