Cleared Traditional

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

K153551 · Axis-Shield Diagnostics Limited · Immunology

Aug 2016

Decision

237d

Days

Class 2

Risk

About This 510(k) Submission

K153551 is an FDA 510(k) clearance for the ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials., a Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (Class II — Special Controls, product code NHX), submitted by Axis-Shield Diagnostics Limited (Dundee, GB). The FDA issued a Cleared decision on August 4, 2016, 237 days after receiving the submission on December 11, 2015. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number	K153551 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 11, 2015
Decision Date	August 04, 2016
Days to Decision	237 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	NHX — Antibodies, Anti-cyclic Citrullinated Peptide (ccp)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5775
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.