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510(k) K052264

QUANTA LITE CCP3 IGG ELISA by Inova Diagnostics, Inc. — Product Code NHX

K052264 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA LITE CCP3 IGG ELISA". The FDA issued a decision of Substantially Equivalent on November 23, 2005. The device falls under product code NHX (Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)), a Class II device regulated under 21 CFR 866.5775. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2005
Date Received
August 19, 2005
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 Inova Diagnostics, Inc.

  • K243979 — Aptiva APS IgA Reagent (February 6, 2026)
  • K223093 — Aptiva APS IgG Reagent; Aptiva APS IgM Reagent (December 17, 2024)
  • K213403 — Aptiva CTD Essential Reagent (September 29, 2023)
  • K200230 — Aptiva Celiac Disease IgG Reagent (August 26, 2021)
  • K193604 — Aptiva Celiac Disease IgA Reagent (June 16, 2021)
  • K192916 — NOVA Lite DAPI dsDNA Crithidia luciliae Kit (December 11, 2020)
  • K190088 — QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents (April 17, 2019)
  • K180971 — QUANTA Flash Calprotectin and Fecal Extraction Device (October 16, 2018)
  • K180975 — QUANTA Flash HMGCR Reagents (June 25, 2018)
  • K170993 — QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANT (December 22, 2017)

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