Abbott Architect Folate
by Abbott Laboratories 510(k)
Active
510(k) K984301
Overview
The Abbott Architect Folate is a Chemiluminescent Microparticle Folate Binding Protein assay for the quantitative determination of folate in human serum, plasma, and red blood cells on the Abbott Architect i System. Measurements obtained by this device aid in the diagnosis and treatment of megaloblastic anemia.
The device is supplied as a Class II medical device with product code CGN, classified as Acid, Folic, Radioimmunoassay. It received FDA 510(k) clearance with number K984301 on February 5, 1999, after being submitted by Abbott Laboratories. The device is intended for use in clinical chemistry settings for quantitative folate measurement.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK984301 | Date5 Feb 1999 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CGN
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1295
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the Abbott Architect Folate assay used for?
The Abbott Architect Folate is a chemiluminescent microparticle assay used for the quantitative determination of folate in human serum, plasma, and red blood cells. It aids in the diagnosis and treatment of megaloblastic anemia.
How is the Abbott Architect Folate assay supplied?
The device is supplied as a Class II medical device with product code CGN, classified as Acid, Folic, Radioimmunoassay. It is intended for use in clinical chemistry settings for quantitative folate measurement.
What is the regulatory status of the Abbott Architect Folate assay?
The Abbott Architect Folate received FDA 510(k) clearance with number K984301 on February 5, 1999, after being submitted by Abbott Laboratories. It was determined to be substantially equivalent to predicate devices.
What samples can be used with the Abbott Architect Folate assay?
The Abbott Architect Folate assay can be used with human serum, plasma, and red blood samples for quantitative folate measurement, making it suitable for various clinical testing scenarios.