Cleared Traditional

EDIA ANTI-CCP

K062045 · Euro-Diagnostica AB · Immunology

Dec 2006

Decision

138d

Days

Class 2

Risk

About This 510(k) Submission

K062045 is an FDA 510(k) clearance for the EDIA ANTI-CCP, a Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (Class II — Special Controls, product code NHX), submitted by Euro-Diagnostica AB (Malmo, SE). The FDA issued a Cleared decision on December 4, 2006, 138 days after receiving the submission on July 19, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number	K062045 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 2006
Decision Date	December 04, 2006
Days to Decision	138 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.