Cleared Traditional

IMMULITE 2000 ANTI-CCP IGG ASSAY

K121576 · Siemens Healthcare Diagnostics, Inc. · Immunology

Apr 2013

Decision

309d

Days

Class 2

Risk

About This 510(k) Submission

K121576 is an FDA 510(k) clearance for the IMMULITE 2000 ANTI-CCP IGG ASSAY, a Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (Class II — Special Controls, product code NHX), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on April 4, 2013, 309 days after receiving the submission on May 30, 2012. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number	K121576 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 30, 2012
Decision Date	April 04, 2013
Days to Decision	309 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.