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510(k) K243979

Aptiva APS IgA Reagent by Inova Diagnostics, Inc. — Product Code MSV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2026
Date Received
December 23, 2024
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 Inova Diagnostics, Inc.

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  • 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)
  • K163538 — QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM (September 6, 2017)

Other clearances for product code MSV

  • 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)
  • K040450 — VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996 (May 11, 2004)