Calibrator, Primary

FDA product code JIS · Class II (moderate risk) · 21 CFR 862.1150 · Clinical Chemistry

130510(k) clearances
0PMA approvals
18recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K122126Direct Ldl/Hdl Cholesterol CalibratorJIS · Traditional Randox Laboratories Limited08/14/2012SE
K061251Dimension Vista Total Iron Binding Capacity CalibratorJIS · Traditional Dade Behring, Inc.05/31/2006SE
K060266Dimension Iron CalibratorJIS · Traditional Dade Behring, Inc.03/09/2006SE
K053104Dimension Cardiophase High Sensitivity C-Reactive Protein CalibratorJIS · Traditional Dade Behring, Inc.12/23/2005SE
K032697Dimension Total Triiodothyronine Calibrator (RC414)JIS · Traditional Dade Behring, Inc.11/07/2003SE
K032608Gonotec Calibration Solution 300 Mosmol/Kg for OsmometerJIS · Abbreviated Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB10/21/2003SE
K032296Vitros Immunodiagnostic Products Progestrone Reagent Pack and CalibratorsJIS · Special Ortho-Clinical Diagnostics, Inc.08/13/2003SE
K030964Calibration Plasma LMW HeparinJIS · Traditional Instrumentation Laboratory CO06/06/2003SE
K030546CRP (II) CalibratorsJIS · Traditional Denka Seiken Co., Ltd.06/02/2003SE
K030320Wako Autokit Micro Albumin, Wako Autokit Micro Calibrator Set, Micro Albumin Control SetJIS · Traditional Wako Chemicals USA, Inc.04/11/2003SE
K022682Randox C-Reactive Protein CalibratorJIS · Traditional Randox Laboratories, Ltd.11/05/2002SE
K022901Vitros Immunodiagnostic Products Progesterone Reagent Pack and CalibratorsJIS · Special Ortho-Clinical Diagnostics09/27/2002SE
K013126N Lp(A) Standard SyJIS · Traditional Dade Behring, Inc.11/09/2001SE
K012878Thermo Trace Ammonia Standards Set, Models TR-609JIS · Abbreviated Thermo Dma, Inc.10/16/2001SE
K011568Randox LipoproteinJIS · Traditional Randox Laboratories, Ltd.09/28/2001SE
K010696Beckman Coulter Dnase B CalibratorJIS · Traditional Beckman Coulter, Inc.05/10/2001SE
K003941Elecsys HCG Stat Claset IIJIS · Traditional Roche Diagnostics Corp.01/25/2001SE
K003969Elecsys Ca 125 II CalsetJIS · Special Roche Diagnostics Corp.01/12/2001SE
K002760Elecsys Dhea-S CalsetJIS · Traditional Roche Diagnostics Corp.10/05/2000SE
K002353Elecsys Ca 15-3 CalcheckJIS · Traditional Roche Diagnostics Corp.08/10/2000SE
K001906Elecsys Insulin CalsetJIS · Traditional Roche Diagnostics Corp.07/13/2000SE
K001005Wako Hdl-C/Ldl-C CalibratorJIS · Special Wako Chemicals USA, Inc.06/01/2000SE
K001004Wako Apolipoprotein High Level CalibratorJIS · Traditional Wako Chemicals USA, Inc.06/01/2000SE
K001002Wako Lipase CalibratorJIS · Traditional Wako Chemicals USA, Inc.05/24/2000SE
K000331Synchron LX Systems Microalbumin CalibratorJIS · Traditional Beckman Coulter, Inc.02/10/2000SE
K994169Synchron CX Systems Prealbumin CalibratorJIS · Traditional Beckman Coulter, Inc.02/03/2000SE
K994168Synchron LX Systems Prealbumin CalibratorJIS · Traditional Beckman Coulter, Inc.02/03/2000SE
K994114Dimension Total Iron Binding Capacity (Ibct) CalibratorJIS · Traditional Dade Behring, Inc.01/20/2000SE
K994325Synchron CX Systems Microalbumin CalibratorJIS · Traditional Beckman Coulter, Inc.01/12/2000SE
K994145Vitros Immunodiagnostic Products Free T3 Reagent Pack, Vitros Immunodiagnostic Products…JIS · Special Ortho-Clinical Diagnostics, Inc.12/22/1999SE
