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510(k) K093908

CCPOINT by Euro-Diagnostica AB — Product Code NHX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2010
Date Received
December 22, 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.

Other clearances by Euro-Diagnostica AB

  • K091657 — IMMUNOSCAN CCPLUS (November 19, 2009)
  • K062045 — EDIA ANTI-CCP (December 4, 2006)
  • K971689 — IMMUNOSCAN ANTI-MYELOPEROXIDASE ANTIBODIES (MPO-ANCA) QUANTITATIVE KIT (October 29, 1997)
  • K971464 — IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT (October 29, 1997)
  • K971690 — IMMUNOSCAN PR3-ANCA (October 29, 1997)

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)
  • K093954 — BIOPLEX 2200 ANTI-CCP KIT ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (August 24, 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)