Cleared Traditional

K093908 - CCPOINT

K093908 is an FDA 510(k) clearance for CCPOINT, manufactured by Euro-Diagnostica AB. The device is a Class 2 Immunology device with product code NHX cleared through the Traditional 510(k) pathway after a 344-day FDA review.

K093908 · Euro-Diagnostica AB · Immunology device
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Dec 2010
Decision
344d
Days
Class 2
Risk

K093908 is an FDA 510(k) clearance for the CCPOINT. Classified as Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (product code NHX), Class II - Special Controls.

Submitted by Euro-Diagnostica AB (West Cadwell, US). The FDA issued a Cleared decision on December 1, 2010 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Euro-Diagnostica AB devices

FDA 510(k) Submission Details - K093908

510(k) Number K093908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2009
Decision Date December 01, 2010
Days to Decision 344 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
239d slower than avg
Panel avg: 105d · This submission: 344d
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 K093908.
IMMULITE 2000 ANTI-CCP IGG ASSAY
K121576 · Siemens Healthcare Diagnostics, Inc. · Apr 2013
MULTI-ANALYTE DETECTION SYSTEMS
K112810 · Bio-Rad Laboratories · Oct 2011
AXIS-SHIELD ANTI-CCP
K110296 · Axis-Shield Diagnostics, Ltd. · Aug 2011
BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K093954 · Bio-Rad Laboratories · Aug 2010
THERATEST EL-ANTI-CCP/2
K090753 · Theratest Laboratories, Inc. · Mar 2010
ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35
K083868 · Axis-Shield Diagnostics, Ltd. · Sep 2009