Atlas FDA

JIT

245 FDA 510(k) clearances · Product code

41 daysmedian time to decision
133 days90th percentile
245clearances measured

FDA profile

Official device name
Calibrator, Secondary
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1150
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2012: 10 · 2013: 43 · 2014: 9 · 2019: 215 · 2020: 12 · 2024: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
VITROS Immunodiagnostic Products Insulin Calibrators (K171168)Ortho Clinical Diagnostics2017-05-16
CalSet IGF-1 (K170938)Roche Diagnostics2017-04-26
Abbott ARCHITECT Free T3 (K170160)Abbott Laboratories2017-02-15
Lumipulse G FSH-N Calibrators (K163534)Fujirebio Diagnostics,Inc.2017-01-13
Lumipulse G Progesterone-N Calibrators (K163546)Fujirebio Diagnostics,Inc.2017-01-13
Lumipulse G Prolactin (K163544)Fujirebio Diagnostics,Inc.2017-01-12
Lumipulse G LH Calibrators (K163521)Fujirebio Diagnostics,Inc.2017-01-12
DC-UIBC-CAL (K163078)Sekisui Diagnostics P.E.I., Inc.2016-12-08
Lumipulse G E2-III Calibrators (K163053)Fujirebio Diagnostics,Inc.2016-12-01
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator (K162538)Siemens Healthcare Diagnostics2016-11-17
ST AIA-PACK hsE2 Calibrator Set (K160113)Tosoh Bioscience, Inc.2016-02-17
ST AIA-PACK PROG III Calibrator Set (K153417)Tosoh Bioscience, Inc.2015-12-18
Elecsys Progesterone III CalSet (K152526)Roche Diagnostics2015-10-02
Abbott ARCHITECT Total T4 Calibrators (K151566)Abbott Laboratories2015-07-10
UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator (K142985)Beckman Coulter, Inc.2015-02-26
Elecsys T-Uptake Calset (K143342)Roche Diagnostics2014-12-19
ST AIA-PACK PROG II Calibrator Set (K143144)Tosoh Bioscience, Inc.2014-12-03
RANDOX ALDOLASE CALIBRATION SERUM (K142181)Randox Laboratories Limited2014-09-18
Elecsys Estradiol III CalSet (K142021)Roche Diagnostics2014-08-12
DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS (K133751)Diamond Diagnostics, Inc.2014-08-08
ACE CALIBRATOR (K141728)SENTINEL CH. SpA2014-07-28
BICARBONATE CALIBRATOR (K141374)Beckman Coulter Ireland, Inc.2014-06-30
CA 125 II CALSET II (K140112)Roche Diagnostics2014-06-06
ST AIA-PACK C-PEPTIDE II CALIBRATOR SET (K140648)Tosoh Bioscience, Inc.2014-04-10
PATHFAST CTNL CALIBRATORS (K130603)Mitsubishi Chemical Medience Corporation2014-03-27
LP(A) CALIBRATORS, AND LP(A) CONTROLS (K132400)Biokit, S.A.2013-12-19
PATHFAST CK-MB-II CALIBRATORS (K130628)Mitsubishi Chemical Medience Corporation2013-10-04
DIAZYME LIPOPROTEIN (A) CALIBRATOR SET, CONTROL SET (K131556)Diazyme Laboratories2013-06-26
DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL) (K130698)Siemens Healthcare Diagnostics2013-04-05
ELITECH CLINICAL SYSTEMS URINE TOTAL PROTEIN PLUS STANDARD 100 MG/DL, ELITECH CLINICAL SYSTEMS URINE CONTROL BI-LEVEL (K122177)Elitechgroup2013-02-15
DIAMOND CALIBRATOR LOW, DIAMOND CALIBRATOR HIGH (K121027)Diamond Diagnostics, Inc.2012-12-20
DIAMOND TOKYO BOEKI ISE MODULE CALIBRATOR 1,2,1-2 (K120591)Diamond Diagnostics, Inc.2012-04-17
DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL (K113373)Siemens Healthcare Diagnostics, Inc.2011-12-30
ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033 (K111952)Beckman Coulter, Inc.2011-08-19
ST AIA-PACK DHEA-S CALIBRATOR SET (K111762)Tosoh Bioscience, Inc.2011-08-05
ABBOTT ARCHITECT LH CALIBRATORS (K111023)Abbott Laboratories2011-06-10
ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491 (K103548)Siemens Healthcare Diagnostics, Inc.2011-06-02
DIMENSION VISTA CDT CAL, DIMENSION VISTA CDT CON L, DIMENSION VISTA CDT CON H (K110169)Siemens Healthcare Diagnostics2011-04-07
ENZYME II CALIBRATOR (K103836)Siemens Healthcare Diagnostics, Inc.2011-02-16
ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 (K103221)Roche Diagnostics2010-12-23
DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL (K103360)Siemens Corp.2010-12-17
DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS (K102638)Diazyme Laboratories2010-11-30
STA-HYBRID HEP CALIBRATOR (K092937)Diagnostica Stago, Inc.2010-08-02
DIAMOND MEDICA ISE MODULE CALIBRANT A MODEL ME-6370D, DIAMOND MEDICA ISE MODULE CALIBRANT B, MODEL ME-5410D (K093357)Diamond Diagnostics, Inc.2010-06-24
ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810 (K100293)Siemens Heatlhcare Diagnostics, Inc.2010-03-19
ABX PENTRA TPU CAL, MODEL A11A01898 (K092570)HORIBA ABX SAS2009-10-16
DIMENSION VISTA SYSTEM ENZYME 5 CALIBRATOR, MODEL KC350 (K083462)Siemens Healthcare Diagnostics2009-02-27
LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623 (K082680)Siemens Healthcare Diagnostics2008-10-10
DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR (K081789)Siemens Healthcare Diagnostics, Inc.2008-09-10
ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10 (K082141)Biokit, S.A.2008-09-03
DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56 (K081319)Siemens Healthcare Diagnostics, Inc.2008-08-04
LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621 (K081683)Siemens Healthcare Diagnostics2008-07-07
ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545 (K080166)Beckman Coulter, Inc.2008-03-19
DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210 (K072717)Dade Behring, Inc.2007-12-12
MISSION OLYMPUS AU ISE CALIBRATORS (K071039)Diamond Diagnostics, Inc.2007-08-08
DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR) (K070552)Dade Behring, Inc.2007-04-30
OXALATE URINE CONTROLS (NORMAL AND ELEVATED) (K062521)Thermo-Electron Corp.2007-03-16
INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS (K070144)Beckman Coulter, Inc.2007-02-01
ABX PENTRA 400: LIPOPROTEINS (K060854)Horiba Abx2006-08-24
CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27 (K062152)Dade Behring, Inc.2006-08-16
DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250 (K061885)Dade Behring, Inc.2006-08-14
DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330) (K061818)Dade Behring, Inc.2006-07-18
DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260 (K061751)Dade Behring, Inc.2006-07-13
DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340) (K061702)Dade Behring, Inc.2006-07-10
BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS (K061139)Bayer Healthcare, LLC2006-07-06
ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585 (K061282)Beckman Coulter, Inc.2006-06-02
CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250 (K060140)Diagnostic Chemicals , Ltd.2006-04-24
ELECSYS TSH CALSET W/MODELS 04738551 (K060754)Roche Diagnostics Corp.2006-04-18
ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10 (K060359)Denka Seiken Co., Ltd.2006-04-14
CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED (K060322)Cliniqa Corporation2006-03-21
FERRITIN CALIBRATOR SET, CATALOG NO. 8203 (K053291)Reference Diagnostics, Inc.2006-03-13
THE EMIT 2000 TACROLIMUS CALIBRATORS (K060371)Dade Behring, Inc.2006-03-09
DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR (K053576)Dade Behring, Inc.2006-02-07
ARCHITECT B12 CALIBRATORS (K053330)Abbott Laboratories2005-12-16
TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET (K052148)Reference Diagnostics, Inc.2005-11-09
ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET (K052982)Roche Diagnostics2005-10-28
ISE COMPENSATOR (K052193)Roche Diagnostics2005-10-03
IRON STANDARD (K052002)Roche Diagnostics Corp.2005-08-22
PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML. (K051012)Salimetrics, LLC2005-07-19
ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET (K050231)Roche Diagnostics Corp.2005-07-06
DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT (K043378)Drew Scientific , Ltd.2004-12-29
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II (K042838)Ortho-Clinical Diagnostics, Inc.2004-12-09
OLYMPUS LACTATE, OSR6193 (K042406)Olympus America, Inc.2004-12-03
ROCHE DIAGNOSTICS ELECSYS AFP CALSET II (K043095)Roche Diagnostics Corp.2004-11-23
VITROS CHEMISTRY PRODUCTS APOA1 AND APOB REAGENTS, CALIBRATOR KITS 21 AND 22 AND APOA1 AND APOB PERFORMANCE VERIFIERS (K042521)Ortho-Clinical Diagnostics, Inc.2004-11-18
ARCHITECT T-UPTAKE CALIBRATORS (A-F) AND CONTROLS (LOW, HIGH) (K042307)Seradyn, Inc.2004-11-03
FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS (K042651)Beckman Coulter, Inc.2004-10-05
ELECSYS FOLATE II CALSET II (K042490)Roche Diagnostics Corp.2004-09-30
AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR (K033860)Wako Chemicals USA, Inc.2004-04-23
OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023 (K040692)Olympus America, Inc.2004-04-08
WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET (K040226)Wako Chemicals USA, Inc.2004-03-25
OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024 (K040471)Olympus America, Inc.2004-03-10
CALIBRATING MATERIAL, CALIBRATING STANDARDS (K033060)Diamond Diagnostics, Inc.2004-03-04
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA (K033786)Ibl GmbH2004-02-27
CO2 CALIBRATOR/DILUENT (K033643)Bayer Healthcare, Diagnostics Division2004-01-08
ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT (K032458)Abbott Laboratories2003-10-06
OLYMPUS PREALBUMIN CALIBRATOR, ODR3029 (K032285)Olympus America, Inc.2003-08-21
VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1 (K031924)Ortho-Clinical Diagnostics2003-08-07
CALIBRATING MATERIAL, CALIBRATING STANDARDS (K031159)Diamond Diagnostics, Inc.2003-06-25
ELECSYS LH CALSET II (K031299)Roche Diagnostics Corp.2003-05-12
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Every clearance here is in the API, with alerts when new ones post.