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

LTJ — Predicate Candidate Screening

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

90 daysmedian FDA review time

266 days90th percentile

34clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K251630	Atellica IM Total PSA II (tPSAII)	Siemens Healthcare Diagnostics, Inc.	2026-01-05	222	0
K162378	FREND PSA PLUS (reagent cartridge)	Nanoentek USA, Inc.	2017-05-17	266	0
K124056	FREND PSA PLUS (REAGENT CARTRIDGE)	Nanoentek, Inc.	2013-05-29	149	0
K031343	TPSA FLEX REAGENT CARTRIDGE	Dade Behring, Inc.	2003-05-15	16	0
K022177	PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRAT	Bayer Diagnostics Corp.	2002-12-17	167	0
K022288	COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAY	Bayer Corp.	2002-12-17	155	0
K010550	VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428	bioMerieux, Inc.	2001-04-24	57	0
K003963	DIMENSION PSA FLEX REAGENT CARTRIDGE	Dade Behring, Inc.	2001-02-28	68	0
K002376	ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY	Bayer Corp.	2000-10-26	83	0
K003094	FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER	Qualigen, Inc.	2000-10-25	22	0
K002121	TOTAL PSA MICROTITER ELISA	Oncogene Science, Inc.	2000-08-30	48	0
K002313	COMPLEXED PSA MICROTITER ELISA	Oncogene Science, Inc.	2000-08-30	30	0
K994419	FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM	Qualisys Diagnostics, Inc.	2000-06-28	182	2
K994221	BAYER PSA ASSAY	Bayer Corp.	2000-04-13	120	0
K000566	MODOFICATION TO VITRO IMMUNODIAGNOSTIC PRODUCTS PSA REAGENT	Ortho-Clinical Diagnostics, Inc.	2000-03-09	16	0
K990234	QUALISYS PSA IMMUNOASSAY	Qualisys Diagnostics, Inc.	1999-07-08	164	0
K984289	VITROS IMMUNODIAGNOSTIC PRODUCTS PSA CALIBRATORS, VITROS IMM	Ortho-Clinical Diagnostics, Inc.	1999-03-12	101	0
K982949	ELECSYS PSA, MODEL 2010	Boehringer Mannheim Corp.	1998-10-27	67	0
K982948	ELECSYS PSA, MODEL # ELECSYS 1010	Boehringer Mannheim Corp.	1998-10-27	67	0
K981634	BIOCIRCUITS IOS PROSTATE SPECIFIC ANTIGEN (PSA) TEST CARTRID	Biocircuits Corp.	1998-10-13	158	0
K981839	ACS:CENTAUR PSA2 IMMUNOASSAY	Chiron Diagnostics Corp.	1998-08-12	78	0
K973243	ACTIVE PSA ELISA (DSL-10-9700)	Diagnostic Systems Laboratories, Inc.	1998-08-03	339	0
K973244	ACTIVE PSA IRMA (DSL-9700)	Diagnostic Systems Laboratories, Inc.	1998-08-03	339	0
K980376	THE COMPLEXED PSA ASSAY FOR THE BAYER IMMUNO 1 SYSTEM	Bayer Corp.	1998-04-23	83	0
K974842	IMMULITE 2000 3RD GENERATION PSA	Diagnostic Products Corp.	1998-04-21	118	0
K980716	ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA)	Nichols Institute Diagnostics	1998-04-03	86	0
K974816	ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER	Beckman Instruments, Inc.	1998-02-20	59	0
K974189	ELECSYS PSA (ON ELECSYS 1010)	Boehringer Mannheim Corp.	1998-01-06	60	0
K972021	IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5)	Diagnostic Products Corp.	1997-10-31	151	0
K973101	PROSTATE SPECIFIC ANTIGEN METHOD	Dade Chemistry Systems, Inc.	1997-09-18	30	0
K972095	IMMULITE 2000 PSA	Diagnostic Products Corp.	1997-08-22	79	0
K964351	ELECSYS PSA ASSAY	Boehringer Mannheim Corp.	1997-07-25	266	0
K964595	OPUS PSA TEST SYSTEM	Behring Diagnostics, Inc.	1997-06-24	218	0
K965085	ENZYMUN-TEST PSA	Boehringer Mannheim Corp.	1997-03-19	90	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