Cleared Traditional

K070789 - EUROIMMUN ANTI-CCP ELISA

K070789 is an FDA 510(k) clearance for EUROIMMUN ANTI-CCP ELISA, manufactured by Euroimmun Us, LLC. The device is a Class 2 Immunology device with product code NHX cleared through the Traditional 510(k) pathway after a 284-day FDA review.

K070789 · Euroimmun Us, LLC · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
284d
Days
Class 2
Risk

K070789 is an FDA 510(k) clearance for the EUROIMMUN ANTI-CCP ELISA. Classified as Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (product code NHX), Class II - Special Controls.

Submitted by Euroimmun Us, LLC (Boonton Township, US). The FDA issued a Cleared decision on December 31, 2007 after a review of 284 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 Euroimmun Us, LLC devices

FDA 510(k) Submission Details - K070789

510(k) Number K070789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2007
Decision Date December 31, 2007
Days to Decision 284 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
179d slower than avg
Panel avg: 105d · This submission: 284d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHX Device Classification - Class 2, Special Controls

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 14
Devices cleared under the same product code (NHX) and FDA review panel - the closest regulatory comparables to K070789.
ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35
K083868 · Axis-Shield Diagnostics, Ltd. · Sep 2009
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
AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10
K063347 · Axis-Shield Diagnostics, Ltd. · Mar 2007
QUANTA LITE CCP3 IGG ELISA
K052264 · Inova Diagnostics, Inc. · Nov 2005
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE (ANTI-CCP) ELISA
K023285 · Axis-Shield Diagnostics, Ltd. · Oct 2002