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510(k) K031177

DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M by Axis-Shield Diagnostics, Ltd. — Product Code MSV

K031177 is an FDA 510(k) premarket notification submitted by Axis-Shield Diagnostics, Ltd. for the device "DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGM, MODEL FBGP 100M". The FDA issued a decision of Substantially Equivalent on June 19, 2003. The device falls under product code MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)), a Class II device regulated under 21 CFR 866.5660. Axis-Shield Diagnostics, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 2003
Date Received
April 14, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

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 MSV

  • K243979 — Aptiva APS IgA Reagent (February 6, 2026)
  • K181329 — EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay (June 25, 2018)
  • K162788 — ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody (June 19, 2017)
  • K152875 — QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar (December 21, 2015)
  • K141274 — QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTRO (February 13, 2015)
  • K112414 — ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAY (June 22, 2012)
  • K091556 — HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS (May 21, 2010)
  • K092757 — THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCR (October 9, 2009)
  • K072032 — IGG ANTI-ATHEROX TEST KIT (April 4, 2008)
  • K062217 — AESKULSKA BETA2-GLYCO-A (December 13, 2006)

FDA data resources