MID · System, Test, Anticardiolipin Immunological
Immunology · 21 CFR 866.5660 · Class 2
Overview
| Product Code | MID |
|---|---|
| Device Name | System, Test, Anticardiolipin Immunological |
| Regulation | 21 CFR 866.5660 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 94)
Showing 20 most recent of 94 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | Inova Diagnostics, Inc. | Dec 17, 2024 | SESE |
| K131821 | ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY | Phadia US, Inc. | Dec 23, 2013 | SESE |
| K130528 | BIOPLEX 2200 APLS IGM | Bio-Rad Laboratories | Oct 21, 2013 | SESE |
| K120817 | QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA | Inova Diagnostics, Inc. | Feb 26, 2013 | SESE |
| K113020 | IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS | Immco Diagnostics, Inc. | Oct 25, 2012 | SESE |
| K103834 | BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS | Bio-Rad Laboratories | Mar 30, 2012 | SESE |
| K102425 | ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM | Zeus Scientific, Inc. | Dec 12, 2011 | SESE |
| K091845 | CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM | Phadia US, Inc. | Jun 7, 2010 | SESE |
| K092181 | HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS | Instrumentation Laboratory CO | Mar 11, 2010 | SESE |
| K060176 | EL-ACL SCREEN; EL-ACL IGM, IGG, IGA | Theratest Laboratories, Inc. | Feb 7, 2006 | SESE |
| K040463 | AESKULISA CARDIOLIPIN AGM | Aesku, Inc. | May 12, 2004 | SESE |
| K032868 | REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 | Corgenix, Inc. | Oct 14, 2003 | SESE |
| K032240 | BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT | The Binding Site, Ltd. | Sep 29, 2003 | SESE |
| K030741 | AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA | Hycor Biomedical , Ltd. | May 1, 2003 | SESE |
| K024196 | REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT | Corgenix, Inc. | Jan 3, 2003 | SESE |
| K024195 | MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT | Corgenix, Inc. | Jan 3, 2003 | SESE |
| K023433 | VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896 | Pharmacia Diagnostics GmbH & Co. KG | Nov 13, 2002 | SESE |
| K022992 | REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001 | Corgenix, Inc. | Sep 25, 2002 | SESE |
| K022990 | REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001 | Corgenix, Inc. | Sep 25, 2002 | SESE |
| K021398 | APL IGA ELISA KIT | Louisville Apl Diagnostics, Inc. | Aug 27, 2002 | SESE |
Top Applicants
- Zeus Scientific, Inc. — 9 clearances
- Inova Diagnostics, Inc. — 9 clearances
- Corgenix, Inc. — 8 clearances
- Elias U.S.A., Inc. — 7 clearances
- The Binding Site, Ltd. — 5 clearances
