Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7100](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7100) → JBE — Cell Enzymes (Erythrocytic And Leukocytic)

# JBE · Cell Enzymes (Erythrocytic And Leukocytic)

_Hematology · 21 CFR 864.7100 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBE

## Overview

- **Product Code:** JBE
- **Device Name:** Cell Enzymes (Erythrocytic And Leukocytic)
- **Regulation:** [21 CFR 864.7100](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7100)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)
- **3rd-party reviewable:** yes

## Identification

Red blood cell enzyme assay is a device used to measure the activity in red blood cells of clinically important enzymatic reactions and their products, such as pyruvate kinase or 2,3-diphosphoglycerate. A red blood cell enzyme assay is used to determine the enzyme defects responsible for a patient's hereditary hemolytic anemia.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K822733](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBE/K822733.md) | SIGMA REAGENT SYSTEM NO. 885 | Sigma Chemical Co. | Dec 3, 1982 | SESE |

## Top Applicants

- Sigma Chemical Co. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBE](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/JBE)

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