K993219Wako Bilirubin CalibratorJIS · Traditional Wako Chemicals USA, Inc.11/09/1999SE
K983640Synchron Systems Lipid CalibratorJIS · Traditional Beckman Coulter, Inc.12/21/1998SE
K970933Auto HDL Cholesterol CalibratorJIS · Traditional Pointe Scientific, Inc.,05/23/1997SE
K963847Wako Direct Hdl-CJIS · Traditional Wako Chemicals USA, Inc.12/24/1996SE
K964475Clinical Blood Gas MixturesJIS · Traditional Oxarc, Inc.12/06/1996SE
K954546Blood Gas MixtureJIS · Traditional Liquid Technology Corp.12/28/1995SE
K951964Synchron Enzyme Validator SetJIS · Traditional Beckman Instruments, Inc.06/29/1995SE
K951585T-Uptake CalibratorsJIS · Traditional Diagnostic Reagents, Inc.06/15/1995SE
K951629Imx EstradiolJIS · Traditional Abbott Laboratories05/17/1995SE
K944701CalibratorsJIS · Traditional Diagnostic Reagents, Inc.11/21/1994SE
K940008Glycated Protein CalibratorsJIS · Traditional Primus Corp.05/09/1994SE
K936201Urinary Albumin CalibratorJIS · Traditional Dupont Medical Products03/11/1994SE
K931834King Sodium/Potassium Standard ModifiedJIS · Traditional King Diagnostics, Inc.08/25/1993SE
K932555Dc-Lineate Cat. No. SE-091JIS · Traditional Diagnostic Chemicals, Ltd. (Usa)08/19/1993SE
K930501Du Pont Aca Nev/Eev VerifierJIS · Traditional Dupont Medical Products08/09/1993SE
K922646Reference Preparation for Proteins in Human SerumJIS · Traditional Behring Diagnostics, Inc.06/25/1993SE
K930477Acs Angiotensin Converting Enzyme (Ace) CalibratorJIS · Traditional Analytical Control Systems, Inc.06/07/1993SE
K925877Dc-Uibc-CalJIS · Traditional Diagnostic Chemicals, Ltd. (Usa)03/18/1993SE
K924904Hdl-Cholesterol Standard, ModificationJIS · Traditional Verichem Laboratories, Inc.01/13/1993SE
K922699Du Pont Aca Mass Creative Kinase MB (Mckmb) CalibrJIS · Traditional E.I. Dupont DE Nemours & Co., Inc.09/23/1992SE
K922698Du Pont Aca Plus Immunoassay System TSH CalibratorJIS · Traditional E.I. Dupont DE Nemours & Co., Inc.09/09/1992SE
K922696Du Pont Aca Plus Immunoasssay System HCG CalibratoJIS · Traditional E.I. Dupont DE Nemours & Co., Inc.08/12/1992SE
K921855Biotrol Bicarbonate StandardsJIS · Traditional Biotrol, USA, Inc.08/03/1992SE
K921903Thyroxine Calibrator KitJIS · Traditional Tudor Laboratories, Inc.05/26/1992SE
K920809King Diagnostics Sodium/Potassium StandardJIS · Traditional King Diagnostics, Inc.04/17/1992SE
K910721Biotrol Protein Multilevel StandardsJIS · Traditional Biotrol, USA, Inc.05/06/1991SE
K905820Aca(R) Lactic Dehydrogenase Isoenzyme 1(LD1) VeriJIS · Traditional E.I. Dupont DE Nemours & Co., Inc.02/26/1991SE
K905477Olympus Urine PH Calibrators Levels I and IIJIS · Traditional Em Diagnostic Systems, Inc.02/13/1991SE
K901113Matrix Plus(Tm) Chemistry Reference StandardJIS · Traditional Verichem Laboratories, Inc.03/29/1990SE
K895778Quantimetrix Bilirubin CalibratorsJIS · Traditional Quantimetrix Medical Industries11/14/1989SE
K895585Hi Chem Triglycerides Calibrator E (88185)JIS · Traditional Hichem Diagnostics11/13/1989SE
K884168Analyst Thyroxine (T4) & Thyronine Uptake Calibra.JIS · Traditional The DU Pont Co.11/29/1988SE
K882726Raichem(Tm) Bilirubin StandardJIS · Traditional Reagents Applications, Inc.08/29/1988SE
K881693Terumo Sensibead Eia Progesterone KitJIS · Traditional Terumo Medical Corp.06/07/1988SE
