Product Code: MID FDA class 2 21 CFR 866.5660

System, Test, Anticardiolipin Immunological

Immunology

The Anticardiolipin Immunological Test System is an in vitro diagnostic device used to detect antibodies against cardiolipin, a phospholipid antigen, in patient serum or plasma, which is a key marker in the diagnosis of antiphospholipid syndrome and related autoimmune thrombotic conditions. It is classified as a Class 2 device under 21 CFR 866.5660, covering antigen and antibody test systems for autoimmune diseases, and requires 510(k) premarket notification. It falls within the Immunology specialty and is not flagged as an implant or life-sustaining device.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code MID in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: MID
Device Class: FDA class 2
Regulation Number: 866.5660
Medical Specialty: Immunology
Review Panel: IM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 94 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K223093	Aptiva APS IgG Reagent; Aptiva APS IgM Reagent	Dec 17, 2024	Substantially Equivalent	Inova Diagnostics, Inc.
K131821	ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY	Dec 23, 2013	Substantially Equivalent	Phadia US, Inc.
K130528	BIOPLEX 2200 APLS IGM	Oct 21, 2013	Substantially Equivalent	Bio-Rad Laboratories
K120817	QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA	Feb 26, 2013	Substantially Equivalent	Inova Diagnostics, Inc.
K113020	IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG/IGM ANTIBODY (ACA) ELISAS	Oct 25, 2012	Substantially Equivalent	Immco Diagnostics, Inc.
K103834	BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS	Mar 30, 2012	Substantially Equivalent	Bio-Rad Laboratories
K102425	ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM	Dec 12, 2011	Substantially Equivalent	Zeus Scientific, Inc.
K091845	CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM	Jun 07, 2010	Substantially Equivalent	Phadia US, Inc.
K092181	HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS	Mar 11, 2010	Substantially Equivalent	Instrumentation Laboratory CO
K060176	EL-ACL SCREEN; EL-ACL IGM, IGG, IGA	Feb 07, 2006	Substantially Equivalent	Theratest Laboratories, Inc.
K040463	AESKULISA CARDIOLIPIN AGM	May 12, 2004	Substantially Equivalent	Aesku, Inc.
K032868	REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139	Oct 14, 2003	Substantially Equivalent	Corgenix, Inc.
K032240	BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT	Sep 29, 2003	Substantially Equivalent	The Binding Site, Ltd.
K030741	AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA	May 01, 2003	Substantially Equivalent	Hycor Biomedical , Ltd.
K024196	REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT	Jan 03, 2003	Substantially Equivalent	Corgenix, Inc.
K024195	MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT	Jan 03, 2003	Substantially Equivalent	Corgenix, Inc.
K023433	VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896	Nov 13, 2002	Substantially Equivalent	Pharmacia Diagnostics GmbH & Co. KG
K022992	REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT, MODEL 023-001	Sep 25, 2002	Substantially Equivalent	Corgenix, Inc.
K022990	REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001	Sep 25, 2002	Substantially Equivalent	Corgenix, Inc.
K021398	APL IGA ELISA KIT	Aug 27, 2002	Substantially Equivalent	Louisville Apl Diagnostics, Inc.
K021192	QACA IGG/IGM ELISA KIT HRP	May 16, 2002	Substantially Equivalent	Cheshire Diagnostics , Ltd.
K020758	VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696	May 02, 2002	Substantially Equivalent	Pharmacia Deutschland GmbH
K020757	VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796	May 02, 2002	Substantially Equivalent	Pharmacia Deutschland GmbH
K020752	VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596	May 02, 2002	Substantially Equivalent	Pharmacia Deutschland GmbH
K020241	QACA IGG/IGM ELISA KIT	Mar 13, 2002	Substantially Equivalent	Cheshire Diagnostics , Ltd.
K020156	DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T	Mar 06, 2002	Substantially Equivalent	Axis-Shield Diagnostics, Ltd.
K012450	DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM	Oct 26, 2001	Substantially Equivalent	Diamedix Corp.
K012449	DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM	Oct 26, 2001	Substantially Equivalent	Diamedix Corp.
K013018	REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT	Sep 20, 2001	Substantially Equivalent	Corgenix, Inc.
K012567	MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT	Aug 23, 2001	Substantially Equivalent	Corgenix, Inc.
