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

GTJ — Predicate Candidate Screening

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

73 daysmedian FDA review time

295 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K952791	DIRECTIGEN MENINGITIS COMBO TEST	Bd Becton Dickinson Vacutainer Systems Preanalytic	1996-05-30	346	0
K915330	DIRECTIGEN MENINGITIS COMBO TEST KIT	Bd Becton Dickinson Vacutainer Systems Preanalytic	1992-03-23	118	0
K910210	SLIDEX MENINGITE-KIT 5	Vitek Systems, Inc.	1991-08-12	209	0
K885004	BACTIGEN(R) N. MENINGITIDIS	Armkel, LLC	1989-02-07	68	0
K870089	IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT	Microscan Div. Baxter Healthcare Corp.	1987-03-17	67	0
K854851	WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24	Wellcome Diagnostics	1986-02-04	61	0
K854852	WELLCOGEN BACTERIAL ANTIGEN KIT	Wellcome Diagnostics	1986-02-04	61	0
K844999	PHADEBACT CSF TEST	Pharmacia, Inc.	1985-10-17	295	0
K851691	WILLCOGEN MENINGITIDIS KIT ZL25	Wellcome Diagnostics	1985-06-10	48	0
K844762	MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51	Wellcome Diagnostics	1985-06-04	179	0
K844407	DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST	Bd Becton Dickinson Vacutainer Systems Preanalytic	1985-01-25	73	4
K841907	BACTIGEN - N.MENNINIGITIDIS TEST	Armkel, LLC	1984-07-06	59	0
K833063	WELLCOGEN N. MENINGITIDIS A,C,Y W135	Wellcome Diagnostics	1984-01-10	123	0
K823880	BACTIGEN-N. MENINGITIDIS	Armkel, LLC	1983-03-09	72	0
K822810	PHADEBACT CSF TEST 20	Pharmacia, Inc.	1982-12-30	101	0
K771562	AGGLUTINATING SERUM W135	Burroughs Wellcome Co.	1977-08-25	10	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