K872051Calcium CalibratorJIS · Traditional Wako Chemicals USA, Inc.09/18/1987SE
K871188Lithium Internal Standard 1500 Meq/L #60086JIS · Traditional In Vitro Diagnostics, Inc.05/28/1987SE
K871187Lithium Internal Standard 3000 Meq/L #60084JIS · Traditional In Vitro Diagnostics, Inc.05/28/1987SE
K871186Cesium Diluent 1.5 Mmol Cs/L #60087JIS · Traditional In Vitro Diagnostics, Inc.05/28/1987SE
K871185Lithium Internal Standard 1 Meq/L #60085JIS · Traditional In Vitro Diagnostics, Inc.05/28/1987SE
K870379Ise Compensation SeraJIS · Traditional Boehringer Mannheim Corp.02/26/1987SE
K862704Emds(Tm) Elevated Bilirubin Calibrator # 67627/95JIS · Traditional Em Diagnostic Systems, Inc.08/19/1986SE
K862453Emds Theophylline Calibrators Item No. 67---/93JIS · Traditional Em Diagnostic Systems, Inc.08/19/1986SE
K861891Tobramycin (Fpia) Calibrator KitJIS · Traditional Windsor Laboratories, Inc.06/25/1986SE
K861770Phenytoin (Fpia) Calibrator KitJIS · Traditional Windsor Laboratories, Inc.06/25/1986SE
K861769Gentamicin (Fpia) Calibrator KitJIS · Traditional Windsor Laboratories, Inc.06/25/1986SE
K861768Theophylline (Fpia) Calibrator KitJIS · Traditional Windsor Laboratories, Inc.06/25/1986SE
K855040Seralyzer Total Bilirubin CalibratorsJIS · Traditional Miles Laboratories, Inc.01/22/1986SE
K852068Total Bilirubin StandardsJIS · Traditional Data Medical Associates, Inc.05/31/1985SE
K84458180 Mg/Dl Glucose ControlJIS · Traditional Boehringer Mannheim Corp.12/12/1984SE
K844235Chloride StandardJIS · Traditional Shaban Mfg. Co.11/20/1984SE
K843110Roche Standards for CholesterolJIS · Traditional Roche Diagnostic Systems, Inc.09/04/1984SE
K842450Hichem Ion 2/4 Urine Range CalibratorJIS · Traditional Hi Chem, Inc.08/16/1984SE
K842449Hichem Ion 2/4 Serum Range CalibratorJIS · Traditional Hi Chem, Inc.08/16/1984SE
K841955Dupont Aca Magnesium CalibratorJIS · Traditional E.I. Dupont DE Nemours & Co., Inc.06/25/1984SE
K840299PH Electrode Calibrating Buffers-BloodJIS · Traditional Bionostics, Inc.03/23/1984SE
K840220HDL Cholesterol Aqueous StandardsJIS · Traditional Preventive Diagnostics Corp.03/23/1984SE
K840217Cholesterol Aqueous StandardJIS · Traditional Preventive Diagnostics Corp.03/23/1984SE
K832251Preciset Cholesterol High PerformJIS · Traditional Boehringer Mannheim Corp.08/24/1983SE
K830283Lithium DiluentJIS · Traditional Shaban Mfg. Co.02/28/1983SE
K830137Calibrator aJIS · Traditional Hi Chem, Inc.02/07/1983SE
K823147Uric Acid Standard, 8MG/DL #65078JIS · Traditional Harleco Diagnostics11/22/1982SE
K822477Creatinine Standard #65072JIS · Traditional Emd Chemicals, Inc.09/17/1982SE
K822473Calcium Standard, Item #65075JIS · Traditional Emd Chemicals, Inc.09/17/1982SE
K822476Phosphorous Standard #65073JIS · Traditional Emd Chemicals, Inc.09/14/1982SE
K822474Cholesterol Standard #65077JIS · Traditional Emd Chemicals, Inc.09/14/1982SE
K822332C-Reactive Protein Test KitJIS · Traditional Sclavo, Inc.08/16/1982SE
K822232Aca Urinary Protein CalibratorJIS · Traditional E.I. Dupont DE Nemours & Co., Inc.08/16/1982SE
K821934Bio-Cal Operation Check KitJIS · Traditional Bio-Analytics Laboratories, Inc.07/20/1982SE
K821938Syva Advance Standardization Kit #3JIS · Traditional Syva Co.07/16/1982SE
