Cleared Traditional

K093908 - CCPOINT
(FDA 510(k) Clearance)

K093908 · Euro-Diagnostica AB · Immunology

Dec 2010

Decision

344d

Days

Class 2

Risk

K093908 is an FDA 510(k) clearance for the CCPOINT, a Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (Class II — Special Controls, product code NHX), submitted by Euro-Diagnostica AB (West Cadwell, US). The FDA issued a Cleared decision on December 1, 2010, 344 days after receiving the submission on December 22, 2009. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number	K093908 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 2009
Decision Date	December 01, 2010
Days to Decision	344 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.