Cleared Traditional

THERATEST EL-ANTI-CCP/2

K090753 · Theratest Laboratories, Inc. · Immunology

Mar 2010

Decision

350d

Days

Class 2

Risk

About This 510(k) Submission

K090753 is an FDA 510(k) clearance for the THERATEST EL-ANTI-CCP/2, a Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (Class II — Special Controls, product code NHX), submitted by Theratest Laboratories, Inc. (Lombard, US). The FDA issued a Cleared decision on March 5, 2010, 350 days after receiving the submission on March 20, 2009. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number	K090753 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 20, 2009
Decision Date	March 05, 2010
Days to Decision	350 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.