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510(k) Data Aggregation
K Number
K161140Device Name
VITROS Chemistry Products Calibrator Kit 3
Manufacturer
ORTHO-CLINICAL DIAGNOSTICS, INC.
Date Cleared
2016-05-20
(28 days)
Product Code
JIX
Regulation Number
862.1150Why did this record match?
Product Code :
JIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For in vitro diagnostic use only. VITROS® Chemistry Products Calibrator Kit 3 is used to calibrate VITROS® 250/350/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ALT, ALKP, AMYL, AST, CK, GGT, LDH and LIPA.
Device Description
VITROS® Calibrator Kit 3 contains three levels of calibrators: Calibrator 1, 2, and 3. The calibrators are lyophilized, multi-analyte products prepared from processed bovine serum to which enzymes, electrolytes, stabilizers, and preservatives have been added. VITROS Chemistry Products Calibrator Kit 3 contains four vials each of lyophilized calibrator 1, 2, and 3 and four vials each of calibrator diluent 1, 2, and 3.
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K Number
K153365Device Name
ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
Manufacturer
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
Date Cleared
2015-12-18
(28 days)
Product Code
JIX
Regulation Number
862.1150Why did this record match?
Product Code :
JIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ADVIA Chemistry Enzyme 1 Calibrator is intended for in vitro diagnostic use in the calibration of Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase P-L (LDPL), Lactate Dehvdrogenase L-P (LDLP), Cholinesterase (CHE), and Lipase (LIP) assays on the ADVIA Chemistry systems.
ADVIA® Chemistry Enzyme 2 Calibrator is intended for in vitro diagnostic use in the calibration of Alanine Aminotransferase (ALT); Alanine Aminotransferase, Concentrated Reagents (ALT c); Alanine Aminotransferase (P5P) (ALTP5P); Alanine Aminotransferase (P5P), Concentrated Reagents (ALTP c); Aspartate Aminotransferase (AST); Aspartate Aminotransferase, Concentrated Reagents (AST_c); Aspartate Aminotransferase (PSP)(ASTP5P); and Aspartate Aminotransferase (P5P), Concentrated Reagents (ASTP_c) assays on the ADVIA Chemistry systems.
Device Description
The ADVIA® Chemistry Enzyme 1 Calibrator and Enzyme 2 Calibrator are liquid, multianalyte, bovine serum albumin based products. Enzyme 1 Calibrator kit consists of six vials of the same calibrator which is ready for use (no preparation is required). The volume per vial is 2.5 mL. Enzyme 2 Calibrator kit consists of six vials of calibrator of the same level which is ready for use (no preparation is required). The volume per vial is 1.5 mL.
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K Number
K151552Device Name
ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
Manufacturer
ELITechGroup
Date Cleared
2015-07-08
(29 days)
Product Code
JIX, JJY
Regulation Number
862.1150Why did this record match?
Product Code :
JIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.
ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra Pro Series Analyzers.
Device Description
ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDAapproved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. ELITROL I and ELITROL II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
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K Number
K140790Device Name
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
Manufacturer
SIEMENS HEALTHCARE DIAGNOSTICS
Date Cleared
2015-06-15
(441 days)
Product Code
JIX, JGJ
Regulation Number
862.1150Why did this record match?
Product Code :
JIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dimension Vista® Magnesium Flex® reagent cartridge (MG) method is an in vitro diagnostic test for the quantitative measurement of magnesium in human serum, plasma and urine on the Dimension Vista® System. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low plasma levels of magnesium) and hypermagnesemia (abnormally high plasma levels of magnesium).
The Dimension Vista® Chemistry 1 Calibrator (CHEM 1 CAL) is an in vitro diagnostic product for the calibration of Blood Urea Nitrogen (BUN),Calcium (CA), Cholesterol (CHOL), Creatinine (CRENCRE2), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyronine Uptake (TU) and Uric Acid (URCA) methods on the Dimension Vista® System.
Device Description
CHEM 1 CAL is a liquid, frozen multi-analyte, bovine serum albumin based product used to calibrate blood urea nitrogen, calcium, cholesterol, creatinine, glucose, lactic acid, magnesium, thyroxine, thyronine uptake and uric acid. The kit consists of six vials, three vials of Calibrator A and three vials of Calibrator B.
The Dimension Vista® MG Flex® reagent cartridge uses a modified methylthymol blue (MTB) complexometric technique. MTB forms a blue complex with magnesium. Calcium interference is minimized by forming a complex between calcium and Ba-EGTA (chelating agent). The amount of MG-MTB complex formed is proportional to the magnesium concentration and is measured using a bichromatic (600 and 510 nm) endpoint technique.
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K Number
K141388Device Name
SYSTEM CALIBRATER
Manufacturer
BECKMAN COULTER IRELAND INC
Date Cleared
2014-07-11
(45 days)
Product Code
JIX
Regulation Number
862.1150Why did this record match?
Product Code :
JIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The System Calibrator is a calibration serum intended to be used for the calibration of ALP, ALT, AST, Amylase, CK-NAC, GGT and LDH enzymes on Beckman Coulter AU480, AU680 and AU5800 analysers. For In Vitro Diagnostic use only.
Device Description
The System calibrator kit is a lyophilized human serum based product intended to provide calibration for AU Enzyme reagents (ALP, ALT, AST, Amylase, CK-NAC, GGT and LDH) for the quantitative determination of the relevant analyte on Beckman Coulter AU analyzers. The following is the kit configuration for the system calibrator: 66300 kit has 20 vials with 5 ml contents for Level 1. The System calibrator is designed for optimal performance on Beckman Coulter AU analyzers. The System calibrator contains lyophilized human serum with chemical additives, preservatives, and enzymes of human, animal and plant origin.
