Vision Hemoglobin
by Abbott Laboratories 510(k)
Active
510(k) K862202
Overview
The Vision Hemoglobin is a Whole Blood Hemoglobin Determination device, classified under product code KHG. It is designed to measure hemoglobin levels in whole blood samples, providing quantitative results for clinical assessment in hematology. This device supports diagnostic evaluation of anemia, polycythemia, and other hemoglobinopathies by delivering precise hemoglobin concentration readings.
This device is intended for use in clinical laboratories and healthcare settings where hematological analysis is performed. Supplied as a single-use or reusable system (as per regulatory classification), it adheres to Class II – Special Controls under FDA regulations (864.7500). The device requires proper calibration and maintenance, with storage conditions specified in manufacturer guidelines. Its FDA 510(k) clearance (K862202) was granted in 1986 following a review by the Hematology (HE) Advisory Committee.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK862202 | Date18 Aug 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Vision(Tm) Hemoglobin
- 510(k) Number
- FDA Product Code
- KHG
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7500
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What clinical conditions does the Vision Hemoglobin device help evaluate?
The Vision Hemoglobin device is designed to measure hemoglobin levels in whole blood samples, supporting the diagnostic evaluation of anemia, polycythemia, and other hemoglobinopathies. By providing quantitative hemoglobin concentration readings, it aids clinicians in assessing patient hematological status and guiding treatment decisions.
Is the Vision Hemoglobin device single-use or reusable?
The Vision Hemoglobin device can be supplied as either single-use or reusable, depending on the specific regulatory classification and intended use. Abbott Laboratories’ guidelines outline proper calibration and maintenance requirements to ensure accurate performance, particularly for reusable systems.
What storage conditions are recommended for the Vision Hemoglobin device?
Storage conditions for the Vision Hemoglobin device are detailed in Abbott Laboratories’ manufacturer guidelines. Proper storage ensures device reliability and accuracy, particularly for reusable systems, which require adherence to calibration and maintenance protocols to maintain performance standards.
How was the FDA clearance for the Vision Hemoglobin device determined?
The Vision Hemoglobin device received FDA 510(k) clearance (K862202) in 1986 under the Hematology (HE) Advisory Committee review. The clearance was granted as substantially equivalent to a predicate device, following a traditional review process under product code KHG and Class II – Special Controls regulations.
Where can the Vision Hemoglobin device be used?
The Vision Hemoglobin device is intended for use in clinical laboratories and healthcare settings where hematological analysis is performed. Its design supports precise hemoglobin concentration measurements, making it suitable for environments requiring accurate diagnostic assessments of blood disorders.