Cleared Traditional

K153551 - ADVIA Centaur Anti-CCP IgG (aCCP) assay...

K153551 is the FDA 510(k) clearance for ADVIA Centaur Anti-CCP IgG (aCCP) assay... by Axis-Shield Diagnostics Limited. It is a Class 2 Immunology device (product code NHX) cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K153551 · Axis-Shield Diagnostics Limited · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
237d
Days
Class 2
Risk

K153551 is an FDA 510(k) clearance for the ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Q.... Classified as Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (product code NHX), Class II - Special Controls.

Submitted by Axis-Shield Diagnostics Limited (Dundee, GB). The FDA issued a Cleared decision on August 4, 2016 after a review of 237 days - an extended review cycle.

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 Limited devices

Submission Details

510(k) Number K153551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2015
Decision Date August 04, 2016
Days to Decision 237 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
133d slower than avg
Panel avg: 104d · This submission: 237d
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 K153551.
QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3
K143754 · Inova Diagnostics, Inc. · Sep 2015
IMMULITE 2000 ANTI-CCP IGG ASSAY
K121576 · Siemens Healthcare Diagnostics, Inc. · Apr 2013
MULTI-ANALYTE DETECTION SYSTEMS
K112810 · Bio-Rad Laboratories · Oct 2011
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