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510(k) Data Aggregation
K Number
K140100Device Name
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM
Manufacturer
Date Cleared
2014-08-01
(198 days)
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
NIPRO DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TRUE METRIX Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm. The TRUE METRIX Self Monitoring Blood Glucose System is intended to be used by a single person and not shared.
The TRUE METRIX Self Monitoring Blood Glucose System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The TRUE METRIX Self Monitoring Test Strips are for use with the TRUE METRIX Self Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.
The TRUE METRIX PRO Professional Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm and venous whole blood.
The TRUE METRIX PRO Professional Monitoring Blood Glucose System is intended for multiple-patient use in professional healthcare settings. Testing is performed outside the body (in vitro diagnostic use) as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX PRO Professional Monitoring Blood Glucose System is used only with single-use, auto-disabling lancing devices. The system is not to be used for neonates or for the diagnosis or screening of diabetes. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The TRUE METRIX PRO Test Strips are for use with the TRUE METRIX PRO Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or venous whole blood.
Device Description
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K Number
K132072Device Name
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRI PRO PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM
Manufacturer
Date Cleared
2013-08-15
(43 days)
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
NIPRO DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TRUE METRIX Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose(sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm. The TRUE METRIX Self Monitoring Blood Glucose System is intended to be used by a single person and not shared. The TRUE METRIX Self Monitoring Blood Glucose System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonate use. Alternative site testing can only be performed during steady-state blood times (when glucose is not changing rapidly). The TRUE METRIX Test Strips are for use with the TRUE METRIX Self Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.
The TRUE METRIX PROTM Professional Monitoring Blood Glucose System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm and venous whole blood. The TRUE METRIX PRO Professional Monitoring Blood Glucose System is intended for multiple-patient use in professional healthcare settings. Testing is performed outside the body (in vitro diagnostic use) as an aid for monitoring the effectiveness of diabetes control. TRUE METRIX PRO Professional Monitoring Blood Glucose System is used only with single-use, auto-disabling lancing devices. The system is not be used on neonates or for the diagnosis or screening of diabetes mellitus. Alternative site testing can only be performed during steady-state blood glucose conditions. The TRUE METRIX PRO Test Strips are for use with the TRUE METRIX PRO Professional Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm and venous whole blood.
Device Description
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K Number
K120989Device Name
TRUE METRIX SELF-MONITORING BLOOD GLUCOSE SYSTEM, TRUE METRIX PROFESSIONAL MONITORING BLOOD GLUCOSE SYSTEM
Manufacturer
Date Cleared
2013-04-24
(387 days)
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
NIPRO DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TRUE METRIX™ Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples. drawn from the fingertip or forearm. The TRUE METRIX Self Monitoring Blood Glucose System is intended to be used by a single person and not be shared.
The TRUE METRIX™ Self Monitoring Blood Glucose System is intended for selftesting outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TRUE METRIX™ Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes or for neonatal use. Alternative site testing should be done only during steadystate times (when glucose is not changing rapidly).
The TRUE METRIX Test Strips are for use with the TRUE METRIX™ Self Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm.
The TRUE METRIX Control Solution is for use with the TRUE METRIX Self Monitoring Meter and TRUE METRIX Test Strips to check that the meter and the test strip are working together properly and that the test is performing correctly.
The TRUE METRIX PRO Professional Monitoring Blood Glucose System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm and venous whole blood.
The TRUE METRIX PRO Professional Monitoring Blood Glucose System is intended for multiple-patient use in professional healthcare settings. Testing is performed outside the body (in vitro diagnostic use) as an aid for monitoring the effectiveness of diabetes control. TRUE METRIX PRO Professional Monitoring Blood Glucose System is used only with single-use, auto-disabling lancing devices. The system is not to be used on neonates or for the diagnosis or screening of diabetes mellitus. Alternative site testing can only be performed during steady-state blood glucose conditions.
The TRUE METRIX PRO Test Strips are for use with the TRUE METRIX PRO Professional Monitoring Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip or forearm and venous whole blood.
The TRUE METRIX Control Solution is for use with the TRUE METRIX PRO Professional Monitoring Meter and TRUE METRIX PRO Test Strips to check that the meter and test strip are working together properly and that the test is performing correctly.
Device Description
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