K012053	DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM	Aug 20, 2001	Substantially Equivalent	Diamedix Corp.
K003069	ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM	Nov 27, 2000	Substantially Equivalent	Quest Intl., Inc.
K001981	DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500	Aug 21, 2000	Substantially Equivalent	Axis-Shield , Ltd.
K001574	DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600	Jun 09, 2000	Substantially Equivalent	Axis-Shield
K000920	REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KIT	Apr 26, 2000	Substantially Equivalent	Corgenix, Inc.
K993085	AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA	Feb 01, 2000	Substantially Equivalent	Cogent Diagnotics , Ltd.
K992449	AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA	Nov 24, 1999	Substantially Equivalent	Cogent Diagnotics , Ltd.
K992440	AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA	Sep 21, 1999	Substantially Equivalent	Cogent Diagnotics , Ltd.
K984102	ACL/APS FACS KIT	Mar 18, 1999	Substantially Equivalent	Louisville Apl Diagnostics, Inc.
K983696	ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT	Feb 05, 1999	Substantially Equivalent	The Binding Site, Ltd.
K983695	ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT	Feb 05, 1999	Substantially Equivalent	The Binding Site, Ltd.
K983694	ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT	Feb 05, 1999	Substantially Equivalent	The Binding Site, Ltd.
K983692	ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST	Feb 05, 1999	Substantially Equivalent	The Binding Site, Ltd.
K984173	THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM	Dec 22, 1998	Substantially Equivalent	Zeus Scientific, Inc.
K984347	THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F	Dec 17, 1998	Substantially Equivalent	Zeus Scientific, Inc.
K984175	THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM	Dec 17, 1998	Substantially Equivalent	Zeus Scientific, Inc.
K981021	ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM	Jun 02, 1998	Substantially Equivalent	Zeus Scientific, Inc.
K981014	ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM	Jun 02, 1998	Substantially Equivalent	Zeus Scientific, Inc.
K981020	ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM	May 18, 1998	Substantially Equivalent	Zeus Scientific, Inc.
K973196	ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS	Oct 29, 1997	Substantially Equivalent	Zeus Scientific, Inc.
K971784	ZEUS SCIENTIFIC, INC., ANTICARDIOLIPIN IGG/IGM ELISA TEST SYSTEM	Jul 23, 1997	Substantially Equivalent	Zeus Scientific, Inc.
K970177	ANTI-CARDIOLIPIN ANTIBODY (ACA) SCREEN ELISA	Jun 11, 1997	Substantially Equivalent	Immco Diagnostics, Inc.
K971039	HEMAGEN ANTI CARDIOLIPIN SCREEN	Jun 03, 1997	Substantially Equivalent	Hemagen Diagnostics, Inc.
K962926	ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY	Oct 10, 1996	Substantially Equivalent	American Laboratory Products Co., Ltd.
K962469	ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY	Sep 09, 1996	Substantially Equivalent	American Laboratory Products Co., Ltd.
K955303	DIASTAT ANTI-CARDIOLIPIN KIT	May 30, 1996	Substantially Equivalent	Shield Diagnostics, Ltd.
K955449	ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY	May 23, 1996	Substantially Equivalent	American Laboratory Products Co., Ltd.
K952523	CARDIOLIPIN IGG EIA TEST KIT	Feb 09, 1996	Substantially Equivalent	Immunoprobe, Inc.
K952522	CARDIOLIPIN IGA EIA TEST SYSTEM	Feb 09, 1996	Substantially Equivalent	Immunoprobe, Inc.
K952521	CARDIOLIPIN IGM EIA TEST SYSTEM	Feb 09, 1996	Substantially Equivalent	Immunoprobe, Inc.
K946217	CARDIOLIPIN M EIA TEST SYSTEM	Jan 24, 1996	Substantially Equivalent	Hogan & Hartson
K946216	CARDIOLIPIN A EIA TEST SYSTEM	Jan 24, 1996	Substantially Equivalent	Hogan & Hartson
K946215	CARDIOLIPIN G EIA TEST SYSTEM	Jan 24, 1996	Substantially Equivalent	Hogan & Hartson
K952287	REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT	Dec 18, 1995	Substantially Equivalent	Reaads Medical Products, Inc.
