Product code MID
- Device name
- System, Test, Anticardiolipin Immunological
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5660
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | Inova Diagnostics, Inc. | 2024-12-17 |
| K131821 | ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY | Phadia US, Inc. | 2013-12-23 |
| K130528 | BIOPLEX 2200 APLS IGM | Bio-Rad Laboratories | 2013-10-21 |
| K120817 | QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA | Inova Diagnostics, Inc. | 2013-02-26 |
| K113020 | IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS | Immco Diagnostics, Inc. | 2012-10-25 |
| K103834 | BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS | Bio-Rad Laboratories | 2012-03-30 |
| K102425 | ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM | Zeus Scientific, Inc. | 2011-12-12 |
| K091845 | CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM | Phadia US, Inc. | 2010-06-07 |
| K092181 | HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS | Instrumentation Laboratory CO | 2010-03-11 |
| K060176 | EL-ACL SCREEN; EL-ACL IGM, IGG, IGA | Theratest Laboratories, Inc. | 2006-02-07 |
| K040463 | AESKULISA CARDIOLIPIN AGM | Aesku, Inc. | 2004-05-12 |
| K032868 | REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 | Corgenix, Inc. | 2003-10-14 |
| K032240 | BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT | The Binding Site, Ltd. | 2003-09-29 |
| K030741 | AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA | Hycor Biomedical , Ltd. | 2003-05-01 |
| K024196 | REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT | Corgenix, Inc. | 2003-01-03 |
| K024195 | MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT | Corgenix, Inc. | 2003-01-03 |
| K023433 | VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896 | Pharmacia Diagnostics GmbH & Co. KG | 2002-11-13 |
| K022990 | REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001 | Corgenix, Inc. | 2002-09-25 |
| K022992 | REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001 | Corgenix, Inc. | 2002-09-25 |
| K021398 | APL IGA ELISA KIT | Louisville Apl Diagnostics, Inc. | 2002-08-27 |
| K021192 | QACA IGG/IGM ELISA KIT HRP | Cheshire Diagnostics , Ltd. | 2002-05-16 |
| K020758 | VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696 | Pharmacia Deutschland GmbH | 2002-05-02 |
| K020757 | VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796 | Pharmacia Deutschland GmbH | 2002-05-02 |
| K020752 | VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596 | Pharmacia Deutschland GmbH | 2002-05-02 |
| K020241 | QACA IGG/IGM ELISA KIT | Cheshire Diagnostics , Ltd. | 2002-03-13 |
| K020156 | DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T | Axis-Shield Diagnostics, Ltd. | 2002-03-06 |
| K012449 | DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM | Diamedix Corp. | 2001-10-26 |
| K012450 | DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM | Diamedix Corp. | 2001-10-26 |
| K013018 | REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT | Corgenix, Inc. | 2001-09-20 |
| K012567 | MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT | Corgenix, Inc. | 2001-08-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08426951011193 | HemosIL CL Anti-Cardiolipin IgM | INSTRUMENTATION LABORATORY COMPANY | 2026-04-08 |
| 00845714002922 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 00845714002786 | IMMCO DIAGNOSTICS | IMMCO DIAGNOSTICS, INC. | 2016-12-09 |
| 07333066014722 | EliA Cardiolipin IgG Well | Phadia AB | 2016-09-23 |
| 07333066014715 | EliA Cardiolipin IgA Well | Phadia AB | 2016-09-23 |
| 00847865012973 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865012966 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865012522 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865012515 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865012508 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865000666 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 08426950594901 | QUANTA Lite® Phosphatidylserine IgM ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950596813 | QUANTA Flash® aCL IgA Reagents | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950595670 | QUANTA Lite® Phosphatidylserine IgG ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950595601 | QUANTA Lite® Phosphatidylserine IgA ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950448389 | QUANTA Lite® ACA IgA III | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950594666 | QUANTA Lite® ACA IgA III ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950594635 | QUANTA Lite® ACA IgG III ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950594536 | QUANTA Lite® ACA IgM III ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950594178 | QUANTA LITE® ACA IgA III ELISA Bulk Pack Kit (Lab Corp) | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950594123 | QUANTA LITE® ACA IgG III ELISA Bulk Pack Kit (Lab Corp) | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950594062 | QUANTA LITE® ACA IgM III ELISA Bulk Pack Kit (Lab Corp) | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950593430 | QUANTA Lite® Phosphatidylserine IgM ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950593294 | QUANTA Lite® Phosphatidylserine IgA ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950593249 | QUANTA Lite® Phosphatidylserine IgG ELISA | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950544210 | QUANTA Flash® aCL IgM Reagents | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950544203 | QUANTA Flash® aCL IgG Reagents | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950485988 | QUANTA Lite® ACA IgM III | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950472773 | QUANTA Lite® ACA IgG III | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950454489 | QUANTA Lite® ACA Screen III | INOVA DIAGNOSTICS, INC. | 2016-08-31 |