K821937Syva Advance Standardization Kit #2JIS · Traditional Syva Co.07/16/1982SE
K821813Beckman Uric Acid StandardJIS · Traditional Beckman Instruments, Inc.07/02/1982SE
K821061Ace Albumin CalibratorJIS · Traditional E.I. Dupont DE Nemours & Co., Inc.05/03/1982SE
K820698Syva Advance Standardization Kit 01JIS · Traditional Syva Co.04/01/1982SE
K813505Flame Photometer Calibration StandardsJIS · Traditional Fisher Scientific Co., LLC12/31/1981SE
K813447Solutions & Buffers for Blood Gas InstrJIS · Traditional Rna Medical Corp.12/31/1981SE
K813478Triglyceride CalibratorsJIS · Traditional Gilford Diagnostics12/22/1981SE
K812861Cholesterol CalibratorsJIS · Traditional Gilford Diagnostics10/23/1981SE
K810963Bio Set TM Substrate CalibratorsJIS · Traditional Boehringer Mannheim Corp.04/17/1981SE
K810867Follicle Stimulating Hormone (FSH)JIS · Traditional Pcl-Ria, Inc.04/14/1981SE
K810743Lecithin-Spingomyelin Stand. & KitsJIS · Traditional Supelco, Inc.03/31/1981SE
K810742Aqueous Triolein Standards & KitsJIS · Traditional Supelco, Inc.03/31/1981SE
K810618Ampuled Flame Photometer StandardsJIS · Traditional United Diagnostics, Inc.03/31/1981SE
K810587Emit-Tfg Prisma Thyroxine CalibratorsJIS · Traditional Syva Co.03/24/1981SE
K810092Cholesterol StandardJIS · Traditional Anco Medical Reagents & Assoc.02/02/1981SE
K810091Glucose StandardJIS · Traditional Anco Medical Reagents & Assoc.01/26/1981SE
K802631Creatinine StandardsJIS · Traditional Gilford Diagnostics12/11/1980SE
K801501UV Uric Acid StandardsJIS · Traditional The Dow Chemical Co.09/26/1980SE
K801665Seralyzer Glucose Calibrators(Low&High)JIS · Traditional Miles Laboratories, Inc.08/20/1980SE
K801287Emit Aaii Thyroxine CalibratorsJIS · Traditional Syva Co.06/30/1980SE
K800588Nsi Calibrator SetJIS · Traditional Nobel Scientific Industries, Inc.04/04/1980SE
K800206Aca Choleserol/Hdl Cholesterol Calibrat.JIS · Traditional E.I. Dupont DE Nemours & Co., Inc.03/03/1980SE
K800062Pipet Calibration KitJIS · Traditional Streck Laboratories, Inc.02/11/1980SE
K800042Lithium Standard (1MM/L)JIS · Traditional Gilford Diagnostics01/21/1980SE
K792046Uric Acid StandardJIS · Traditional Gilford Diagnostics10/30/1979SE
K791315Spectro-Sur SetJIS · Traditional Helena Laboratories08/16/1979SE
K781853Cholesterol StandardsJIS · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic12/04/1978SE
K780467Emit Antiepileptic Drug CalibratorsJIS · Traditional Syva Co.04/24/1978SE
K772025Uric Acid Std. for Quant. Uric AcidJIS · Traditional Worthington Biochemical Corp.11/11/1977SE
K770072Bio Trol-T Triolein SolutionsJIS · Traditional Boehringer Mannheim Corp.01/26/1977SE
K760806Referee Aqueous Triglyceride STNDJIS · Traditional Analytical Products, Inc.10/21/1976SE

Recalls

RecallProductFirmInitiated
Z-1822-2025 Class IIADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay… Siemens Healthcare Diagnostics, Inc.04/15/2025Open, Classified
Z-1821-2025 Class IIAtellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay… Siemens Healthcare Diagnostics, Inc.04/15/2025Open, Classified
Z-1819-2024 Class IIVITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3…Free T3 Calibrators used with T3 Reagent Packs may produce positively biased results for patient and quality… Quidelortho04/09/2024Open, Classified