K951363	CARDIOLIPIN IGG,M,A EIA TEST SYSTEM	Oct 13, 1995	Substantially Equivalent	Immunoprobe, Inc.
K951187	VARELISA CARDIOLIPIN ABS SCREEN	Oct 02, 1995	Substantially Equivalent	Elias U.S.A., Inc.
K952520	CARDIOLIPIN IGG,M,A EIA TEST KIT	Sep 15, 1995	Substantially Equivalent	Immunoprobe, Inc.
K953366	QUANTA LITE IGA ACA (HRP)	Sep 01, 1995	Substantially Equivalent	Inova Diagnostics, Inc.
K953291	QUANTA LITE ACA SCREEN (HRP)	Aug 29, 1995	Substantially Equivalent	Inova Diagnostics, Inc.
K946385	QUANTA LITE ACA IGM (HRP)	Jul 18, 1995	Substantially Equivalent	Inova Diagnostics, Inc.
K946034	QUANTA LITE(TM) IGG (HRP)	Jul 18, 1995	Substantially Equivalent	Inova Diagnostics, Inc.
K933788	ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST	Mar 07, 1995	Substantially Equivalent	Immco Diagnostics, Inc.
K933786	ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST	Mar 07, 1995	Substantially Equivalent	Immco Diagnostics, Inc.
K933784	ANTI-CARDIOLIPIN ANTIBODY (IGA-ACA)TEST)	Mar 07, 1995	Substantially Equivalent	Immco Diagnostics, Inc.
K933588	APHLELISA KIT	Oct 13, 1994	Substantially Equivalent	Louisville Apl Diagnostics, Inc.
K940403	ELIAS CARDIOLIPIN ANTIBODIES	Sep 20, 1994	Substantially Equivalent	Elias U.S.A., Inc.
K941840	HEMAGEN ACL IGA CALIBRATOR	Jun 30, 1994	Substantially Equivalent	Hemagen Diagnostics, Inc.
K935288	SYNELISA CARDIOLIPIN ANTIBODIES	Jan 24, 1994	Substantially Equivalent	Elias U.S.A., Inc.
K933393	ELIAS CARDIOLIPIN IGG ANTIBODIES	Dec 08, 1993	Substantially Equivalent	Elias U.S.A., Inc.
K933392	ELIAS CARDIOLIPIN IGM ANTIBODIES	Dec 08, 1993	Substantially Equivalent	Elias U.S.A., Inc.
K932373	HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0	Jul 16, 1993	Substantially Equivalent	Hemagen Diagnostics, Inc.
K932225	ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM	Jul 06, 1993	Substantially Equivalent	Immuno Concepts, Inc.
K924421	SYNELISA CARDIOLIPIN ANTIBODIES	Nov 30, 1992	Substantially Equivalent	Elias U.S.A., Inc.
K922351	QUANTA LITE(TM) IGA ACA	Sep 29, 1992	Substantially Equivalent	Inova Diagnostics, Inc.
K923320	QUANTA LITE ACA SCREEN	Sep 28, 1992	Substantially Equivalent	Inova Diagnostics, Inc.
K923886	DIASTAT TOTAL ANTI-CARDIOLIPIN KIT	Sep 25, 1992	Substantially Equivalent	Shield Diagnostics, Ltd.
K920401	IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST	Aug 20, 1992	Substantially Equivalent	General Biometrics, Inc.
K920400	IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST	Aug 20, 1992	Substantially Equivalent	General Biometrics, Inc.
K921265	DIASTAT ANTI-CARDIOLIPIN KIT	Aug 03, 1992	Substantially Equivalent	Shield Diagnostics, Ltd.
K921250	SYNELISA CARDIOLIPIN ANTIBODIES	Jun 04, 1992	Substantially Equivalent	Elias U.S.A., Inc.
K914405	READS(R) IGA ANTI-CARDIOLIPIN TEST KIT	Dec 18, 1991	Substantially Equivalent	Reads Medical Products, Inc.
K911661	ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM	Dec 09, 1991	Substantially Equivalent	Immuno Concepts, Inc.
K913054	3M ANTI-CARDIOLIPIN FAST(TM) TEST	Nov 27, 1991	Substantially Equivalent	3M Diagnostic Systems, Inc.
K911680	QUANTA LITE(TM) ACA	Nov 19, 1991	Substantially Equivalent	Inova Diagnostics, Inc.