Abbott Vision Glycated Hb
by Abbott Laboratories 510(k)
Active
510(k) K904027
Overview
The Abbott Vision Glycated Hb is an assay device designed to measure glycosylated hemoglobin (HbA1c) levels in blood samples. HbA1c testing is a standard diagnostic tool for monitoring long-term blood glucose control in patients with diabetes, providing critical insights into glycemic management and treatment efficacy.
This device is intended for use in clinical laboratories and healthcare settings, supplied as a reagent kit for in-vitro diagnostic testing. It is classified as a Class II medical device under FDA regulations (21 CFR 864.7470) and has received FDA 510(k) clearance (K904027) as substantially equivalent to a predicate device. The assay is single-use, requiring no special storage conditions beyond refrigeration, and is not intended for MRI environments.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK904027 | Date7 Feb 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Abbott Vision(Tm) Glycated Hb
- 510(k) Number
- FDA Product Code
- LCP
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.7470
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the Abbott Vision™ Glycated Hb used for in clinical settings?
The Abbott Vision™ Glycated Hb is an assay device designed specifically to measure glycosylated hemoglobin (HbA1c) levels in blood samples. HbA1c testing is a key diagnostic tool for monitoring long-term blood glucose control in patients with diabetes, helping clinicians assess glycemic management and treatment effectiveness over weeks and months.
Is the Abbott Vision™ Glycated Hb single-use or reusable, and what storage requirements apply?
The Abbott Vision™ Glycated Hb is a single-use assay device, meaning each kit is intended for one test only. Storage is straightforward—no special conditions are required beyond refrigeration, ensuring stability and reliability for clinical use.
Where can this device be used, and what type of healthcare facility is it intended for?
This device is intended exclusively for use in clinical laboratories and healthcare settings where in-vitro diagnostic testing is performed. It is not designed for home use or point-of-care testing outside regulated environments.
Does the Abbott Vision™ Glycated Hb have any specific environmental restrictions, such as MRI compatibility?
The device is explicitly not intended for use in MRI environments, though this restriction is likely due to the assay’s reagent kit components rather than the device itself. Standard clinical lab settings without MRI interference are the intended use.
What regulatory pathway was followed for FDA clearance of the Abbott Vision™ Glycated Hb?
The Abbott Vision™ Glycated Hb received FDA 510(k) clearance under a traditional review process, demonstrating substantial equivalence to a predicate device. The clearance was granted on February 7, 1991, and the device is classified as a Class II medical device under FDA regulations (21 CFR 864.7470).