FDA Product Code MID: System, Test, Anticardiolipin Immunological
Leading manufacturers include Zeus Scientific, Inc., Inova Diagnostics, Inc. and Elias U.S.A., Inc..
94
Total
94
Cleared
155d
Avg days
1991
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
809d
recently vs 147d historically
FDA 510(k) Cleared System, Test, Anticardiolipin Immunological Devices (Product Code MID)
94 devices
Cleared
Dec 17, 2024
Aptiva APS IgG Reagent
Inova Diagnostics, Inc.
Immunology
809d
Cleared
Oct 21, 2013
BIOPLEX 2200 APLS IGM
Bio-Rad Laboratories
Immunology
234d
Cleared
Feb 26, 2013
QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA
Inova Diagnostics, Inc.
Immunology
344d
Cleared
Oct 25, 2012
IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS
Immco Diagnostics, Inc.
Immunology
380d
Cleared
Mar 30, 2012
BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS
Bio-Rad Laboratories
Immunology
456d
Cleared
Dec 12, 2011
ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM
Zeus Scientific, Inc.
Immunology
474d
Cleared
Mar 11, 2010
HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS
Instrumentation Laboratory CO
Immunology
233d
Cleared
Sep 29, 2003
BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT
The Binding Site, Ltd.
Immunology
70d
Cleared
Oct 26, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM
Diamedix Corp.
Immunology
86d
Cleared
Oct 26, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM
Diamedix Corp.
Immunology
86d
Cleared
Aug 20, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM
Diamedix Corp.
Immunology
49d
Cleared
Feb 05, 1999
ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST
The Binding Site, Ltd.
Immunology
107d
Cleared
Feb 05, 1999
ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT
The Binding Site, Ltd.
Immunology
107d
Cleared
Feb 05, 1999
ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT
The Binding Site, Ltd.
Immunology
107d
Cleared
Feb 05, 1999
ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT
The Binding Site, Ltd.
Immunology
107d
Cleared
Dec 22, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM
Zeus Scientific, Inc.
Immunology
32d
Cleared
Dec 17, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM
Zeus Scientific, Inc.
Immunology
27d
Cleared
Dec 17, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F
Zeus Scientific, Inc.
Immunology
13d
Cleared
Jun 02, 1998
ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM
Zeus Scientific, Inc.
Immunology
76d
Cleared
Jun 02, 1998
ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM
Zeus Scientific, Inc.
Immunology
75d
Cleared
May 18, 1998
ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM
Zeus Scientific, Inc.
Immunology
60d
Cleared
Oct 29, 1997
ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS
Zeus Scientific, Inc.
Immunology
64d
Cleared
Jul 23, 1997
ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM
Zeus Scientific, Inc.
Immunology
70d
Cleared
Jun 11, 1997
ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA
Immco Diagnostics, Inc.
Immunology
145d
About Product Code MID - Regulatory Context
510(k) Submission Activity
94 total 510(k) submissions under product code MID since 1991, with 94 receiving FDA clearance (average review time: 155 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - MID Product Code
Recent submissions under MID have taken an average of 809 days to reach a decision - up from 147 days historically. Manufacturers should account for longer review timelines in current project planning.
MID devices are reviewed by the Immunology panel. Browse all Immunology devices →