Z-0891-2022 Class IIARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin…This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is… Abbott Laboratories03/08/2022Open, Classified
Z-0033-2022 Class IIIAlinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product…Calibrator vials were incorrectly labeled. Use of incorrectly labeled vials will cause the instrument to… Sentinel CH SpA07/29/2021Terminated
Z-0932-2021 Class IIIWako HDL-C/LDL-C Calibrator - Product Usage: designed to be used with Wako L-Type HDL-C…FUJIFILM has become aware that incorrect concentration values were printed on the bottle label for all… Fujifilm Medical Systems U.S.A., Inc.12/22/2020Terminated
Z-0844-2019 Class IIVitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration of the…A stability issue in the calibrators may cause calibration failures or atypical Quality Control results… Ortho Clinical Diagnostics Inc11/29/2018Terminated
Z-1712-2017 Class IIIADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays…Siemens Healthcare Diagnostics has confirmed a positive bias of up to 41% in quality control and patient… Siemens Healthcare Diagnostics, Inc.02/23/2017Terminated
Z-0407-2017 Class IIAccess Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase…Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their… Beckman Coulter Inc.10/24/2016Terminated
Z-1970-2013 Class IIIADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN…Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay. Siemens Healthcare Diagnostics, Inc06/28/2013Terminated
Z-1122-2013 Class IIADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the…Negative bias in patient samples for Vitamin D Siemens Healthcare Diagnostics, Inc03/13/2013Terminated
Z-1121-2013 Class IIADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the…Negative bias in patient samples for Vitamin D Siemens Healthcare Diagnostics, Inc03/13/2013Terminated
Z-0745-2013 Class IIIDimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R)…Siemens Healthcare Diagnostics has received complaints of IRON calibrations outside of acceptable… Siemens Healthcare Diagnostics, Inc.12/20/2012Terminated
Z-0613-2013 Class IIAccess Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4…A recall communication was initiated because Beckman has identified that Access Total T4 calibrator lots… Beckman Coulter Inc.07/27/2011Terminated
Z-2605-2011 Access Immunoassay Systems Ostase Calibrators, Part Number: 37305 The Access Ostase…The recall was initiated because Beckman Coulter has confirmed that Access Ostase Calibrator and QC vials… Beckman Coulter Inc.05/10/2011Terminated
Z-1566-2008 AxSYM Ultrasensitive hTSH II Master Calibrators Microparticle Enzyme Immunoassay that…High Control value out of range after calibration. --AN INCREASED FREQUENCY OF HIGH CONTROL VALUES BEYOND… Abbott Diagnostic International, Ltd.03/06/2008Terminated
Z-0023-2007 Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators… Abbott Diagnostic International, Ltd.09/07/2006Terminated
Z-0082-2007 TOSOH AIA-PACK FOLATE Calibrator Sets, six levels, Catalog Number-020392. The…Reports of low calibration rate value flags; Use of the recalled product may result in failure to calibrate… Tosoh Bioscience Inc09/01/2006Terminated