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510(k) Data Aggregation
K Number
K152300Device Name
Glucommander
Manufacturer
GLYTEC, LLC
Date Cleared
2017-08-04
(721 days)
Product Code
NDC
Regulation Number
868.1890Why did this record match?
Applicant Name (Manufacturer) :
GLYTEC, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Glucommander System is a glycemic management tool intended to evaluate current as well as cumulative patient blood glucose values coupled with patient information including age, weight and height, and, based on the aggregate of these measurement parameters, whether one or many, recommend an IV dosage of insulin, glucose or saline or a subcutaneous basal and bolus insulin dosing recommendation to adjust and maintain the blood glucose level towards a configurable physician-determined target range.
The Glucommander System is indicated for use in adult and pediatric (ages 2 - 17 years) patients.
The G+ System logic is not a substitute for, but rather an adjunct to clinical reasoning. The measurements and calculations generated are intended to be used by qualified and trained medical personnel in evaluating patient conditions in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional's clinical judgment. No medical decision should be based solely on the recommended quidance provided by this software program.
The indications for use are identical to the predicate device.
Device Description
The Glucommander System is a software algorithm device intended to evaluate the current as well as cumulative patient blood glucose values and, based on the aggregate of those measurements, whether one or many, recommend a dosage of insulin, glucose, or saline in order to direct the blood glucose level towards a predetermined target range. Once that target blood glucose range has been reached, the system's function is to recommend a titration of insulin, glucose, and saline for the purpose of maintaining the patient's blood glucose level in that target range. The system is programmed to provide intravenous dosing of glucose, saline, and insulin, as well as subcutaneous dosing of insulin for both pediatric (ages 2-17 years) and adult patients.
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K Number
K113853Device Name
G+ SYSTEM
Manufacturer
GLYTEC, LLC
Date Cleared
2012-05-08
(131 days)
Product Code
NDC
Regulation Number
868.1890Why did this record match?
Applicant Name (Manufacturer) :
GLYTEC, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Glucommander System is a glycemic management tool intended to evaluate current and cumulative patient blood glucose values and coupled with patient information including age, weight and height, and, based on the aggregate of these measurement parameters, whether one or many, recommend an IV dosage of insulin, glucose or saline or a subcutaneous basal and bolus insulin dosing recommendation to adjust and maintain the blood glucose level towards a configurable clinician determined target range.
The Glucommander System is indicated for use in adult and pediatric (ages 2 - 17 years) patients.
The Glucommander System logic is not a substitute for, but rather an adjunct to clinical reasoning. The measurements and calculations generated are intended to be used by qualified and trained medical personnel in evaluating patient conditions in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional's clinical judgment. No medical decision should be based solely on the recommended guidance provided by this software program.
Device Description
The Glytec, LLC Glucommander System is a software device used to evaluate current and cumulative patient blood glucose values, and, based on the aggregate of those measurements, whether one or many, recommend an IV dosage of insulin, glucose or saline to direct the blood glucose level towards a predetermined target range. Once that target blood glucose range has been reached, the system's function is to recommend a titration of insulin, glucose, and saline for the purpose of maintaining the patient's blood glucose level in that target range. The system is programmed to provide intravenous dosing of glucose, saline, and insulin, as well as subcutaneous dosing of insulin for both pediatric (ages 2 - 17 years) and adult patients.
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K Number
K101344Device Name
G+ SYSTEM
Manufacturer
GLYTEC, LLC (FORMALLY KNOWN AS GLUCOTEC, INC.)
Date Cleared
2010-06-28
(46 days)
Product Code
NDC
Regulation Number
868.1890Why did this record match?
Applicant Name (Manufacturer) :
GLYTEC, LLC (FORMALLY KNOWN AS GLUCOTEC, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The G+ System is intended to evaluate the current as well as cumulative patient blood glucose values, and, based on the aggregate of those measurements, whether one or many, regulate the infusion of I.V. fluids, through and I.V. infusion pump, and drive the blood glucose level towards a predetermined target range. Once that target blood glucose range has been reached, the system's function is to recommend a titration of insulin, glucose, and saline for the purpose of maintaining the patient's blood glucose level in that target range. The system is provide intravenous dosing of glucose, saline, and insulin, as well as subcutaneous dosing of glucose and insulin.
The G+ System logic is not a substitute for, but rather an assist to clinical reasoning. The measurements and calculations generated are intended to be used by qualified and trained medical personnel in evaluating patient conditions in conjunction with clinical history, symptoms, and other diagnostic measurements, as well as the medical professional's clinical judgment. No medical decision should be based solely on the recommended guidance provided by this software program.
Device Description
The Glytec, LLC G+ System is a software device intended to evaluate the current as well as cumulative patient blood glucose values, and, based on the aggregate of those measurements, whether one or many, regulate the infusion of I.V. fluids, through an I.V. infusion pump, and direct the blood glucose level towards a predetermined target range. Once that target blood glucose range has been reached, the system's function is to recommend a titration of insulin, glucose, and saline for the purpose of maintaining the patient's blood glucose level in that target range. The system is provide intravenous dosing of glucose, saline, and insulin, as well as subcutaneous dosing of glucose and insulin.
The device is available in a Standard Edition or server based Enterprise Edition.
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