DeviceClearance

Product code NHX— Immunology

ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.

Classification name
Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Device class
Class 2
Regulation
21 CFR 866.5775
Advisory panel
Immunology
Total cleared
21
First cleared
Most recent

FDA classification definition

“The device is used for the detection of anti-cyclic citrullinated peptide (CCP) antibodies in human serum or plasma as an aid in the diagnosis of rheumatoid arthritis.”

— U.S. Food and Drug Administration, device classification record for product code NHX under 21 CFR 866.5775, via openFDA

Market context for product code NHX

FDA has cleared 21 devices under product code NHX between 2002 and 2016, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NHX

Recent clearances under product code NHX

Data sourced from openFDA. This site is unofficial and independent of the FDA.