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K Number
K133330Device Name
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN
Manufacturer
Roche Diagnostics
Date Cleared
2013-11-26
(25 days)
Product Code
JIX, JJY
Regulation Number
862.1150Why did this record match?
Product Code :
JIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
C.f.a.s. (Calibrator for automated systems) PAC (Prealbumin-ASLO-Ceruloplasmin) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
C.f.a.s. (Calibrator for automated systems) Proteins is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
PreciControl ClinChem Multi 1 is for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets. PreciControl ClinChem Multi 2 is for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
Precinorm Protein and Precipath Protein are for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
Device Description
C.f.a.s. Proteins is a liquid ready-to-use calibrator based on human serum. The concentrations of the components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers.
C.f.a.s. PAC is a lyophilized calibrator based on human serum. The concentrations of the components have been adjusted to ensure optimal calibration of the appropriate Roche methods on clinical chemistry analyzers.
PreciControl ClinChem Multi 1 and 2 are lyophilized controls based on human serum. The adjusted concentrations and activities of the components of PCCC Multi 1 are usually in the normal range or at the normal/pathological threshold. The adjusted concentrations and activities of the components of PCCC Multi 2 are usually in the pathological range.
Precinorm Protein and Precipath Protein are liquid ready-for-use control sera based on human serum. The concentrations of the components of Precinorm Protein are usually in the normal range or at the normal/pathological threshold. The concentrations of the components of Precipath Protein are usually in the pathological range.
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K Number
K130765Device Name
ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II
Manufacturer
ELITECHGROUP
Date Cleared
2013-04-04
(15 days)
Product Code
JIX, JJY
Regulation Number
862.1150Why did this record match?
Product Code :
JIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ELITech Clinical Systems ELICAL 2 is a multi-parametric calibrator for in vitro diagnostic use in the calibration of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
ELITech Clinical Systems ELITROL I & ELITROL II are multi-parametric control sera for in vitro diagnostic use in quality control of quantitative ELITech Clinical Systems methods on ELITech Clinical Systems Selectra analyzers.
Device Description
ELITech Clinical Systems ELICAL 2 is a lyophilized calibrator based on human serum containing constituents to ensure optimal calibration. ELICAL 2 is prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
ELITech Clinical Systems ELITROL I and ELITROL II are two level quality control products consisting of lyophilized human serum containing constituents at desired levels. Elitrol I and Elitrol II are prepared exclusively from the blood of donors tested individually and found to be negative for HbsAg and to antibodies to HCV and HIV according to FDA-approved methods or methods in compliance with the European Directive 98/79/EC, Annex II, List A.
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K Number
K123321Device Name
DIMENSION CHEMISTRY III CALIBRATORY
Manufacturer
SIEMENS HEALTHCARE DIAGNOSTICS
Date Cleared
2013-02-15
(112 days)
Product Code
JIX
Regulation Number
862.1150Why did this record match?
Product Code :
JIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CHEM III CAL is an in vitro diagnostic product for the calibration of Ammonia (AMM), Carbon Dioxide (EC02) and Ethyl Alcohol (ETOH) assays on the Dimension® clinical chemistry system.
Device Description
The Chemistry III Calibrator (CHEM III CAL) is a three level, liquid calibrator. It is packaged as a kit of six vials, two vials each of Levels 1, 2 and 3 with 2.5 mL per vial. CHEM III CAL is a multianalyte, aqueous product containing ammonium bicarbonate, sodium carbonate and ethyl alcohol.
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K Number
K123372Device Name
ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
Manufacturer
ABBOTT LABORATORIES
Date Cleared
2013-01-14
(74 days)
Product Code
JIX
Regulation Number
862.1150Why did this record match?
Product Code :
JIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Abbott Lipid Multiconstituent Calibrator is an in vitro diagnostic product intended for the calibration of Abbott Apolipoprotein A1, Apolipoprotein B, HDL-Cholesterol and LDL-Cholesterol assays on the ARCHITECT c8000 clinical chemistry analyzer.
Device Description
This is an in vitro diagnostic product intended for use as a calibrator in clinical chemistry assays. Lipid Multiconstituent Calibrator (LipidMCC) contains Apolipoprotein A1, Apolipoprotein B. HDL-Cholesterol and LDL-Cholesterol in a lyophilized human serum-based matrix. The concentrations and activities are suitable for calibration of the Abbott ARCHITECT c8000. LipidMCC contains one level of the four analytes in a lyophilized human serum-based matrix.
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K Number
K122398Device Name
RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS
Manufacturer
Siemens Healthcare Diagnostics Inc.
Date Cleared
2012-10-12
(66 days)
Product Code
JIX
Regulation Number
862.1150Why did this record match?
Product Code :
JIX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RAPIDPoint® 500 System measurement cartridge with calibrators is an in vitro diagnostic product for the calibration of the analytes on the RAPIDPoint® 500 System. The analytes measured are partial pressure of carbon dioxide (pCO2), partial pressure of oxygen (pO2), pH, Sodium (Na*), Potassium (K*), ionized Calcium (Ca**), Chloride (Cl7), Glucose (Glu), total hemoglobin (tHb), Neonatal Bilirubin and Lactate (Lac).
Device Description
The RAPIDPoint® 500 System consists of four (4) calibrators contained in the measurement cartridge and wash/waste cartridge that are used to calibrate the following analytes: pH, partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), Sodium (Na ), Potassium (K ), ionized Calcium (Ca *), Chloride (Cl), Glucose (Glu), total hemoglobin (tHb) and Lactate (Lac). There is no unique calibration measurement for Neonatal Bilirubin (nBili) as the tHb calibration is used.
The measurement cartridge contains the following calibrators: 200 Cal, Reagent C and Low Sulfite Zero Cal. The wash/waste cartridge contains the wash reagent.
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