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510(k) Data Aggregation
K Number
K132821Device Name
AGAMATRIX HEALTH MANAGER
Manufacturer
AGAMATRIX INC
Date Cleared
2013-11-20
(72 days)
Product Code
NBW, JQP
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
AGAMATRIX INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AgaMatrix Health Manager is intended for single patient use. It is an accessory to blood glucose monitoring systems to assist in the review, analysis and evaluation of glucose results to aid in diabetes and health management. The AgaMatrix Health Manager collects data from AgaMatrix manufactured glucose meters and allows adding, editing, and viewing additional health data. The AgaMatrix Health Manager is not intended to provide automated treatment guidance or decisions, nor is it to be used as a substitute for professional healthcare advice.
Device Description
The AgaMatrix Health Manager (app) is an optional software accessory for blood glucose meters manufactured by AgaMatrix. It is a digital logbook and diabetes tool designed to operate using an iPhone or iPod touch. An individual can manually enter blood glucose readings or can download readings directly to the app installed on an iPhone or iPod touch from the AgaMatrix meter by using the AgaMatrix Cable to connect the meter to the connector of the iPhone or iPod touch. The app will allow the user to manually enter carbohydrate, insulin, and weight information. Users will have the ability to have their data from the AgaMatrix Health Manager automatically uploaded to the AgaMatrix Health Manager cloud portal for back-up. The cloud portal will enable access to the health information in a web browser. Users will have the ability to create and edit their profile, set goals, and download their information as a .csv file.
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K Number
K130535Device Name
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION
Manufacturer
AGAMATRIX INC
Date Cleared
2013-04-17
(47 days)
Product Code
NBW, JQP
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
AGAMATRIX INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The iBGStar™ Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels from fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. It is intended to be used by a single patient and should not be shared. The iBGStar™ Blood Glucose Monitoring 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 iBGStar™ Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.
The iBGStar Diabetes Manager Application is intended for use in the home with the capability of sending glucose readings through email to an individual's healthcare professional in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the iBGStar Blood Glucose Monitoring System.
Device Description
The iBGStar Blood Glucose Monitoring System (BGMS) consists of:
- iBGStar Blood Glucose Meter .
- . BGStar Test Strips
- BGStar Control Solution .
The iBGStar. Diabetes Manager Application (DMA) is an optional software accessory for the iBGStar Blood Glucose Monitoring System. It is a digital logbook and diabetes tool designed to operate using an iPhone or iPod touch. An individual can manually enter blood glucose readings or can download readings directly to the DMA installed on an iPhone or iPod touch from the iBGStar meter.
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K Number
K103544Device Name
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER APPLICATION, REV D
Manufacturer
AGAMATRIX INC
Date Cleared
2011-12-07
(370 days)
Product Code
NBW, CGA, JJX, JQP
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
AGAMATRIX INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The iBGStar™ Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. It is intended to be used by a single patient and should not be used for testing multiple patients. The iBGStar™ Blood Glucose Monitoring 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 iBGstar Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates.
BGStar™ Test Strips are for use with the iBGStar™ Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. Palm and foream testing (Alternative Site Testing) should be done only during steady-state times (when glucose is not changing rapidly).
BGStar Control Solutions are for use with the iBGStar™ Blood Glucose Meter and BGStar Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The iBGStar Diabetes Manager Application is intended for use in the capability of sending glucose readings through email to an individual's healthcare professional in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the iBGStar Blood Glucose Monitoring System.
Device Description
The iBGStar Blood Glucose Monitoring System consists of: iBGStar Blood Glucose Meter, BGStar Test Strips, BGStar Control Solution.
The iBGStar Diabetes Manager Application is an optional data management software accessory for use with the iBGStar Blood Glucose Monitoring System.
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K Number
K083265Device Name
JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381
Manufacturer
AGAMATRIX INC
Date Cleared
2009-02-03
(90 days)
Product Code
NBW, CGA, JJX
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
AGAMATRIX INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AgaMatrix JAZZ Wireless™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
AgaMatrix JAZZ Wireless™ Blood Glucose Meter is intended for use with AgaMatrix JAZZ Blood Glucose Test Strips for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
AgaMatrix JAZZ Blood Glucose Test Strips are intended for use with AgaMatrix JAZZ Wireless 110 Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
AgaMatrix WaveSense™ Control Solution is intended for use with the AgaMatrix JAZZ Wireless M Meter and AgaMatrix JAZZ Wireless " Test Strips as a quality control check to verify the accuracy of blood glucose test results.
Device Description
The AgaMatrix Jazz Wireless™ Blood Glucose Monitoring System which is codeless, includes a meter with batteries, compact carrying case, lancing device, lancets, control solution and owner's booklet. Test Strips and control solution are sold separately.
It is intended for over-the counter home use by diabetics to monitor their blood glucose levels or for use in a clinical setting by healthcare professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument.
The modification of Jazz Wireless™ blood glucose system allows users to upload glucose readings from the meter to a blue tooth enabled PC without the use of a USB cable.
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K Number
K052762Device Name
LIBERTY BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-0067
Manufacturer
AGAMATRIX INC
Date Cleared
2006-01-23
(115 days)
Product Code
NBW, CGA, JJX
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
AGAMATRIX INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AgaMatrix LibertyTM Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip and palm of the hand. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
AgaMatrix Liberty™ Blood Glucose Meter is intended for use with AgaMatrix Liberty™ Blood Glucose Test Strips for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip and palm of the hand. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
AgaMatrix Liberty™ Blood Glucose Test Strips are intended for use with AgaMatrix Liberty™ Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood from the fingertip and palm of the hand. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
AgaMatrix Liberty™ Control Solutions are intended for use with the AgaMatrix Liberty™ Meter and AgaMatrix Liberty™ Test Strips as a quality control check to verify the accura results.
Device Description
The AgaMatrix Liberty™ Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, quick start guide, reference guide, owner's booklet, and warranty/ registration card. Test Strips, Lancing device, Lancets, and Control Solution are purchased separately.
It is intended for over-the-counter home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by healthcare professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument.
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