Cleared Traditional

K093954 - BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

K093954 is an FDA 510(k) clearance for BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLE..., manufactured by Bio-Rad Laboratories. The device is a Class 2 Immunology device with product code NHX cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K093954 · Bio-Rad Laboratories · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
244d
Days
Class 2
Risk

K093954 is an FDA 510(k) clearance for the BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM. Classified as Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (product code NHX), Class II - Special Controls.

Submitted by Bio-Rad Laboratories (Benicia, US). The FDA issued a Cleared decision on August 24, 2010 after a review of 244 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.

FDA 510(k) Submission Details - K093954

510(k) Number K093954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2009
Decision Date August 24, 2010
Days to Decision 244 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
139d slower than avg
Panel avg: 105d · This submission: 244d
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 20
Devices cleared under the same product code (NHX) and FDA review panel - the closest regulatory comparables to K093954.
MULTI-ANALYTE DETECTION SYSTEMS
K112810 · Bio-Rad Laboratories · Oct 2011
AXIS-SHIELD ANTI-CCP
K110296 · Axis-Shield Diagnostics, Ltd. · Aug 2011
CCPOINT
K093908 · Euro-Diagnostica AB · Dec 2010
THERATEST EL-ANTI-CCP/2
K090753 · Theratest Laboratories, Inc. · Mar 2010
IMMUNOSCAN CCPLUS
K091657 · Euro-Diagnostica AB · Nov 2009
ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35
K083868 · Axis-Shield Diagnostics, Ltd. · Sep 2009
K093954 · BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
Download PDF FDA Summary Bio-Rad Laboratories