Home / 510(k) Clearances / K021516

510(k) K021516

DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200 by Axis-Shield Diagnostics, Ltd. — Product Code NHX

K021516 is an FDA 510(k) premarket notification submitted by Axis-Shield Diagnostics, Ltd. for the device "DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200". The FDA issued a decision of Substantially Equivalent on July 23, 2002. The device falls under product code NHX (Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)), a Class II device regulated under 21 CFR 866.5775. Axis-Shield Diagnostics, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2002
Date Received
May 10, 2002
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 Axis-Shield Diagnostics, Ltd.

  • K253539 — Alere NT-proBNP for Alinity i (February 18, 2026)
  • K241176 — Alere NT-proBNP for Alinity i Reagent Kit (January 16, 2025)
  • K233541 — ARCHITECT Active-B12 (Holotranscobalamin) (July 31, 2024)
  • K172133 — ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay (October 27, 2017)
  • K121946 — AXIS-SHIELD ACVTIVE-B12 (March 22, 2013)
  • K121842 — ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C (December 12, 2012)
  • K112790 — AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON (May 7, 2012)
  • K112443 — ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) (December 19, 2011)
  • K110296 — AXIS-SHIELD ANTI-CCP (August 18, 2011)
  • K083868 — ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P (September 25, 2009)

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