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

JJX — Predicate Candidate Screening

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

43 daysmedian FDA review time

132 days90th percentile

493clearances measured

K-number	Device	Applicant	Decided	Review days
K170678	Beta-CrossLaps CalCheck 5	Roche Diagnostics	2017-04-04	29
K162173	Elecsys CYFRA 21-1 CalCheck 5	Roche Diagnostics	2017-01-12	162
K162514	Multichem A1c	Technopath Manufacturing	2016-10-26	48
K161874	Audit MicroControls Linearity DROP LQ Blood Glucose	Aalto Scientific, Ltd.	2016-08-10	33
K161522	LIAISON EBV IgM Serum Control Set	DiaSorin, Inc.	2016-06-30	28
K161526	LIAISON CMV IgM Serum Control Set	DiaSorin, Inc.	2016-06-30	28
K161082	IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Prog	Immunodiagnostic Systems , Ltd.	2016-05-17	29
K152117	Dropper hsCRP High Sensitivity CRP Control	Quantimetrix Corporation	2016-04-21	266
K151742	Contour Next Control Solution	Bayer Healthcare	2015-09-23	86
K143687	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curv	Siemens Healthcare Diagnostics, Inc.	2015-07-17	205
K150955	Elecsys Progesterone III Cal Check 5	Roche Diagnostics	2015-05-01	22
K150132	IMMULITE IGF Control Module, IMMULITE Gastrin Control Module	Siemens Healthcare Diagnostics	2015-04-13	82
K143324	IDS-iSYS CTX-I Calibration Verifiers	Immunodiagnostic Systems , Ltd.	2015-03-30	131
K143373	IMMULITE® 2000 Calcitonin Calibration Verification Material	Siemens Healthcare Diagnostics, Inc.	2015-02-26	93
K143636	IMMULITE 2000 Androstenedione Calibration Verification Mater	Siemens Healthcare Diagnostics, Inc.	2015-02-25	65
K143680	ADVIA Centaur IgE Master Curve Material	Siemens Healthcare Diagnostics, Inc.	2015-01-27	34
K143639	IMMULITE 2000 CEA Calibration Verification Material	Siemens Healthcare Diagnostics	2015-01-23	32
K143571	Audit MicroControls Linearity LQ Cystatin-C	Aalto Scientific, Ltd.	2015-01-23	37
K143504	IMMULITE 2000 Albumin Calibration Verification Material, IMM	Siemens Healthcare Diagnostics, Inc.	2015-01-14	35
K143352	IMMULITE 2000 Ferritin Calibration Verification Material, IM	Siemens Healthcare Diagnostics, Inc.	2014-12-24	30
K143376	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIV	Siemens Healthcare Diagnostics, Inc.	2014-12-23	28
K143284	Elecsys Estradiol III Calcheck	Roche Diagnostics	2014-12-16	29
K143296	AIA-PACK C-Peptide Control Set	Tosoh Bioscience, Inc.	2014-12-16	29
K143194	ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA C	Siemens Healthcare Diagnostics, Inc.	2014-12-05	29
K143026	Audit MicroControls Linearity FD Unsaturated Iron Binding Ca	Aalto Scientific, Ltd.	2014-11-21	31
K142878	IMMULITE 2000 Beta-2 Microglobulin Calibration Verification	Siemens Healthcare Diagnostics, Inc.	2014-10-30	28
K142864	ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), A	Siemens Healthcare Diagnostics, Inc.	2014-10-29	28
K142811	IMMULITE 2000 LH Calibration Verification Material (CVM), IM	Siemens Healthcare Diagnostics, Inc.	2014-10-29	30
K142127	ELECSYS ESTRADIOL III CALCHECK 5	Roche Diagnostics	2014-09-05	32
K141772	IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATI	Siemens Healthcare Diagnostics, Inc.	2014-08-19	49
K141444	IMMULITE 2000; CORTISOL CALIBRATION VERIFICATION MATERIAL, F	Siemens Healthcare Diagnostics, Inc.	2014-07-09	37
K133816	IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL	Siemens Healthcare Diagnostics, Inc.	2014-06-24	190
K140818	IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 20	Siemens Healthcare Diagnostics, Inc.	2014-05-01	30
K140541	IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL,	Siemens Healthcare Diagnostics, Inc.	2014-04-01	28
K140505	ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG M	Siemens Healthcare Diagnostics, Inc.	2014-03-31	32
K140534	ELECSYS PRECICONTROL TS	Roche Diagnostics	2014-03-27	23
K140267	ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA C	Siemens Healthcare Diagnostics, Inc.	2014-03-10	35
K140258	IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH	Siemens Healthcare Diagnostics, Inc.	2014-03-05	30
K133550	VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST K	Maine Standards Company, LLC	2014-02-05	78
K133197	FDI LEVEL I AND LEVEL II GLUCOSE CONTROLS FOR THE EMBRACE NO	Fujirebio Diagnostics,Inc.	2014-01-17	92
K132739	IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION	Siemens Healthcare Diagnostics, Inc.	2014-01-14	133
K133284	ELECSYS CK-MB CALCHECK 5	Roche Diagnostics	2013-11-22	28
K133122	IMMULITE 2000; 3GALLERGY SPECIFIC IGE CONTROL VERIFICATION M	Siemens Healthcare Diagnostics, Inc.	2013-10-30	30
K133124	IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, T	Siemens Healthcare Diagnostics, Inc.	2013-10-25	25
K133003	RIGHTEST CONTROL SOLUTION	Bionime Corporation	2013-10-24	29
K133128	IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULI	Siemens Healthcare Diagnostics, Inc.	2013-10-22	22
K131662	IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL	Siemens Healthcare Diagnostics, Inc.	2013-10-10	125
K132391	IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL,	Siemens Helathcare Diagnostics, Inc.	2013-09-20	50
K131536	IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL	Siemens Healthcare Diagnostics, Inc.	2013-08-12	75
K131999	HBA1C CONTROL, LEVEL 1 AND LEVEL 2	Randox Laboratories, Ltd.	2013-07-26	28

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