510(k) K093954

BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM by Bio-Rad Laboratories — Product Code NHX

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 24, 2010
Date Received: December 23, 2009
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
Device Class: Class II
Regulation Number: 866.5775
Review Panel: IM
Submission Type

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.

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Other clearances for product code NHX

K153551 — ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Qual (August 4, 2016)
K143754 — QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 (September 21, 2015)
K121576 — IMMULITE 2000 ANTI-CCP IGG ASSAY (April 4, 2013)
K112810 — MULTI-ANALYTE DETECTION SYSTEMS (October 26, 2011)
K110296 — AXIS-SHIELD ANTI-CCP (August 18, 2011)
K093908 — CCPOINT (December 1, 2010)
K090753 — THERATEST EL-ANTI-CCP/2 (March 5, 2010)
K091657 — IMMUNOSCAN CCPLUS (November 19, 2009)
K083868 — ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P (September 25, 2009)
K081338 — ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP (September 11, 2008)