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

LFZ — Predicate Candidate Screening

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

174 daysmedian FDA review time

417 days90th percentile

58clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K220949	Architect CMV IgG	Abbott Laboratories	2022-10-27	209	0
K220911	Elecsys CMV IgG	Roche Diagnostics	2022-10-12	197	0
K181213	ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Cont	Siemens Healthcare Diagnostics, Inc.	2018-07-30	84	0
K163569	Elecsys CMV IgM	Roche Diagnostics	2017-03-17	88	0
K162969	LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set	DiaSorin, Inc.	2017-01-06	74	0
K142133	ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM	Roche Diagnostics	2014-10-24	81	0
K131605	ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY	Roche Diagnostics	2014-02-28	270	0
K040290	DIASORIN LIAISON CMV IGM/IGG	Diasorin S.P.A	2005-06-01	481	0
K993952	IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6	Diagnostic Products Corp.	1999-12-16	24	0
K982485	SERAQUEST CMV IGM	Quest Intl., Inc.	1999-01-13	180	2
K984139	THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST	Zeus Scientific, Inc.	1999-01-11	54	0
K983803	THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST	Zeus Scientific, Inc.	1998-12-14	47	0
K982027	MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY	DiaSorin, Inc.	1998-11-25	176	0
K981163	DIAMEDIX IS-CMV IGG TEST SYSTEM	Diamedix Corp.	1998-09-21	174	0
K971335	QUANTA LITE CMV IGG ELISA	Inova Diagnostics, Inc.	1997-12-01	235	0
K954301	ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)	Abbott Laboratories	1997-03-24	579	0
K944438	HEMAGEN CMV IGG KIT	Hemagen Diagnostics, Inc.	1997-02-20	892	0
K960434	INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530	Incstar Corp.	1996-10-17	260	0
K963084	OPUS CMV TEST SYSTEM-MODIFICATION	Behring Diagnostics, Inc.	1996-10-09	62	0
K953943	AXSYM CMV IGG ANTIBODY ASSAY	Abbott Laboratories	1996-09-20	396	2
K955361	INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY	Incstar Corp.	1996-07-22	243	0
K955360	INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY	Incstar Corp.	1996-07-22	243	0
K950672	IMMULITE CMV IGG	Diagnostic Products Corp.	1996-06-17	490	0
K954191	SERAQUEST CMV IGG	Quest Intl., Inc.	1996-02-23	170	0
K933389	OPUS CMV-G	Pb Diagnostic Systems, Inc.	1994-06-28	351	0
K922582	BARTELS CYTOMEGALOVIRUS IGG EIA	Baxter Diagnostics, Inc.	1993-04-08	316	0
K924096	CMV ELISA TEST SYSTEM	Zeus Scientific, Inc.	1993-04-02	232	1
K920661	VIDAS CMV IGG ASSAY	Vitek Systems, Inc.	1993-02-12	365	1
K921011	PHARMACIA CMV IGM ELISA	Pharmacia Diagnostics, Inc.	1992-07-27	146	0
K915479	CAPTIA CMV-TA	Mercia Diagnostics , Ltd.	1992-05-04	150	0
K913910	ENZYGNOST(R) ANTI-CMV IGG	Behring Diagnostics, Inc.	1992-04-28	242	0
K913693	ENZYGNOST(R) ANTI-CMV/IGM	Behring Diagnostics, Inc.	1992-02-27	192	0
K915892	CMV IGG ELISA TEST	Gull Laboratories, Inc.	1992-02-14	52	0
K901485	ENZYGNOST ANTI-CMV/IGG + IGM	Behring Diagnostics, Inc.	1991-05-20	417	0
K904456	CYTOMEGALOVIRUS (CMV) ELISA	Virotech, Inc.	1991-04-03	184	0
K905077	ORTHO CMV-M ANTIBODY ELISA TEST	Ortho Diagnostic Systems, Inc.	1990-12-17	34	0
K905078	ORTHO CMV-G ANTIBODY ELISA TEST	Ortho Diagnostic Systems, Inc.	1990-12-17	34	0
K903807	CMV IGM ELISA TEST	Gull Laboratories, Inc.	1990-12-17	119	0
K900473	IMX CMV IGM ANTIBODY ASSAY	Abbott Laboratories	1990-07-27	176	0
K900474	IMX CMV IGG ANTIBODY ASSAY	Abbott Laboratories	1990-07-27	176	0
K900796	CMV IGG ELISA TEST	Gull Laboratories, Inc.	1990-05-02	71	0
K896295	CAPTIA(R) CMV-M	Mercia Diagnostics , Ltd.	1990-03-06	126	0
K896194	CAPTIA(R) CMV-G	Mercia Diagnostics , Ltd.	1990-03-06	132	0
K896355	CMV IGM ELISA TEST SYSTEM	Zeus Scientific, Inc.	1990-02-27	113	0
K893230	DETECTADOT TM SYSTEM 2000 CMV IGM TEST	Gull Laboratories, Inc.	1989-12-18	234	0
K891393	ORGENICS IMMUNOCOMB(TM) CMV IGG ANTIBODY TEST KIT	Orgenics, Ltd.	1989-06-23	101	0
K890610	VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM	Organon Teknika Corp.	1989-06-23	136	0
K891081	CMV ELISA TEST SYSTEM	Zeus Scientific, Inc.	1989-06-02	93	1
K884842	CMV-CUBE(TM)	Difco Laboratories, Inc.	1989-04-11	141	0
K884248	MODIFIED DDI SEROCARD CMV IGG TEST KIT	Disease Detection International, Inc.	1989-04-10	181	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