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510(k) Data Aggregation
K Number
K100398Device Name
SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM
Manufacturer
STANDARD DIAGNOSTICS, INC.
Date Cleared
2010-06-09
(113 days)
Product Code
NBW
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
STANDARD DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SmartLink™ GOLD blood glucose monitoring system is indicated for monitoring glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm. SmartLink™ GOLD meter must be used with SmartLink™ GOLD blood glucose test strip and SD Control solutions.
The SD control solutions Level M and Level H are for use with SmartLink™ GOLD test system as quality controls to verify the accuracy of blood glucose test results.
Testing is done outside the body (in vitro diagnostic use).
This system is indicated for home (over-the-counter; OTC) by person with diabetes, or in · clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
This system should not be used for the screening or diagnosis of diabetes or for testing neonates.
Device Description
The SmartLink™ GOLD Blood Glucose System is an Rx/OTC blood glucose system to be used by professional healthcare personnel or diabetics at home to measure the glucose concentration for aiding diabetes management.
The SmartLink™ GOLD Blood Glucose System consists of a SmartLink™ GOLD Blood Glucose Meter which measures and displays test results, SmartLink™ GOLD test strip, lancet and lancing device for blood sampling, control solution to check the meter and test strip, check strip to check the meter, 3 V battery (type 2032) for power, carrying case, user guide, packaging inserts for the test strip and control solution and a Quick Guide for helping the user with a self test diary to document test results for monitoring the trend of blood glucose.
The system is a battery-operated portable device and stores 500 test results in memory. The user can search the stored results with three presentations of 7, 14 and 30-day averages of test results stored in memory: normal, pre-meal and post-meal state averages. The system can set the beep, hypo warning, date, time, post-meal alarm and alarm. The svstem can also set the pre-meal and postmeal mark. Test results are displayed with mg/dL unit. A check strip allows the meter to check a problem and the control solution allows the meter and test strip to be checked.
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K Number
K082683Device Name
SD CHECK GOLD
Manufacturer
STANDARD DIAGNOSTICS, INC.
Date Cleared
2009-12-08
(449 days)
Product Code
NBW, CGA, JJX
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
STANDARD DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SD CHECK GOLD Blood glucose monitoring system is indicated for monitoring glucose in fresh capillary whole blood samples drawn from the fingertip, palm, forearm or upper arm. SD CHECK GOLD meter must be used with SD CHECK GOLD blood glucose test strip and SD CHECK GOLD control solutions.
The SD Check Gold control solutions Level M and Level H are for use with SD Check Gold test system as quality controls to verify the accuracy of blood glucose test results.
Testing is done outside the body (in vitro diagnostic use).
This system is indicated for home (over-the-counter; OTC) by person with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
This system should not be used for the screening or diagnosis of diabetes or for testing newborns.
Device Description
SD CHECK GOLD blood glucose system is applicable to monitor blood glucose in capillary whole blood.
SD CHECK GOLD blood glucose monitoring system is comprised of the following.
- SD CHECK GOLD blood glucose meter
- SD CHECK GOLD blood glucose test strip i
- SD CHECK GOLD control solution -
- i SD CHECK GOLD check strip
A drop of blood sample from the finger prick works with glucose oxidase and the mediators in the test strip to make a small electric current proportional to the glucose concentration in the blood. The meter reads the current and displays the blood glucose result equivalent to the current.
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K Number
K031798Device Name
GOOD MORNING TEST
Manufacturer
STANDARD DIAGNOSTICS, INC.
Date Cleared
2003-11-12
(155 days)
Product Code
LCX
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
STANDARD DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Good Morning Test kit is a qualitative chromatographic immunoassay, which determines whether a woman is pregnant or not by identifying the presence of hCG in urine.
Device Description
The Good Morning Test kit is a qualitative chromatographic immunoassay
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