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

JIX — Predicate Candidate Screening

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

49 daysmedian FDA review time

122 days90th percentile

302clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K161140	VITROS Chemistry Products Calibrator Kit 3	Ortho-Clinical Diagnostics, Inc.	2016-05-20	28	0
K153365	ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme	Siemens Healthcare Diagnostics, Inc.	2015-12-18	28	0
K151552	ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems	Elitechgroup	2015-07-08	29	0
K140790	Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimensi	Siemens Healthcare Diagnostics	2015-06-15	441	1
K141388	SYSTEM CALIBRATER	Beckman Coulter Ireland, Inc.	2014-07-11	45	0
K133330	C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI	Roche Diagnostics	2013-11-26	25	0
K130765	ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS	Elitechgroup	2013-04-04	15	0
K123321	DIMENSION CHEMISTRY III CALIBRATORY	Siemens Healthcare Diagnostics	2013-02-15	112	0
K123372	ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR	Abbott Laboratories	2013-01-14	74	0
K122398	RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS	Siemens Healthcare Diagnostics, Inc.	2012-10-12	66	4
K112834	MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE	Verichem Laboratories, Inc.	2012-03-28	182	0
K112029	ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS	Elitechgroup	2011-08-30	46	0
K110394	ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)	Vital Diagnostics (Manufacturing) Ptyltd	2011-06-09	118	0
K110251	SYNCHRON MULTI CALIBRATOR	Beckman Coulter, Inc.	2011-05-25	117	1
K103701	ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS	Siemens Healthcare Diagnostics, Inc.	2011-02-18	60	0
K103171	ELECSYS ANTI-TPO CALSET	Roche Diagnostics	2011-02-11	107	0
K103403	MULTICONSTITUENT CALIBRATOR	Abbott Laboratories	2011-02-04	77	0
K103612	DIMENSION VISA ENZ 2 CAL	Siemens Healthcare Diagnostics, Inc.	2011-01-25	47	0
K101456	ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DI	Roche Diagnostics	2010-09-08	105	0
K101460	LOCI 8 CALIBRATOR, MODEL KC 646	Siemens Healthcare Diagnostics	2010-07-09	44	1
K100778	DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A	Siemens Healthcare Diagnostics	2010-05-05	47	0
K093732	ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770	Siemens Healthcare Diagnostics	2010-03-22	108	1
K093645	EXL ANEM CAL, MODEL RC640	Siemens Healthcare Diagnostics	2010-03-05	100	0
K092113	STA - FREE PS CALIBRATOR	Diagnostica Stago, Inc.	2009-11-13	122	0
K090283	CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CA	Genchem, Inc.	2009-06-05	120	0
K080404	EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTE	Medica Corp.	2009-03-13	393	0
K083579	DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360	Siemens Healthcare Diagnostics	2009-02-20	78	0
K081533	SENTINEL PLASMAPROTEINS CAL 3X	SENTINEL CH. SpA	2008-06-25	23	0
K081103	LOCI THYROID CALIBRATOR WITH MODEL RC610	Siemens Healthcare Diagnostics, Inc.	2008-05-23	35	0
K073612	URIC ACID (AOX), SCAL, NORTROL, ABTROL	Thermofisher Scientific OY	2008-05-23	154	0
K080607	CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MO	Roche Diagnostics Corp.	2008-05-12	69	0
K071779	ABX PENTRA URINE CAL	Horiba Abx	2008-03-05	247	0
K072435	DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L,	Dade Behring, Inc.	2007-10-17	48	0
K072204	ADVIA CHEMISTRY MICROALBUMIN CALIBRATORS, _2 CALIBRATORS	Siemens Medical Solutions Diagnostics	2007-10-05	58	0
K071801	VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL	Ortho-Clinical Diagnostics, Inc.	2007-07-20	18	0
K070971	MODIFICATION TO SENTINEL CLIN CHEM CAL	Sentinel Ch. Srl	2007-05-23	47	0
K070207	MULTI-ANALYTE CHEMISTRY CALIBRATOR	Pointe Scientific, Inc.,	2007-04-13	81	0
K063508	DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PR	Dade Behring, Inc.	2007-01-23	64	0
K062035	DIMENSION VISTA RF FLEX REAGENT CARTRIDGE; PROTEIN 2 CALIBRA	Dade Behring, Inc.	2006-10-04	77	0
K062334	DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130	Dade Behring, Inc.	2006-09-22	43	1
K062319	CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350	Roche Diagnostics Corp.	2006-09-13	35	0
K062034	DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410	Dade Behring, Inc.	2006-09-06	49	0
K062122	DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL -	Dade Behring, Inc.	2006-08-25	31	0
K061923	DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)	Dade Behring, Inc.	2006-08-25	49	1
K061838	DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110	Dade Behring, Inc.	2006-08-21	53	2
K061750	DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220	Dade Behring, Inc.	2006-08-11	51	0
K062055	DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL M	Dade Behring, Inc.	2006-08-07	18	0
K061703	DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)	Dade Behring, Inc.	2006-08-02	47	1
K061056	RANDOX LIQUID PROTEIN CALIBRATOR	Randox Laboratories, Ltd.	2006-07-20	94	2
K061390	DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320	Dade Behring, Inc.	2006-07-05	48	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