Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

MID — Predicate Candidate Screening

94 FDA 510(k) clearances under this product code; the 50 most recent screened below.

90 daysmedian FDA review time

399 days90th percentile

94clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K223093	Aptiva APS IgG Reagent; Aptiva APS IgM Reagent	Inova Diagnostics, Inc.	2024-12-17	809	0
K131821	ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY	Phadia US, Inc.	2013-12-23	186	0
K130528	BIOPLEX 2200 APLS IGM	Bio-Rad Laboratories	2013-10-21	234	1
K120817	QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA	Inova Diagnostics, Inc.	2013-02-26	344	0
K113020	IMMULISA ENHANCED (TM) CARDIOLIPIN IGA, IGG, IGM AND IGA/IGG	Immco Diagnostics, Inc.	2012-10-25	380	0
K103834	BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL	Bio-Rad Laboratories	2012-03-30	456	0
K102425	ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM	Zeus Scientific, Inc.	2011-12-12	474	0
K091845	CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM	Phadia US, Inc.	2010-06-07	350	0
K092181	HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROL	Instrumentation Laboratory CO	2010-03-11	233	0
K060176	EL-ACL SCREEN; EL-ACL IGM, IGG, IGA	Theratest Laboratories, Inc.	2006-02-07	15	1
K040463	AESKULISA CARDIOLIPIN AGM	Aesku, Inc.	2004-05-12	79	0
K032868	REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, M	Corgenix, Inc.	2003-10-14	29	1
K032240	BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZ	The Binding Site, Ltd.	2003-09-29	70	0
K030741	AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA	Hycor Biomedical , Ltd.	2003-05-01	52	0
K024195	MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUAN	Corgenix, Inc.	2003-01-03	14	0
K024196	REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TES	Corgenix, Inc.	2003-01-03	14	0
K023433	VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 158	Pharmacia Diagnostics GmbH & Co. KG	2002-11-13	29	0
K022992	REAADS ANTI-CARDIOLIPIN IGG/IGM SEMI-QUANTITATIVE TEST KIT,	Corgenix, Inc.	2002-09-25	16	0
K022990	REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODE	Corgenix, Inc.	2002-09-25	16	0
K021398	APL IGA ELISA KIT	Louisville Apl Diagnostics, Inc.	2002-08-27	117	0
K021192	QACA IGG/IGM ELISA KIT HRP	Cheshire Diagnostics , Ltd.	2002-05-16	31	0
K020752	VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596	Pharmacia Deutschland GmbH	2002-05-02	56	0
K020757	VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796	Pharmacia Deutschland GmbH	2002-05-02	56	0
K020758	VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696	Pharmacia Deutschland GmbH	2002-05-02	56	1
K020241	QACA IGG/IGM ELISA KIT	Cheshire Diagnostics , Ltd.	2002-03-13	49	0
K020156	DIASTAT TOTAL ANTI-CARDIOLIPIN, MODEL FCAR 100T	Axis-Shield Diagnostics, Ltd.	2002-03-06	48	0
K012449	DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM	Diamedix Corp.	2001-10-26	86	0
K012450	DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM	Diamedix Corp.	2001-10-26	86	0
K013018	REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT	Corgenix, Inc.	2001-09-20	13	0
K012567	MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI	Corgenix, Inc.	2001-08-23	14	0
K012053	DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM	Diamedix Corp.	2001-08-20	49	0
K003069	ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST	Quest Intl., Inc.	2000-11-27	56	0
K001981	DIASTAT ANTI-CARDIOLIPIN IGA, MODEL FCAR 500	Axis-Shield , Ltd.	2000-08-21	53	2
K001574	DIASTAT ANTI-CARDIOLIPIN IGG/IGM, MODEL FCAR 600	Axis-Shield	2000-06-09	18	2
K000920	REAADS IGA ANTI-PHOSPHATIDYLSERINE SEMI-QUANTITATIVE TEST KI	Corgenix, Inc.	2000-04-26	35	0
K993085	AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA	Cogent Diagnotics , Ltd.	2000-02-01	139	0
K992449	AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA	Cogent Diagnotics , Ltd.	1999-11-24	125	0
K992440	AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA	Cogent Diagnotics , Ltd.	1999-09-21	61	0
K984102	ACL/APS FACS KIT	Louisville Apl Diagnostics, Inc.	1999-03-18	121	0
K983694	ANTICARDIOLIPIN IGM SCREEN EIA DIAGNOSTIC TEST KIT	The Binding Site, Ltd.	1999-02-05	107	1
K983692	ANTICARDIOLIPIN IGG SCREEN EIA DIAGNOSTIC TEST	The Binding Site, Ltd.	1999-02-05	107	0
K983695	ANTICARDIOLIPIN IGGAM SCREEN EIA DIAGNOSTIC TEST KIT	The Binding Site, Ltd.	1999-02-05	107	0
K983696	ANTICARDIOLIPIN IGA SCREEN EIA DIAGNOSTIC TEST KIT	The Binding Site, Ltd.	1999-02-05	107	0
K984173	THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IG	Zeus Scientific, Inc.	1998-12-22	32	1
K984347	THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IG	Zeus Scientific, Inc.	1998-12-17	13	0
K984175	THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IG	Zeus Scientific, Inc.	1998-12-17	27	0
K981021	ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM	Zeus Scientific, Inc.	1998-06-02	75	1
K981014	ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM	Zeus Scientific, Inc.	1998-06-02	76	0
K981020	ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM	Zeus Scientific, Inc.	1998-05-18	60	0
K973196	ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS	Zeus Scientific, Inc.	1997-10-29	64	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda