(244 days)
In vitro diagnostic use for the quantitative measurement of glucose in fresh capillary whole blood
The AMD Home Health Monitoring System consists of the home-use, blood glucose meter, the AMD Home Health Glucose Monitor, with accessories, and the companion physician's monitoring device, the AMD PC Monitoring Station. The AMD Home Health Glucose Monitor contains the glucose measurement technology of the MediSense Pen 2 device. MediSense Companion 2 Test Strips and Control Solutions are to be used with the AMD Home Health Glucose Monitor. The AMD Home Health Glucose Monitor testing system has been developed to allow rapid measurement of blood glucose (D-glucose) by using an electrochemical detection technique. This biosensor system employs a disposable dry reagent strip technology, based on the glucose oxidase method for glucose determination. Each test strip features an electrode containing the enzyme glucose oxidase (Aspergillus niger). When a blood drop is applied to the target area of the test strip, the glucose oxidase catalyzes the oxidation of glucose in the drop to produce gluconic acid. During the reaction, electrons are transferred by way of an electrochemical mediator to the electrode surface. This in turn generates a current that is measured by the Home Health Glucose Monitor. The size of the current generated is proportional to the amount of glucose present in the blood drop, thus giving an accurate reading of the blood glucose concentration. The computer-controlled Home Health Glucose Monitor facilitates efficient blood glucose testing and has an internal modem for the transmission of glucose test results to the remote AMD PC Monitoring Station. The AMD PC Monitoring Station is a personal computer-based system used in the clinical setting (e.g., physician's office, nurse's station, etc.) to receive and process blood glucose test data transmitted by the Home Health Glucose Monitor. This device allows remote clinical review of test results obtained in the patient's home.
The provided text is a 510(k) summary for the AMD Home Health Monitoring System, a self-monitoring blood glucose device. It details the device description, intended use, predicate devices, and a comparison chart. However, it does not contain information about acceptance criteria, specific study results, sample sizes, expert qualifications, or ground truth establishment relevant to the requested questions. The document focuses on demonstrating substantial equivalence to predicate devices based on design and operational characteristics, not on presenting performance study data against pre-defined acceptance criteria.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using only the provided text, as this information is absent.
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Image /page/0/Picture/1 description: The image shows the letters "AMD" in a simple, sans-serif font. The letters are white against a black background, creating a high contrast. The letters are slightly distorted, possibly due to the image quality or the original source of the text.
152 WEST WISCONSIN AVE
ADVANCED MEDICAL DEVICES I N C O R P O R A T E D
SEP 24 1988
MILWAUKEE, WI 53203 PHONE: 414 . 291 . 0844 FAX: 414 . 291 . 0809
Premarket Notification Advanced Medical Devices, Inc. AMD Home Health Monitoring System
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The following information is submitted in accordance with the requirements of 21 CFR 807.92:
Contact Person: President
Date Prepared: December 18, 1995
Proprietary Name: AMD Home Health Monitoring System
Common/Usual Name: Self-Monitoring Blood Glucose Device
Classification Name: Test system, glucose (procode 75CGA)
Device Description/Intended Use: The AMD Home Health Monitoring System consists of the home-use, blood glucose meter, the AMD Home Health Glucose Monitor, with accessories, and the companion physician's monitoring device, the AMD PC Monitoring Station. vyhe AMD Home Health Glucose Monitor contains the glucose measurement technology of the MediSense Pen 2 device. MediSense Companion 2 Test Strips and Control Solutions are to be used with the AMD Home Health Glucose Monitor.
Health Glucose Monitor testing system has been The AMD Home developed to allow rapid measurement of blood glucose (D-glucose) by using an electrochemical detection technique'. This biosensor system employs a disposable dry reagent strip technology, based on
the glucose oxidase method for glucose determination. Each test strip features an electrode containing the enzyme glucose oxidase (Aspergillus niger). When a blood drop is applied to the target area of the test strip, the glucose oxidase catalyzes the oxidation of glucose in the drop to produce gluconic acid. During the reaction, electrons are transferred by way of an electrochemical mediator to the electrode surface. This in turn generates a current that is measured by the Home Health Glucose Monitor. The size of the current generated is proportional to the amount of glucose present in the blood drop, thus giving an accurate reading of the blood glucose concentration.
Cass, A.E.G. et al., Anal. Chem. 56 (1984) p.667. 2 Marks, V. & Dawson, A., B. Med. J. 1 (1965) p.293.
· Technology for Betier Health
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The computer-controlled Home Health Glucose Monitor facilitates efficient blood glucose testing and has an internal modem for the transmission of glucose test results to the remote AMD PC Monitoring Station. The AMD PC Monitoring Station is a personal computer-based system used in the clinical setting (e.g., physician's office, nurse's station, etc.) to receive and process blood glucose test data transmitted by the Home Health Glucose This device allows remote clinical review of test results Monitor. obtained in the patient's home.
