Cleared Special

K112810 - MULTI-ANALYTE DETECTION SYSTEMS

K112810 is the FDA 510(k) clearance for MULTI-ANALYTE DETECTION SYSTEMS by Bio-Rad Laboratories. It is a Class 2 Immunology device (product code NHX) cleared through the Special 510(k) pathway after a 29-day FDA review.

K112810 · Bio-Rad Laboratories · Immunology device
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Oct 2011
Decision
29d
Days
Class 2
Risk

K112810 is an FDA 510(k) clearance for the MULTI-ANALYTE DETECTION SYSTEMS. 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 October 26, 2011 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5775 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bio-Rad Laboratories devices

Submission Details

510(k) Number K112810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2011
Decision Date October 26, 2011
Days to Decision 29 days
Submission Type Special
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
75d faster than avg
Panel avg: 104d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 7
Devices cleared under the same product code (NHX) and FDA review panel - the closest regulatory comparables to K112810.
QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3
K143754 · Inova Diagnostics, Inc. · Sep 2015
IMMULITE 2000 ANTI-CCP IGG ASSAY
K121576 · Siemens Healthcare Diagnostics, Inc. · Apr 2013
BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM
K093954 · Bio-Rad Laboratories · Aug 2010
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
QUANTA LITE CCP3 IGG ELISA
K052264 · Inova Diagnostics, Inc. · Nov 2005