FDA.reportPublic FDA data

510(k) K243979

Device
Aptiva APS IgA Reagent
Applicant
Inova Diagnostics, Inc.
510(k) number
K243979
Product code
MSV
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-06
Date received
2024-12-23
Regulation
866.5660
Classification name
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Medical specialty
Immunology
Review panel
Immunology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Melissa Sanchez
Address
9900 Old Grove Rd. San Diego CA US 92131 92131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MSV#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K181329EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA ImmunoassayPhadia AB2018-06-25
K162788ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA, ImmuLisa Enhanced B2GP1 IgM Antibody ELISA, ImmuLisa Enhanced B2GP1 IgA/IgG/IgM Antibody ELISAImmco Diagnostics, Inc.2017-06-19
K152875QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 ControlsInova Diagnostics, Inc.2015-12-21
K141274QUANTA FLASH ¿2GP1-DOMAIN1; CONTROLS, HEMOSIL ACUSTAR ANTI-¿2GPI DOMAIN1; CONTROLS.Inova Diagnostics, Inc.2015-02-13
K112414ELIA B2-GLYCOPROTEIN I IGA IMMUNOASSAYPhadia US, Inc.2012-06-22
K091556HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLSInstrumentation Laboratory CO2010-05-21
K092757THERATEST EL-BETA2GPI (IGM-IGG-IGA), THERATEST EL--BETA2GPI SCRThera-Test Laboratories, Inc.2009-10-09
K072032IGG ANTI-ATHEROX TEST KITCorgenix, Inc.2008-04-04
K062217AESKULSKA BETA2-GLYCO-AAesku, Inc.2006-12-13
K040449VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796Pharmacia Deutschland GmbH2004-05-11
K040450VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996Pharmacia Deutschland GmbH2004-05-11
K040451VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896Pharmacia Deutschland GmbH2004-05-11
K040452VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096Pharmacia Deutschland GmbH2004-05-11
K030701IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISAImmco Diagnostics, Inc.2003-09-09
K030702IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISAImmco Diagnostics, Inc.2003-09-09