(130 days)
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No
The summary describes a standard blood glucose meter based on the Glucose Oxidase method, with no mention of AI or ML technologies in the device description, intended use, or performance studies.
No.
The device is a diagnostic tool for monitoring blood glucose levels, not a device that directly treats a condition. It provides information to aid in the care of persons with diabetes, but it does not provide therapy itself.
Yes
Explanation: The device measures blood glucose levels which is used as an "adjunct to the care of persons with diabetes," indicating its role in monitoring a medical condition for diagnostic and management purposes. It provides a "quantitative measurement of glucose" which directly relates to health status assessment.
No
The device description explicitly mentions "Blood Glucose Meters" and "Blood Glucose Test Strips," which are hardware components used for measuring glucose. The mechanism described involves an "electrode of the strip," further indicating a physical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is used for "self-monitoring of blood glucose as an adjunct to the care of persons with diabetes" and for "glucose in blood." This involves testing a biological sample (blood) outside of the body to provide information about a person's health status (glucose levels related to diabetes).
- Device Description: The description details how the device measures glucose in whole blood using a chemical reaction on a test strip. This is a classic method used in in vitro diagnostic devices.
- Sample Type: The device is designed to analyze "whole blood," "arterial blood specimens," and "neonatal specimens," all of which are biological samples.
- Purpose: The purpose is to provide a "quantitative measurement of glucose in whole blood," which is diagnostic information used in the management of diabetes.
The definition of an IVD generally includes 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. This device clearly fits that description.
N/A
Intended Use / Indications for Use
The GLUCOMETER ELITE Blood Glucose Test Systems are used for self-monitoring of blood glucose as an adjunct to the care of persons with diabetes.
The GLUCOMETER ELITE Blood Glucose Test Systems and the GLUCOMETER ELITE XL Blood Glucose Meter are over-the-counter (OTC) home testing systems for glucose in blood. These systems are for use by person with diabetes and by healthcare professionals in a home setting and in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
Product codes
CGA
Device Description
GLUCOMETER ELITE Blood Glucose Test Systems and the GLUCOMETER ELITE XL Blood Glucose Meter are over-the-counter home tests for glucose in blood. They are for use by persons with diabetes and by healthcare professional in home settings and in healthcare facilities. The GLUCOMETER ELITE Blood Glucose Test Strips are for use with the GLUCOMETER ELITE Blood Glucose Test family of meters.
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
persons with diabetes and by healthcare professional in home settings and in healthcare facilities.
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)
An evaluation was conducted at four clinical sites to demonstrate the performance of the GLUCOMETER ELITE XL Blood Glucose Meter for use with neonatal and arterial specimens. In addition, a separate clinical study was conducted to likewise demonstrate the efficacy of the GLUCOMETER ELITE Blood Glucose Test Systems for use with arterial samples. The results of the evaluation of the GLUCOMETER ELITE XL Blood Glucose Meter demonstrate the expanded use for neonatal and arterial specimens and that that the GLUCOMETER ELITE Blood Glucose Test Systems use of arterial specimens are suitable for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Prepared: | February 26, 1999 |
|---|---|
| Submitter: | Bayer Corporation, Business Group Diagnostics |
| Address: | 1884 Miles Avenue, P.O. Box 70 |
| Elkhart, IN 46515 | |
| (219) 262-6928 | |
| Contact: | George M. Tancos, R.A.C. |
| Manager, Regulatory Compliance | |
| Device: | Trade/Proprietary Name: |
| Glucometer® Elite® Blood Glucose Test Systems | |
| Glucometer® Elite® XL Blood Glucose Meter |
Common/Usual Name: Test for glucose in blood
Document Control Number: K99 0649 |
| Classification Name: | The GLUCOMETER ELITE Blood Glucose Test Systems and the
GLUCOMETER ELITE XL Blood Glucose Meter are used as a test for
glucose in blood. In 21 CFR 862.1345 a glucose test system is
classified as a Class II medical device. |
| Predicate Devices: | GLUCOMETER ENCORE® QA+ Blood Glucose Test System,
manufactured by Bayer Corporation |
| Device Description: | GLUCOMETER ELITE Blood Glucose Test Systems and the
GLUCOMETER ELITE XL Blood Glucose Meter are over-the-counter
home tests for glucose in blood. They are for use by persons with
diabetes and by healthcare professional in home settings and in
healthcare facilities. The GLUCOMETER ELITE Blood Glucose Test
Strips are for use with the GLUCOMETER ELITE Blood Glucose Test
family of meters. |
| Intended Use: | The GLUCOMETER ELITE Blood Glucose Test Systems are used for
self-monitoring of blood glucose as an adjunct to the care of persons
with diabetes |
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Technological Characteristics:
The GLUCOMETER ELITE and the GLUCOMETER ELITE XL Blood Glucose Meters are specific for glucose and have been referenced to give plasmalserum equivalent glucose results. The test systems provide a quantitative measurement of glucose in whole blood from 10 - 600 mg/dL (0.6 to 33.3 mmol/L). In addition, both the GLUCOMETER ELITE Blood Glucose Test Systems and the GLUCOMETER XL Blood Glucose Meter can be used with arterial blood specimens. The GLUCOMETER XL Blood Glucose Meter can be used with neonatal specimens.
The GLUCOMETER ELITE Blood Glucose Test Strips are based on the measurement of electrical potential caused by the reaction of glucose with the reagents (Glucose Oxidase method) on the electrode of the strip.
Assessment of Performance:
An evaluation was conducted at four clinical sites to demonstrate the performance of the GLUCOMETER ELITE XL Blood Glucose Meter for use with neonatal and arterial specimens. In addition, a separate clinical study was conducted to likewise demonstrate the efficacy of the GLUCOMETER ELITE Blood Glucose Test Systems for use with arterial samples.
Conclusion:
The results of the evaluation of the GLUCOMETER ELITE XL Blood Glucose Meter demonstrate the expanded use for neonatal and arterial specimens and that that the GLUCOMETER ELITE Blood Glucose Test Systems use of arterial specimens are suitable for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
JUL - 9 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. George M. Tancos, R.A.C. Manager, Regulatory Compliance Bayer Corporation Business Group Diagnostics 1884 Miles Avenue P.O. Box 70 Elkhart, Indiana 46515-0070
Re: K990649
Trade Name: Glucometer Elite Blood Glucose Test System Glucometer Elite XL Blood Glucose Meter Regulatory Class: II Product Code: CGA Dated: May 28, 1999 Received: June 2, 1999
Dear Mr. Tancos:
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 legally marketed predicate 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 of the Act. The general controls provisions 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours.
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name:
510(k) Number
ﺩﺭ ﺩﺭ ﺩﺭ ﺩﺍ
GLUCOMETER ELITE® Blood Glucose Test Systems GLUCOMETER ELITE® XL Blood Glucose Meter
The GLUCOMETER ELITE Blood Glucose Test Systems Indications for Use: and the GLUCOMETER ELITE XL Blood Glucose Meter are over-the-counter (OTC) home testing systems for glucose in blood. These systems are for use by person with diabetes and by healthcare professionals in a home setting and in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
4590649
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use √
(Optional Format 1-2-96)