Search Results
Found 8 results
510(k) Data Aggregation
K Number
K110035Device Name
INDIKO
Manufacturer
THERMO FISHER SCIENTIFIC OY
Date Cleared
2011-06-28
(174 days)
Product Code
JJE, CFR
Regulation Number
862.2160Why did this record match?
Applicant Name (Manufacturer) :
THERMO FISHER SCIENTIFIC OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used.
The Indiko Glucose (HK) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer.
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Device Description
The Indiko is automated random access discrete photometric analyzer, capable of performing up to 30 photometric tests.
The sample disk has an integrated barcode reader which allows cup/tube recognition. The barcode reader can read the following codes: code 128, USS Codabar, interleaved 2 of 5 and code 39 with check digit.
Reaction cells are discrete disposable (single use) multicell cuvettes with 10 reaction measurement cells in a row. On-board capacity of 36 multicell cuvettes (equal to 360 reaction cells), with continuous loading capability, typically 2 hours walk-away time. The quality of the reaction cells is checked at the start of the routine work automatically. The measurements are performed at 37℃.
The analyzer incorporates robotics, computer, and communication technology to render simple and reliable long-term operation. The operating system works with Windows® 7. The user interface software is graphical. The data input can be done online or by touch screen or mouse or keyboard.
Reagents are liquid, the reagent bottles are placed on the reagent/sample disk, which holds maximum 30 positions, the reagent/sample disk is cooled 10℃ below ambient temperature.
Ask a Question
K Number
K073295Device Name
UREA/BUN, SCAL, NORTROL, ABTROL
Manufacturer
THERMO FISHER SCIENTIFIC OY
Date Cleared
2008-05-29
(188 days)
Product Code
CDQ, JIX, JJY
Regulation Number
862.1770Why did this record match?
Applicant Name (Manufacturer) :
THERMO FISHER SCIENTIFIC OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Urea / BUN test system is intended for quantitative in vitro diagnostic measurement of Urea / BUN (urea nitrogen) concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.
For in vitro diagnostic use for quantitative testing on T60 instrument. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.
For in vitro diagnostic use for quantitative testing on T60 instrument. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.
Device Description
The Urea / BUN test system is intended for quantitative in vitro diagnostic measurement of Urea / BUN (urea nitrogen) concentration in human serum or plasma.
sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.
Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet.
Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet.
Ask a Question
K Number
K073612Device Name
URIC ACID (AOX), SCAL, NORTROL, ABTROL
Manufacturer
THERMO FISHER SCIENTIFIC OY
Date Cleared
2008-05-23
(154 days)
Product Code
JIX, JJY, KNK
Regulation Number
862.1150Why did this record match?
Applicant Name (Manufacturer) :
THERMO FISHER SCIENTIFIC OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Uric Acid (AOX) test system is intended for quantitative in vitro diagnostic measurement of uric acid concentration in human serum or plasma. Such measurements are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure and gout.
For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy
For in vitro diagnostic use for quantitative testing on T60 instrument. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.
For in vitro diagnostic use for quantitative testing on T60 instrument. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.
Device Description
Not Found
Ask a Question
K Number
K073191Device Name
ALKALINE PHOSPHATASE (IFCC) PLUS, ECAL, NORTROL, ABTROL
Manufacturer
THERMO FISHER SCIENTIFIC OY
Date Cleared
2008-02-28
(107 days)
Product Code
CJE, JIX, JIY
Regulation Number
862.1050Why did this record match?
Applicant Name (Manufacturer) :
THERMO FISHER SCIENTIFIC OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For in vitro diagnostic use in the quantitative determination of alkaline phosphatase (orthophosphoric - monoester phospho-hydrolase, alkaline optimum, EC 3.1.3.1) activity in human serum or plasma on T60 instruments according to the IFCC method.
The Alkaline Phosphatase test system is intended for quantitative in-vitro diagnostic determination of the activity of the enzyme Alkaline Phosphatase in serum and plasma on T60 instrument according to the IFCC method. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver and bone diseases.
For in vitro diagnostic use on T60 instrument. eCal is used as a calibrator for enzyme tests using methods defined by Thermo Fisher Scientific Oy.
For in vitro diagnostic use for quantitative testing on T60 instrument. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.
For in vitro diagnostic use for quantitative testing on T60 instrument. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.
Device Description
Alkaline Phosphatase (IFCC) plus, codes 981832 and 981833. Common name: Alkaline Phosphatase (IFCC). Classification: Clinical Chemistry, Class II, Product Code: CJE.
eCal, code 981830. Common Name: Calibrator, Multi-Analyte Mixture. Classification: Clinical Chemistry, Class II, Product Code: JIX.
