GHD · Test, Leukocyte Alkaline Phosphatase
Hematology · 21 CFR 864.7660 · Class 1
Overview
| Product Code | GHD |
|---|---|
| Device Name | Test, Leukocyte Alkaline Phosphatase |
| Regulation | 21 CFR 864.7660 |
| Device Class | Class 1 |
| Review Panel | Hematology |
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 (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K904022 | NITRO BLUE TETRAZOLIUM REDUCTION | Sigma Chemical Co. | Dec 18, 1990 | SESE |
| K903995 | NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT | Sigma Chemical Co. | Dec 13, 1990 | SESE |
| K896092 | ALKALINE PHOSPHATASE, LEUKOCYTE, KIT | Sigma Chemical Co. | Nov 9, 1989 | SESE |
| K811189 | CHEMSTRIP L | Biodynamics Corp. | Jul 27, 1981 | SESE |
Top Applicants
- Sigma Chemical Co. — 3 clearances
- Biodynamics Corp. — 1 clearance
