Cleared Traditional

K061165 - ELIA CCP, MODEL 14-5515-01

Also marketed or referenced as:
ELIA CCP CONTROL, MODEL 83-1009-01

K061165 is an FDA 510(k) clearance for ELIA CCP, manufactured by Sweden Diagnostics (Us), Inc.. The device is a Class 2 Immunology device with product code NHX cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K061165 · Sweden Diagnostics (Us), Inc. · Immunology device
Download Printable Device Report (PDF)
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Aug 2006
Decision
99d
Days
Class 2
Risk

K061165 is an FDA 510(k) clearance for the ELIA CCP, MODEL 14-5515-01. Classified as Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (product code NHX), Class II - Special Controls.

Submitted by Sweden Diagnostics (Us), Inc. (Portage, US). The FDA issued a Cleared decision on August 3, 2006 after a review of 99 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 Sweden Diagnostics (Us), Inc. devices

FDA 510(k) Submission Details - K061165

510(k) Number K061165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2006
Decision Date August 03, 2006
Days to Decision 99 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
6d faster than avg
Panel avg: 105d · This submission: 99d
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 K061165.
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
DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200
K021516 · Axis-Shield Diagnostics, Ltd. · Jul 2002