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

LJO — Predicate Candidate Screening

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

148 daysmedian FDA review time

272 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K203612	Capture-CMV	Immucor, Inc.	2021-03-22	102
K183571	Capture-CMV	Immucor, Inc.	2019-02-04	45
K001767	DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM	Diamedix Corp.	2000-08-07	56
K974901	HYBRID CAPTURE SYSTEM CMV DNA ASSAY	Digene Corp.	1998-09-29	272
K974456	CMVGEN	Instrumentation Laboratory CO	1998-05-01	157
K951851	ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMU	E.I. Dupont DE Nemours & Co., Inc.	1996-07-24	460
K955799	COPALIS CMV TOTAL ANTIBODY ASSAY	Sienna Biotech, Inc.	1996-07-10	201
K920222	HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS	Akers Research Corp.	1992-07-27	193
K910003	CYTOMEGALOVIRUS ANTIBODY SCREEN	Immucor, Inc.	1991-03-20	77
K852494	CMV-IHA	Hillcrest Biologicals	1985-09-16	96
K841520	CMV LATEX AGGLUTINATION TEST KIT	Bd Becton Dickinson Vacutainer Systems Preanalytic	1984-09-07	148
K822965	CETUS CMV IHA	Cetus Corp.	1983-02-15	131

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