Hemoglobin Electrophoresis Meth on the-
by Olympus Corp. 510(k)
Active
510(k) K831055
Overview
The Hemoglobin Electrophoresis Method on the- is a Test, Euglobulin Lysis device classified under FDA regulation 864.7275, designed for the separation and analysis of hemoglobin fractions in blood samples. This method employs electrophoresis to differentiate hemoglobin variants, aiding in the diagnosis of hemoglobinopathies such as sickle cell disease, thalassemia, and other hematologic disorders.
This device is intended for use in clinical hematology laboratories, where trained personnel perform the test on whole blood or erythrocyte lysates. Supplied as a single-use method, it requires compatibility with standard electrophoresis equipment and reagents. The method adheres to FDA clearance (K831055) under a Traditional 510(k) review, with no third-party review involved. Storage and handling follow standard laboratory protocols for diagnostic reagents.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK831055 | Date8 Jun 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JBO
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7275
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Olympus Corp.
Questions
What clinical conditions is this hemoglobin electrophoresis method primarily used to diagnose or monitor?
This method is designed to separate and analyze hemoglobin fractions in blood samples, helping diagnose or monitor hemoglobinopathies such as sickle cell disease and thalassemia. It differentiates hemoglobin variants through electrophoresis, which is critical for identifying these conditions in clinical hematology laboratories.
Is this device single-use or reusable, and how should it be handled in a lab setting?
The device is supplied as a single-use method, meaning each test kit is intended for one use only. Since it requires compatibility with standard electrophoresis equipment and reagents, labs should follow standard laboratory protocols for storage and handling to ensure proper sterility and performance.
What type of blood sample can be used with this method, and where is it intended for use?
This method is intended for use with whole blood or erythrocyte lysates, making it versatile for standard hematology lab workflows. It is specifically designed for clinical hematology laboratories where trained personnel perform diagnostic testing.
How is this device regulated, and what does the clearance status mean for users?
The device holds an FDA clearance (K831055) under a Traditional 510(k) review, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance was granted by the Hematology (HE) advisory committee in 1983, ensuring it meets regulatory standards for use in clinical settings.