Cleared Traditional

AXIS-SHIELD ANTI-CCP

K110296 · Axis-Shield Diagnostics, Ltd. · Immunology

Aug 2011

Decision

198d

Days

Class 2

Risk

About This 510(k) Submission

K110296 is an FDA 510(k) clearance for the AXIS-SHIELD ANTI-CCP, a Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (Class II — Special Controls, product code NHX), submitted by Axis-Shield Diagnostics, Ltd. (Dundee, Scotland, GB). The FDA issued a Cleared decision on August 18, 2011, 198 days after receiving the submission on February 1, 2011. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number	K110296 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2011
Decision Date	August 18, 2011
Days to Decision	198 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.