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510(k) K162961

LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set by DiaSorin, Inc. — Product Code LSE

K162961 is an FDA 510(k) premarket notification submitted by DiaSorin, Inc. for the device "LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set". The FDA issued a decision of Substantially Equivalent on January 5, 2017. The device falls under product code LSE (Epstein-Barr Virus, Other), a Class I device regulated under 21 CFR 866.3235. DiaSorin, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2017
Date Received
October 24, 2016
Clearance Type
Special
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 DiaSorin, Inc.

  • K260770 — LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX (June 4, 2026)
  • DEN250032 — LIAISON® XL MUREX Anti-HDV (318260); LIAISON® XL MUREX Control Anti-HDV (318261) (December 23, 2025)
  • K231214 — LIAISON VZV IgG HT, LIAISON Control VZV IgG HT (October 27, 2023)
  • K223403 — LIAISON Anti-HAV; LIAISON XS (December 9, 2022)
  • K213858 — LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus (July 26, 2022)
  • K213936 — LIAISON MeMed BV, LIAISON MeMed BV Control Set (July 14, 2022)
  • K193650 — LIAISON Ferritin (September 14, 2021)
  • K202573 — LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus (February 18, 2021)
  • K202574 — LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus (February 18, 2021)
  • K210272 — LIAISON Anti-HAV (February 9, 2021)

Other clearances for product code LSE

  • K233606 — ADVIA Centaur EBV-VCA IgM (August 7, 2024)
  • 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