Cleared Traditional

K091657 - IMMUNOSCAN CCPLUS

K091657 is an FDA 510(k) clearance for IMMUNOSCAN CCPLUS, 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 163-day FDA review.

K091657 · Euro-Diagnostica AB · Immunology device
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Nov 2009
Decision
163d
Days
Class 2
Risk

K091657 is an FDA 510(k) clearance for the IMMUNOSCAN CCPLUS. Classified as Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (product code NHX), Class II - Special Controls.

Submitted by Euro-Diagnostica AB (Malmo, SE). The FDA issued a Cleared decision on November 19, 2009 after a review of 163 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 Euro-Diagnostica AB devices

FDA 510(k) Submission Details - K091657

510(k) Number K091657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2009
Decision Date November 19, 2009
Days to Decision 163 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
58d slower than avg
Panel avg: 105d · This submission: 163d
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 K091657.
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
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