MID · Class II · 21 CFR 866.5660

FDA Product Code MID: System, Test, Anticardiolipin Immunological

Leading manufacturers include Zeus Scientific, Inc., Inova Diagnostics, Inc. and Corgenix, 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
1–24 of 94
Cleared Dec 17, 2024
Aptiva APS IgG Reagent
K223093
Inova Diagnostics, Inc.
Immunology · 809d
Cleared Dec 23, 2013
ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
K131821
Phadia US, Inc.
Immunology · 186d
Cleared Oct 21, 2013
BIOPLEX 2200 APLS IGM
K130528
Bio-Rad Laboratories
Immunology · 234d
Cleared Feb 26, 2013
QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA
K120817
Inova Diagnostics, Inc.
Immunology · 344d
Cleared Oct 25, 2012
IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS
K113020
Immco Diagnostics, Inc.
Immunology · 380d
Cleared Mar 30, 2012
BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS
K103834
Bio-Rad Laboratories
Immunology · 456d
Cleared Dec 12, 2011
ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM
K102425
Zeus Scientific, Inc.
Immunology · 474d
Cleared Jun 07, 2010
CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
K091845
Phadia US, Inc.
Immunology · 350d
Cleared Mar 11, 2010
HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS
K092181
Instrumentation Laboratory CO
Immunology · 233d
Cleared Feb 07, 2006
EL-ACL SCREEN
K060176
Theratest Laboratories, Inc.
Immunology · 15d
Cleared Oct 14, 2003
REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139
K032868
Corgenix, Inc.
Immunology · 29d
Cleared Sep 29, 2003
BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT
K032240
The Binding Site, Ltd.
Immunology · 70d
Cleared Jan 03, 2003
MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT
K024195
Corgenix, Inc.
Immunology · 14d
Cleared Jan 03, 2003
REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
K024196
Corgenix, Inc.
Immunology · 14d
Cleared Sep 25, 2002
REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001
K022990
Corgenix, Inc.
Immunology · 16d
Cleared Sep 25, 2002
REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001
K022992
Corgenix, Inc.
Immunology · 16d
Cleared Mar 06, 2002
DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T
K020156
Axis-Shield Diagnostics, Ltd.
Immunology · 48d
Cleared Oct 26, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM
K012449
Diamedix Corp.
Immunology · 86d
Cleared Oct 26, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM
K012450
Diamedix Corp.
Immunology · 86d
Cleared Sep 20, 2001
REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT
K013018
Corgenix, Inc.
Immunology · 13d
Cleared Aug 23, 2001
MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
K012567
Corgenix, Inc.
Immunology · 14d
Cleared Aug 20, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM
K012053
Diamedix Corp.
Immunology · 49d
Cleared Nov 27, 2000
ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM
K003069
Quest Intl., Inc.
Immunology · 56d
Cleared Apr 26, 2000
REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT
K000920
Corgenix, Inc.
Immunology · 35d

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 →