(107 days)
The Elect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The Elect System is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor effectiveness of diabetes control.
The Elect Blood Glucose Monitoring System comprises a glucose reagent test strip, a amperometric meter and a quality control solution. The user inserts a test strip in the Elect Meter and applies a small drop of blood from a fingerstick to the sample point on the strip. The meter measures the electrical current that is generated which is proportional to the concentration of glucose present in the blood sample. The blood glucose result is displayed in 20 seconds. The system is calibrated to give a result equivalent to a plasma value, the measurement used by most clinical laboratories.
The provided text does not contain information about acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details for a study. The text primarily describes the "Elect Blood Glucose Monitoring System," its intended use, and its equivalence to other devices, focusing on product description rather than clinical study results or validation.
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Selfcare, Inc.
200 Prospect Street Waltham, Massachusetts 02154 Telephone 617 647 3900 Facsimile 617 647 3939
Page 66
Image /page/0/Picture/4 description: The image shows the word "selfcare" in a simple, sans-serif font. To the left of the word is a small graphic consisting of a circle above a square divided into four smaller squares. The graphic is black, and the word "selfcare" is also black.
EP 5 1988
510(k) Summary
Manufacturer:
Selfcare, Inc. 200 Prospect Street Waltham, MA 02154 Telephone: +617 647 3900 Fax: +617 647 3939
Contact Person: Carol Adiletto
Date: 20th May 1996
Device Name: Elect Blood Glucose Monitoring System
Common Name: Blood glucose meter and reagent test strips for blood glucose
Classification: Class II as per 21 CFR 862.1345. Glucose test system; Code 75 CGA (Glucose oxidase, glucose) Classification panel - clinical chemistry
Equivalent Devices: Precision QID Blood Glucose Monitoring System Glucometer Elite Diabetes Care System
Product Description
The Elect Blood Glucose Monitoring System comprises a glucose reagent test strip, a amperometric meter and a quality control solution. The user inserts a test strip in the Elect Meter and applies a small drop of blood from a fingerstick to the sample point on the strip. The meter measures the electrical current that is generated which is proportional to the concentration of glucose present in the blood sample. The blood glucose result is displayed in 20 seconds. The system is calibrated to give a result equivalent to a plasma value, the measurement used by most clinical laboratories.
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Intended Use:
The Elect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The Elect System is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor effectiveness of diabetes control.
Substantial Equivalence:
The Elect Blood Glucose Monitoring System is similar in technological characteristics, methodology and intended use to the predicate devices listed above. The Elect System utilizes similar biosensor methodology based on a standard enzymatic methodology employing the enzyme glucose oxidase coupled to an electrochemical detection system to measure glucose levels in whole blood.
§ 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.