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510(k) Data Aggregation
K Number
K221072Device Name
TRUEdraw Lancing Device, Mini Lancing Device
Manufacturer
Trividia Health
Date Cleared
2022-10-18
(189 days)
Product Code
QRL
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
Trividia Health
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TRUEdraw Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.
The Mini Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.
The TRUEdraw Lancing Device/ Mini Lancing Device is for use only on a single patient in a home setting.
The TRUEdraw Lancing Device/ Mini Lancing Device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
Device Description
The TRUEdraw Lancing Device/ Mini Lancing Device is a reusable blood lancet holder intended to be used in conjunction with a sterile, single-use blood lancet for obtaining a capillary blood sample for testing purposes from the fingertip and from alternative sites, such as the forearm. TRUEdraw Lancing Device/ Mini Lancing Device is intended for multiple use by a single patient.
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K Number
K143548Device Name
TRUE METRIX GO Self Monitoring Blood Glucose System
Manufacturer
Trividia Health, Inc.
Date Cleared
2016-04-01
(473 days)
Product Code
NBW, LFR
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
Trividia Health, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TRUE METRIX GO Self Monitoring Blood Glucose System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The TRUE METRIX GO Self Monitoring Blood Glucose System is intended to be used by a single person and not shared.
The TRUE METRIX GO 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 GO Self Monitoring Blood Glucose System should not be used for the diagnosis or screening of diabetes, for neonatal use or for alternative site testing.
The TRUE METRIX Self Monitoring Blood Glucose Test Strips are for use with the TRUE METRIX GO Self Monitoring Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
Device Description
Not Found
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