Product code JJX

Device name: Single (Specified) Analyte Controls (Assayed And Unassayed)
Medical specialty: Clinical Chemistry
Device class: 1
Regulation number: 862.1660
Review panel: CH
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K170678	Beta-CrossLaps CalCheck 5	Roche Diagnostics	2017-04-04
K162173	Elecsys CYFRA 21-1 CalCheck 5	Roche Diagnostics	2017-01-12
K162514	Multichem A1c	Technopath Manufacturing	2016-10-26
K161874	Audit MicroControls Linearity DROP LQ Blood Glucose	Aalto Scientific, Ltd.	2016-08-10
K161526	LIAISON CMV IgM Serum Control Set	DiaSorin, Inc.	2016-06-30
K161522	LIAISON EBV IgM Serum Control Set	DiaSorin, Inc.	2016-06-30
K161082	IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers	Immunodiagnostic Systems , Ltd.	2016-05-17
K152117	Dropper hsCRP High Sensitivity CRP Control	Quantimetrix Corporation	2016-04-21
K151742	Contour Next Control Solution	Bayer Healthcare	2015-09-23
K143687	ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material	Siemens Healthcare Diagnostics, Inc.	2015-07-17
K150955	Elecsys Progesterone III Cal Check 5	Roche Diagnostics	2015-05-01
K150132	IMMULITE IGF Control Module, IMMULITE Gastrin Control Module	Siemens Healthcare Diagnostics	2015-04-13
K143324	IDS-iSYS CTX-I Calibration Verifiers	Immunodiagnostic Systems , Ltd.	2015-03-30
K143373	IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material	Siemens Healthcare Diagnostics, Inc.	2015-02-26
K143636	IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material	Siemens Healthcare Diagnostics, Inc.	2015-02-25
K143680	ADVIA Centaur IgE Master Curve Material	Siemens Healthcare Diagnostics, Inc.	2015-01-27
K143639	IMMULITE 2000 CEA Calibration Verification Material	Siemens Healthcare Diagnostics	2015-01-23
K143571	Audit MicroControls Linearity LQ Cystatin-C	Aalto Scientific, Ltd.	2015-01-23
K143504	IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material	Siemens Healthcare Diagnostics, Inc.	2015-01-14
K143352	IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material	Siemens Healthcare Diagnostics, Inc.	2014-12-24
K143376	ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material	Siemens Healthcare Diagnostics, Inc.	2014-12-23
K143296	AIA-PACK C-Peptide Control Set	Tosoh Bioscience, Inc.	2014-12-16
K143284	Elecsys Estradiol III Calcheck	Roche Diagnostics	2014-12-16
K143194	ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM)	Siemens Healthcare Diagnostics, Inc.	2014-12-05
K143026	Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity	Aalto Scientific, Ltd.	2014-11-21
K142878	IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material	Siemens Healthcare Diagnostics, Inc.	2014-10-30
K142864	ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM)	Siemens Healthcare Diagnostics, Inc.	2014-10-29
K142811	IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM)	Siemens Healthcare Diagnostics, Inc.	2014-10-29
K142127	ELECSYS ESTRADIOL III CALCHECK 5	Roche Diagnostics	2014-09-05
K141772	IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL	Siemens Healthcare Diagnostics, Inc.	2014-08-19

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00850011135877	VALIDATE	Lgc Clinical Diagnostics, Inc.	2026-06-05
00850011135891	VALIDATE	Lgc Clinical Diagnostics, Inc.	2026-06-02
00630414608273	ADVIA Centaur Tumor Marker Quality Control (TM QC)	Siemens Healthcare Diagnostics Inc.	2026-05-29
00630414622859	Atellica IM Tumor Marker Quality Control (TM QC)	Siemens Healthcare Diagnostics Inc.	2026-05-29
07613336234457	PreciControl Syphilis	Roche Diagnostics GmbH	2026-05-15
08058056685407	Cystatin C Controls	SENTINEL CH. SPA	2025-09-16
00380740153762	Alinity	ABBOTT LABORATORIES	2023-10-14
07613336166338	PreciControl beta-Amyloid (1-42) II	Roche Diagnostics GmbH	2022-12-13
07613336180860	CalCheck beta-Amyloid (1-42) II	Roche Diagnostics GmbH	2022-12-13
08426950597056	QUANTA Flash® SS-B Controls	INOVA DIAGNOSTICS, INC.	2017-08-28
08426950597353	QUANTA Flash® β2GPI IgA Controls	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950597063	QUANTA Flash® Ro60 Controls	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950596660	QUANTA Flash® Ro52 Controls	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950596097	QUANTA Flash® Centromere Controls	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950596073	QUANTA Flash® RNP Controls	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950596035	QUANTA Flash® Sm Controls	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950596011	QUANTA Flash® Jo-1 Controls	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950595847	QUANTA Flash® DGP Screen Controls	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950595250	QUANTA Flash® β2GPI IgG Controls	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950595038	QUANTA Flash® β2GPI IgM Controls	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950594994	QUANTA Flash® aCL IgM Controls	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950594888	QUANTA Flash® GBM Controls	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950594765	QUANTA Flash® h-tTG IgG Controls	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950594413	QUANTA Flash® DGP IgG Controls	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950557579	QUANTA Flash® DGP IgA Controls	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950554561	QUANTA Flash® MPO Controls	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950554554	QUANTA Flash® PR3 Controls	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950554493	QUANTA Flash® h-tTG IgA Controls	INOVA DIAGNOSTICS, INC.	2016-08-31
08426950554486	QUANTA Flash® aCL IgG Controls	INOVA DIAGNOSTICS, INC.	2016-08-31
08058056681775	ACE Control Set	SENTINEL CH. SPA	2016-07-29

Product code JJX

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