Nortrol, code 981043. Common Name: Multi-analyte Controls (Assayed and unassayed). Classification: Clinical Chemistry, Class I, Product Code: JJY.
Abtrol, code 981044. Common Name: Multi-analyte Controls (Assayed and unassayed). Classification: Clinical Chemistry, Class I, Product Code: JJY.
Ask a Question
K Number
K073355Device Name
CALCIUM, SCAL, NORTROL, ABTROL
Manufacturer
THERMO FISHER SCIENTIFIC OY
Date Cleared
2008-02-28
(91 days)
Product Code
CJY, JIX, JJY
Regulation Number
862.1145Why did this record match?
Applicant Name (Manufacturer) :
THERMO FISHER SCIENTIFIC OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Calcium test system is intended for in vitro diagnostic use in the quantitative determination of the calcium concentration in human serum or plasma on T60 instruments. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
For in vitro diagnostic use on T60 instrument. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.
For in vitro diagnostic use for quantitative testing on T60 instrument. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.
For in vitro diagnostic use for quantitative testing on T60 instrument. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Instruments using methods defined by Thermo Fisher Scientific Oy.
Device Description
Not Found
Ask a Question
K Number
K070824Device Name
CREATININE (ENZYMATIC)
Manufacturer
THERMO FISHER SCIENTIFIC OY
Date Cleared
2007-12-03
(252 days)
Product Code
JFY, JIX, JJY
Regulation Number
862.1225Why did this record match?
Applicant Name (Manufacturer) :
THERMO FISHER SCIENTIFIC OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CREATININE (Enzymatic) is intended for quantitative in-vitro diagnostic determination of creatinine concentration in human serum, plasma (Li-heparin) or urine using T60 Clinical Chemistry Analyzers. Measurement of creatinine levels aids in the diagnosis and treatment of certain renal disease, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
sCal: For in vitro diagnostic use on T60 analyzer. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Oy.
Nortrol: For in vitro diagnostic use for quantitative testing on T60 analyzer. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.
Abtrol: For in vitro diagnostic use for quantitative testing on T60 analyzer. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.
Device Description
Not Found
Ask a Question
K Number
K071340Device Name
CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL
Manufacturer
THERMO FISHER SCIENTIFIC OY
Date Cleared
2007-10-05
(144 days)
Product Code
KHS, JIX, JJY
Regulation Number
862.1160Why did this record match?
Applicant Name (Manufacturer) :
THERMO FISHER SCIENTIFIC OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Carbon Dioxide (CO2) reagent is intended for the quantitative determination of total carbon dioxide in human serum and plasma (Li-heparin) on T60 analyzer.
Bicarbonate measurements, in conjunction with tests such as glucose, urea, sodium, portassium and chloride, are used in the assessment of disturbances of acid base balance resulting from metabolic or respiratory causes
sCal: For in vitro diagnostic use on T60 analyzer. sCal is used as a multicalibrator for quantitative measurements using methods defined by Thermo Fisher Scientific Over
Nortrol: For in vitro diagnostic use for quantitative testing on T60 analyzer. Nortrol is a control serum to monitor trueness and precision of the analytes listed in the separate Nortrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.
Abtrol: For in vitro diagnostic use for quantitative testing on T60 analyzer. Abtrol is a control serum to monitor trueness and precision of the analytes listed in the separate Abtrol value sheet. The given values are valid for T60 Clinical Chemistry Analyzers using methods defined by Thermo Fisher Scientific Oy.
Device Description
Not Found
Ask a Question
K Number
K071580Device Name
AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROL
Manufacturer
THERMO FISHER SCIENTIFIC OY
Date Cleared
2007-10-03
(117 days)
Product Code
CIT, JIX, JJY
Regulation Number
862.1100Why did this record match?
Applicant Name (Manufacturer) :
THERMO FISHER SCIENTIFIC OY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AST/ GOT (IFCC) test system is intended for quantitative in-vitro diagnostic determination of the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma on T60 instrument. Measurement of aspartate amino transferase levels aids in the diagnosis and treatment of certain types of liver and heart disease.
Auxiliary product: Pyridoxal Phosphate
Auxiliary reagent for in vitro diagnostic use in the quantitative determination of ALT (GPT) and AST (GOT) codes 981363 and 981771, activity according to the IFCC recommendations with 3-reagent method on T60 instrument.
For eCal Calibrator, Nortrol and Abtrol see intended use.
Device Description
Not Found
Ask a Question
Page 1 of 1