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510(k) K233606

ADVIA Centaur EBV-VCA IgM by Biokit, S.A. — Product Code LSE

K233606 is an FDA 510(k) premarket notification submitted by Biokit, S.A. for the device "ADVIA Centaur EBV-VCA IgM". The FDA issued a decision of Substantially Equivalent on August 7, 2024. The device falls under product code LSE (Epstein-Barr Virus, Other), a Class I device regulated under 21 CFR 866.3235. Biokit, S.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2024
Date Received
November 9, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Epstein-Barr Virus, Other
Device Class
Class I
Regulation Number
866.3235
Review Panel
MI
Submission Type

Other clearances by Biokit, S.A.

  • K243575 — ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Control (February 12, 2025)
  • K233605 — ADVIA Centaur EBV-EBNA IgG (August 7, 2024)
  • K213987 — ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Control (September 20, 2023)
  • K214068 — Quantia IgE (February 21, 2023)
  • K181334 — ADVIA Centaur Herpes-2 IgG (August 23, 2018)
  • K181333 — ADVIA Centaur Herpes-1 IgG (August 23, 2018)
  • K152185 — ARCHITECT SHBG (February 11, 2016)
  • K132400 — LP(A) CALIBRATORS, AND LP(A) CONTROLS (December 19, 2013)
  • K123947 — ARCHITECT IVANCOMYCIN (August 29, 2013)
  • K110619 — ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D (November 23, 2011)

Other clearances for product code LSE

  • K162961 — LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and L (January 5, 2017)
  • K162959 — LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set (January 4, 2017)
  • K091260 — SERAQUEST EBV EA-D IGG TEST (June 8, 2009)
  • K073382 — PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G (July 28, 2008)
  • K062211 — BIOPLEX 2200 EBV IGG PANEL FOR BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (December 8, 2006)
  • K062213 — BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM (December 8, 2006)
  • K060204 — LIAISON EA IGG (October 18, 2006)
  • K033915 — MODIFICATION TO SERAQUEST EB VCA IGG (January 16, 2004)
  • K030863 — EBV VCA-P18 IGG ELISA (June 27, 2003)
  • K021793 — EBV EA-D IGG ELISA KIT, MODEL EBG-100 (September 27, 2002)

FDA data resources