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
Cleared
Dec 17, 2024
Aptiva APS IgG Reagent
Inova Diagnostics, Inc.
Immunology
809d
Cleared
Dec 23, 2013
ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
Phadia US, Inc.
Immunology
186d
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
Jun 07, 2010
CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM
Phadia US, Inc.
Immunology
350d
Cleared
Mar 11, 2010
HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS
Instrumentation Laboratory CO
Immunology
233d
Cleared
Feb 07, 2006
EL-ACL SCREEN
Theratest Laboratories, Inc.
Immunology
15d
Cleared
May 12, 2004
AESKULISA CARDIOLIPIN AGM
Aesku, Inc.
Immunology
79d
Cleared
Oct 14, 2003
REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139
Corgenix, Inc.
Immunology
29d
Cleared
Sep 29, 2003
BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT
The Binding Site, Ltd.
Immunology
70d
Cleared
May 01, 2003
AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA
Hycor Biomedical , Ltd.
Immunology
52d
Cleared
Jan 03, 2003
MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT
Corgenix, Inc.
Immunology
14d
Cleared
Jan 03, 2003
REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT
Corgenix, Inc.
Immunology
14d
Cleared
Nov 13, 2002
VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896
Pharmacia Diagnostics GmbH & Co. KG
Immunology
29d
Cleared
Sep 25, 2002
REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001
Corgenix, Inc.
Immunology
16d
Cleared
Sep 25, 2002
REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001
Corgenix, Inc.
Immunology
16d
Cleared
Aug 27, 2002
APL IGA ELISA KIT
Louisville Apl Diagnostics, Inc.
Immunology
117d
Cleared
May 16, 2002
QACA IGG/IGM ELISA KIT HRP
Cheshire Diagnostics , Ltd.
Immunology
31d
Cleared
May 02, 2002
VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596
Pharmacia Deutschland GmbH
Immunology
56d
Cleared
May 02, 2002
VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796
Pharmacia Deutschland GmbH
Immunology
56d
Cleared
May 02, 2002
VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696
Pharmacia Deutschland GmbH
Immunology
56d
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 →