(114 days)
Not Found
No
The description details a standard amperometric blood glucose meter which measures electrical current proportional to glucose concentration. There is no mention of AI/ML in the intended use, device description, or specific sections for AI/ML details.
No
Explanation: A therapeutic device is used to treat a disease or condition. This device is a diagnostic tool used to measure blood glucose levels, which aids in monitoring diabetes control but does not directly treat the condition.
Yes
The device is intended for the quantitative measurement of glucose in blood and is described as an "aid to monitor effectiveness of diabetes control," which falls under diagnostic purposes. It also explicitly states "in vitro diagnostic use."
No
The device description explicitly states that the system comprises a glucose reagent test strip, an amperometric meter, and a quality control solution, all of which are hardware components.
Yes, based on the provided information, the Elect II Blood Glucose Monitoring System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "The Elect II 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 function of an in vitro diagnostic device.
The definition of an IVD device is a medical device that is used to examine specimens, such as blood, urine, or tissue, that are taken from the human body to provide information for diagnosis, monitoring, or screening. The Elect II system fits this definition perfectly.
N/A
Intended Use / Indications for Use
The Elect II Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The Elect II 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
CGA
Device Description
The Elect II 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 II 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 15 seconds. The system is calibrated to give a result equivalent to a plasma value, the measurement used by most clinical laboratories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
by diabetics at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
1970707
JUN 2 0 1997
510(k) Summary
)
توندي المنتدى التقارير المنتخب المنتخب المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتقل المنتق
| Manufacturer: | Selfcare, Inc.
200 Prospect Street
Waltham, MA 02154
Telephone: (617) 647-3900
Fax: (617) 647-3939 | | |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Carol Adiletto | | |
| Date: | February 25, 1997 | | |
| Device Name: | Elect II Blood Glucose Monitoring System | | |
| Common Name: | Blood glucose meter and reagent test strips for blood
glucose | | |
| Classification (meter/strips): | Class II as per 21 CFR Section 862.1345
Glucose test system; Code 75 CGA
(glucose oxidase, glucose)
Classification panel - Clinical Chemistry | | |
| Classification (control): | Class I as per 21 CFR Section 862.1660,
Code 75 JJX (singe analyte control) | | |
| Classification (lancets): | Class I as per 21 CFR Section 878.4800,
Code 79 FMK (lancet, blood) | | |
| Performance Standards: | None established under section 514 | | |
| Equivalent Devices: | Elect Blood Glucose Monitoring System
(Selfcare, Inc. K961985)
Precision Q.I.D. Blood Glucose Monitoring System
(Medisense, Inc. K945887) | | |
1
Product Description:
The Elect II 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 II 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 15 seconds. The system is calibrated to give a result equivalent to a plasma value, the measurement used by most clinical laboratories.
Intended Use:
The Elect II Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The Elect II 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 II Blood Glucose Monitoring System is similar in technological characteristics, methodology and intended use to the predicate devices listed above. The Elect II 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.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
1997 0 7 NUNT
Carol A. Adiletto, M.S. Clinical Director SelfCare, Inc. 200 Prospect Street Waltham, Massachusetts 02154
K970707 Re : Elect II Blood Glucose Monitoring System Requlatory Class: II Product Code: CGA Dated: February 25, 1997 Received: February 26, 1997
Dear Ms. Adiletto:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Selfcare, Inc. Sellcare, Inc.
Elect II Blood Glucose Monitoring System 510(k) Submission
Indications for Use Form
510(k) Number (if known):
Elect II Blood Glucose Monitoring System Device Name:
Indication for Use:
The Elect II Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. the quartitution is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor the effectiveness of diabetes control.
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number. | K97087 |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation
Prescription Use
Over-The-Counter Use_