Cleared Traditional

ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35

K083868 · Axis-Shield Diagnostics, Ltd. · Immunology

Sep 2009

Decision

270d

Days

Class 2

Risk

About This 510(k) Submission

K083868 is an FDA 510(k) clearance for the ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35, a Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (Class II — Special Controls, product code NHX), submitted by Axis-Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on September 25, 2009, 270 days after receiving the submission on December 29, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number	K083868 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 29, 2008
Decision Date	September 25, 2009
Days to Decision	270 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement

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.