Cleared Traditional

BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

K093954 · Bio-Rad Laboratories · Immunology

Aug 2010

Decision

244d

Days

Class 2

Risk

About This 510(k) Submission

K093954 is an FDA 510(k) clearance for the BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, a Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (Class II — Special Controls, product code NHX), submitted by Bio-Rad Laboratories (Benicia, US). The FDA issued a Cleared decision on August 24, 2010, 244 days after receiving the submission on December 23, 2009. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number	K093954 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2009
Decision Date	August 24, 2010
Days to Decision	244 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.