Cleared Traditional

K063347 - AXSYM ANTI-CCP REAGENT

K063347 is the FDA 510(k) clearance for AXSYM ANTI-CCP REAGENT by Axis-Shield Diagnostics, Ltd.. It is a Class 2 Immunology device (product code NHX) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K063347 · Axis-Shield Diagnostics, Ltd. · Immunology device
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Mar 2007
Decision
134d
Days
Class 2
Risk

K063347 is an FDA 510(k) clearance for the AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20,.... Classified as Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (product code NHX), Class II - Special Controls.

Submitted by Axis-Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on March 20, 2007 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5775 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Axis-Shield Diagnostics, Ltd. devices

Submission Details

510(k) Number K063347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2006
Decision Date March 20, 2007
Days to Decision 134 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 104d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHX Antibodies, Anti-cyclic Citrullinated Peptide (ccp)
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - NHX Antibodies, Anti-cyclic Citrullinated Peptide (ccp)

All 8
Devices cleared under the same product code (NHX) and FDA review panel - the closest regulatory comparables to K063347.
BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K093954 · Bio-Rad Laboratories · Aug 2010
ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP
K081338 · Roche Diagnostics · Sep 2008
QUANTA LITE CCP3.1 IGG/IGA ELISA
K072944 · Inova Diagnostics, Inc. · Mar 2008
QUANTA LITE CCP3 IGG ELISA
K052264 · Inova Diagnostics, Inc. · Nov 2005
QUANTA LITE CCP ELISA
K020414 · Inova Diagnostics, Inc. · Apr 2002