Predicate Devices: The AMD Home Health Monitoring System I s substantially equivalent to the MediSense Pen 2 Blood Glucose Monitoring System, the Lifescan, Inc. ONE TOUCH® II Blood Glucose Monitoring System, and the BioStore Technologies BioStore" Diabetes Data Management System (intended for use with ONE TOUCH® II System).
Comparison: A chart comparing the AMD Predicate Home Health Monitoring System to the cited predicate devices, demonstrating substantial equivalence, is attached.
Submitted by:
Brian W Petersen President Advanced Medical Devices, Inc. 152 West Wisconsin Avenue Milwaukee, WI 53203
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DEVICE COMPARISON CHART
ﺃﺳﺴﺖ ﺃﻧ
| DeviceCharacteristic | AMD Home HealthMonitoring System | MediSense Pen 2 BloodGlucose Testing System | Lifescan ONE TOUCH IIBlood Glucose MonitoringSystem | *BioStore Technologies*BioStore L Data*Management System |
|---|---|---|---|---|
| Brief DeviceDescription | 1. Portable home-useblood glucose test meterwith test strips andcontrol solutions2. Dedicated clinical-usecomputer system forreceipt and management ofpatient blood glucosetest results by clinician | Portable home-use bloodglucose test meter withtest strips and controlsolutions | 1. Portable home-use blood*glucose test meter with *test strips and control *solutions *2. Dedicated home-use*computer software for*use by Lifescan ONE*TOUCH II device patients*for management of*personal blood glucose*test results and trans-*mission of test data to*remote clinical computer | |
| Indication ForUse | In vitro diagnostic usefor the quantitativemeasurement of glucose infresh capillary wholeblood | In vitro diagnostic usefor the quantitativemeasurement of glucose infresh capillary wholeblood | In vitro diagnostic use in monitoring whole bloodglucose in patients *diagnosed with diabetes *mellitus by conventional *means | * |
| Is Meter Hand-Held/Portable? | Yes | Yes | Yes | N/A* |
| DimensionsLength (in.):Width (in.):Height (in.): | 6.003.501.25 | 3.652.15.038 | 4.752.381.06 | N/A* |
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| DeviceCharacteristic | AMD Home HealthMonitoring System | MediSense Pen 2 BloodGlucose Testing System | Lifescan ONE TOUCH IIBlood Glucose MonitoringSystem | *BioStore Technologies*BioStore L Data*Management System |
|---|---|---|---|---|
| Number ofControlButtons | 4 | 1 | 1 | *N/A |
| Display Type | Alphanumeric, 2-line, 24-character liquid crystaldisplay (LCD) | Alphanumeric, 3-characterLCD | Alphanumeric, 6-characterLCD | *N/A |
| Power Source | Internal, rechargeablebatteries with externalDC power supply | Internal, non-replaceablebattery | Internal, replaceablebattery | *N/A |
| EstimatedBattery Life | 20 hours with fully-charged batteries | 4000 glucose tests | 1 year (@ 2 tests/day) | *N/A |
| Assay Range | 20-600 mg/dL(1.1-33.3 mmol/L) | 20-600 mg/Dl(1.1-33.3 mmol/L) | 0-600 mg/Dl(0-33.3 mmol/L) | *N/A |
| Sample Volume | 10-50 microliters | 10-50 microliters | Not specified | *N/A |
| OperatingTemp. Range | 64-86° F(18-30° C) | 64-86° F(18-30° C) | 59-95° F(15-35° C) | *N/A |
| OperatingHumidity Range | 20-80% RH | 20-80% RH | 0-90% RH | *N/A |
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DEVICE COMPARISON CHART (cont.)
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| DeviceCharacteristic | AMD Home HealthMonitoring System | MediSense Pen 2 BloodGlucose Testing System | Lifescan ONE TOUCH IIBlood Glucose MonitoringSystem | *BioStore Technologies*BioStore L Data*Management System |
|---|---|---|---|---|
| Test StripsSpecified | MediSense Companion 2Blood Glucose test Strips(private-labeled for AMD) | MediSense Companion 2Blood Glucose test Strips | Lifescan ONE TOUCH TestStrips | N/A* |
| ControlSolutionsSpecified | MediSense Companion 2HIGH and LOW ControlSolutions(private-labeled for AMD) | MediSense Companion 2HIGH and LOW ControlSolutions(private-labeled for AMD) | Lifescan ONE TOUCH NormalN/AGlucose Control Solution-Blue Formula | * |
and the comments of the comments of the comments of DEVICE COMPARISON CHART (cont.)
and the comments of the comments of
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§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.