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510(k) Data Aggregation
K Number
K022108Device Name
THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-050
Manufacturer
THERMO DMA, INC.
Date Cleared
2002-07-25
(27 days)
Product Code
JIX, CAL
Regulation Number
862.1150Why did this record match?
Applicant Name (Manufacturer) :
THERMO DMA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Thermo DMA Data-Cal Calibrator is intended for use in the calibration of clinical chemistry assays.
Device Description
Thermo DMA's Data-Cal is intended for use as a reference material in the single point calibration of clinical chemistry procedures.
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K Number
K012878Device Name
THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-609
Manufacturer
THERMO DMA, INC.
Date Cleared
2001-10-16
(49 days)
Product Code
JIS, CAL
Regulation Number
862.1150Why did this record match?
Applicant Name (Manufacturer) :
THERMO DMA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This reagent is intended for use with Thermo Trace Ammonia Reagent(510(k) number K(74620) to establish points of reference that are used in the determination of Ammonia in human plasma.
Device Description
The Thermo Trace Ammonia Standards are aqueous (ammonia free deionized water) solutions of Ammonium Sulfate (Merck GR ACS (ammonia rece delonioa navis) preservative (Sodium Azide). The Thermo Trace Ammonia Standard set is intended for in vitro diagnostic use with Thermo Trace Ammonia Reagent (K974620) to establish points of reference that are used in the determination of Ammonia in human plasma.
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K Number
K012518Device Name
TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113
Manufacturer
THERMO DMA, INC.
Date Cleared
2001-10-09
(64 days)
Product Code
CJE, ALK
Regulation Number
862.1050Why did this record match?
Applicant Name (Manufacturer) :
THERMO DMA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This reagent is intended for the in vitro quantitative determination of Alkaline Phosphatase in human serum and plasma. Measurements of Alkaline Phosphatase or its isoenzymes are used as in the diagnosis and treatment of liver, bone, parathyroid and intestinal diseases.
Device Description
TRACE Scientifics' alkaline phosphatase reagents are intended for the in vitro quantitative determination of alkaline phosphatase in human serum and plasma. The TRACE ALP - AMP (IFCC) method is based on the recommendations of the International Federation of Clinical Chemistry (IFCC). This method utilizes 4-nitrophenylphosphate (4-NPP) as the substrate. Under the optimized conditions ALP present in the sample catalyses the following transphosphorylation reaction. At the pH of the reaction 4-NPP has an intense yellow color. The reagent also contains a metal ion buffer system to ensure that optimal concentrations of metal ions are maintained. The metal ion buffer can also chelate other potentially inhibitory ions, which may be present. The reaction is monitored by measuring the increase in absorbance at 405 nm, which is proportional to the activity of ALP in the serum.
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K Number
K012525Device Name
THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/235
Manufacturer
THERMO DMA, INC.
Date Cleared
2001-10-04
(59 days)
Product Code
LCP, ASS
Regulation Number
864.7470Why did this record match?
Applicant Name (Manufacturer) :
THERMO DMA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This reagent is intended for the in vitro quantitative determination of Fructosamine (glycated protein) in human serum when run on the Hitachi 704 automated chemistry analyzer. Measurements of fructosamine are used as an aid for short-term glycemic control related to diabetes management.
Device Description
Thermo DMA's fructosamine reagent is intended for the in vitro quantitative determination of Fructosamine in human serum. Under alkaline conditions, analytes with Amadori rearrangements, such as Fructosamine, have reducing activity that can be differentiated from other reducing substances. In the presence of carbonate buffer, fructosamine rearranges to the eneaminol form, which reduces Nitroblue tetrazolium (NBT) to a formazan. The absorbance at 530 nm is measured at two time points and the absorbance change is proportional to the fructosamine concentration. A 10-minute incubation is employed to allow fast reacting interfering reducing substances to react. Removal of endogenous glucose is not required due to the fact that a pH of greater than 11 is required for glucose to reduce NBT.
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