Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

GQI — Predicate Candidate Screening

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

185 daysmedian FDA review time

514 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K952254	ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS	Pyramid Biological Corp.	1995-11-16	185
K951800	CMV IGG HUMAN SERUM CONTROLS	Pyramid Biological Corp.	1995-11-16	212
K942171	CMV EARLY ANTIGEN TEST	Neogenex	1994-06-30	56
K883102	VIRGO (R) CMV-IGG ELISA	Electro-Nucleonics, Inc.	1989-02-08	201
K875159	DETECTADOT SYSTEM 2000 CMV IGG TEST	Gull Laboratories, Inc.	1988-05-06	142
K863488	ENZYGNOST ANTI-CMV IGG TEST	Behring Diagnostics, Inc.	1987-07-20	314
K864420	CMV MICROASSAY	Diamedix Corp.	1987-02-02	84
K861123	THE GOLDEN QUAD TEST (CMV)	Microbiological Research Corp.	1987-02-02	314
K862705	CYTOMEGALOVIRUS IGG EIA TEST KIT	Labsystems, Inc.	1986-10-01	77
K853989	COR DOT CMV	Cordis Corp.	1986-06-13	259
K860493	CYTOTECH CMV IGG EIA	Cytotech, Inc.	1986-05-20	99
K854666	CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530	Clinical Sciences, Inc.	1986-02-05	76
K843189	CYTOMEGALOVIRUS IGG EIA TEST KIT	Labsystems, Inc.	1986-01-08	513
K842661	ANTI-CYTOMEGALOVIRUS KIT	Amico Lab, Inc.	1985-12-06	514
K842529	AMIZYME-CMV KIT	Amico Lab, Inc.	1985-12-06	526
K853137	CMV TEST	Gull Laboratories, Inc.	1985-11-14	111
K852929	CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR	Microbix Biosystems, Inc.	1985-11-12	126
K853277	CMV CF ANTIGEN	Hillcrest Biologicals	1985-11-07	94

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