Cleared Traditional

QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3

K143754 · Inova Diagnostics, Inc. · Immunology

Sep 2015

Decision

264d

Days

Class 2

Risk

About This 510(k) Submission

K143754 is an FDA 510(k) clearance for the QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3, a Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (Class II — Special Controls, product code NHX), submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on September 21, 2015, 264 days after receiving the submission on December 31, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number	K143754 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 31, 2014
Decision Date	September 21, 2015
Days to Decision	264 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.