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510(k) K061165

ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01 by Sweden Diagnostics (Us), Inc. — Product Code NHX

K061165 is an FDA 510(k) premarket notification submitted by Sweden Diagnostics (Us), Inc. for the device "ELIA CCP, MODEL 14-5515-01; ELIA CCP CONTROL, MODEL 83-1009-01". The FDA issued a decision of Substantially Equivalent on August 3, 2006. The device falls under product code NHX (Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)), a Class II device regulated under 21 CFR 866.5775.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 2006
Date Received
April 26, 2006
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 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)
  • 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)

FDA data resources