(107 days)
Precision QID Blood Glucose Monitoring System, Glucometer Elite Diabetes Care System
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No
The description details a standard amperometric blood glucose meter which measures electrical current. There is no mention of AI or ML in the device description, intended use, or any other section.
No.
This device is an in vitro diagnostic (IVD) device used for monitoring blood glucose levels, not for treating a condition or administering therapy.
Yes
The device is intended for "quantitative measurement of glucose" which is a diagnostic purpose. It aids in monitoring the "effectiveness of diabetes control," further solidifying its role in diagnosing and managing a medical condition.
No
The device description explicitly states that the system comprises a glucose reagent test strip and an amperometric meter, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "The Elect System is intended for use outside the body (in vitro diagnostic use)..."
- Device Description: The description details how the system measures glucose in a blood sample outside the body using a reagent test strip and meter. This is the core characteristic of an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
75 CGA
Device 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.
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
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Indicated Patient Age Range
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Intended User / Care Setting
by diabetics at home
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)
Precision QID Blood Glucose Monitoring System, Glucometer Elite Diabetes Care System
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
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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.
1
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.