Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart H — Hematology Kits and Packages](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages) → [21 CFR 864.7660](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7660) → JCJ — Alkaline Phosphatase

# JCJ · Alkaline Phosphatase

_Hematology · 21 CFR 864.7660 · Class 1_

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

## Overview

- **Product Code:** JCJ
- **Device Name:** Alkaline Phosphatase
- **Regulation:** [21 CFR 864.7660](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/864.7660)
- **Device Class:** 1
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

A leukocyte alkaline phosphatase test is a device used to identify the enzyme leukocyte alkaline phosphatase in neutrophilic granulocytes (granular leukocytes stainable by neutral dyes). The cytochemical identification of alkaline phosphatase depends on the formation of blue granules in cells containing alkaline phosphatase. The results of this test are used to differentiate chronic granulocytic leukemia (a malignant disease characterized by excessive overgrowth of granulocytes in the bone marrow) and reactions that resemble true leukemia, such as those occuring in severe infections and polycythemia (increased total red cell mass).

## Classification Rationale

Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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

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