(244 days)
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No
The description details a standard electrochemical blood glucose monitoring system and a data transmission/monitoring system. There is no mention of AI or ML algorithms for data analysis, interpretation, or prediction.
No
The device is described as being for "in vitro diagnostic use for the quantitative measurement of glucose in fresh capillary whole blood," which indicates it is a diagnostic tool, not a therapeutic one. It measures a condition but does not treat it.
Yes
The device is explicitly stated for "In vitro diagnostic use for the quantitative measurement of glucose". The description details how it measures glucose in blood, which is a diagnostic measurement.
No
The device description explicitly details hardware components including a blood glucose meter, test strips, control solutions, and a PC monitoring station. While software is mentioned for data transmission and processing, the core functionality relies on physical hardware for glucose measurement.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "In vitro diagnostic use for the quantitative measurement of glucose in fresh capillary whole blood." This directly aligns with the definition of an IVD, which are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The description details how the device measures glucose in a blood sample using a chemical reaction and electrochemical detection. This process is performed outside of the body (in vitro) on a biological specimen (blood).
- Anatomical Site: The anatomical site is "fresh capillary whole blood," which is a specimen derived from the human body.
The fact that it's used in both home and clinical settings and involves data transmission doesn't change its fundamental nature as a device that performs diagnostic testing on a biological sample outside the body.
N/A
Intended Use / Indications for 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.
In vitro diagnostic use for the quantitative measurement of glucose in fresh capillary whole blood
Product codes (comma separated list FDA assigned to the subject device)
75CGA
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
fresh capillary whole blood
Indicated Patient Age Range
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Intended User / Care Setting
Home for patient self-monitoring, clinical setting (e.g., physician's office, nurse's station, etc.) for review by clinician.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The AMD Home Health Monitoring System is 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).
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
DEVICE COMPARISON CHART
ﺃﺳﺴﺖ ﺃﻧ
| Device
Characteristic | AMD Home Health
Monitoring System | MediSense Pen 2 Blood
Glucose Testing System | Lifescan ONE TOUCH II
Blood Glucose Monitoring
System | *BioStore Technologies
*BioStore L Data
*Management System |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Brief Device
Description | 1. Portable home-use
blood glucose test meter
with test strips and
control solutions
- Dedicated clinical-use
computer system for
receipt and management of
patient blood glucose
test results by clinician | Portable home-use blood
glucose test meter with
test strips and control
solutions | 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 For
Use | In vitro diagnostic use
for the quantitative
measurement of glucose in
fresh capillary whole
blood | In vitro diagnostic use
for the quantitative
measurement of glucose in
fresh capillary whole
blood | In vitro diagnostic use *
in monitoring whole blood
glucose in patients *
diagnosed with diabetes *
mellitus by conventional *
means | *
*
-
|
| Is Meter Hand-
Held/Portable? | Yes | Yes | Yes | *N/A
*
-
|
| Dimensions
Length (in.):
Width (in.):
Height (in.): | 6.00
3.50
1.25 | 3.65
2.15
.038 | 4.75
2.38
1.06 | *N/A
*
-
|
3
| Device
Characteristic | AMD Home Health
Monitoring System | MediSense Pen 2 Blood
Glucose Testing System | Lifescan ONE TOUCH II
Blood Glucose Monitoring
System | *BioStore Technologies
*BioStore L Data
*Management System |
|---------------------------------|------------------------------------------------------------------------|-------------------------------------------------|-------------------------------------------------------------|------------------------------------------------------------------|
| Number of
Control
Buttons | 4 | 1 | 1 | *N/A |
| Display Type | Alphanumeric, 2-line, 24-
character liquid crystal
display (LCD) | Alphanumeric, 3-character
LCD | Alphanumeric, 6-character
LCD | *N/A |
| Power Source | Internal, rechargeable
batteries with external
DC power supply | Internal, non-replaceable
battery | Internal, replaceable
battery | *N/A |
| Estimated
Battery 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 |
| Operating
Temp. Range | 64-86° F
(18-30° C) | 64-86° F
(18-30° C) | 59-95° F
(15-35° C) | *N/A |
| Operating
Humidity Range | 20-80% RH | 20-80% RH | 0-90% RH | *N/A |
.
DEVICE COMPARISON CHART (cont.)
人———
.
4
| Device
Characteristic | AMD Home Health
Monitoring System | MediSense Pen 2 Blood
Glucose Testing System | Lifescan ONE TOUCH II
Blood Glucose Monitoring
System | *BioStore Technologies
*BioStore L Data
*Management System |
|-----------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------|
| Test Strips
Specified | MediSense Companion 2
Blood Glucose test Strips
(private-labeled for AMD) | MediSense Companion 2
Blood Glucose test Strips | Lifescan ONE TOUCH Test
Strips | *N/A
*
-
|
| Control
Solutions
Specified | MediSense Companion 2
HIGH and LOW Control
Solutions
(private-labeled for AMD) | MediSense Companion 2
HIGH and LOW Control
Solutions
(private-labeled for AMD) | Lifescan ONE TOUCH NormalN/A
Glucose 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
ﻣﺴﺎﺀ ﺍ