(79 days)
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No
The summary describes a standard blood glucose monitoring system using test strips and a meter, with no mention of AI or ML capabilities.
No
The device measures glucose levels but does not provide therapy or treatment for diabetes; it is used for monitoring purposes.
Yes
The glucometer measures the glucose level in whole blood which is a diagnostic measurement for persons with diabetes.
No
The device description explicitly states it is a "Test Strip" used with "Blood Glucose Meters," indicating a physical, hardware component.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The text explicitly states the device is used "to measure the glucose level in whole blood." Measuring substances in bodily fluids like blood is a core function of IVDs.
- Device Description: It describes the system as an "over-the-counter (OTC) home test for glucose in blood." This further reinforces its use for diagnostic testing outside of a clinical laboratory setting, which is characteristic of many IVDs.
- Anatomical Site: The specified anatomical site is "whole blood," which is a biological sample used for in vitro testing.
The description clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
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® Test Strips are used with the GLUCOMETER ELITE® XL Blood Glucose Meter and the GLUCOMETER ELITE® Blood Glucose Test Systems to measure the glucose level in whole blood. The GLUCOMETER ELITE® XL and GLUCOMETER ELITE® Blood Glucose Systems are home-use (OTC) devices used by persons with diabetes, and by healthcare professionals in clinical settings for the self-monitoring of blood glucose and as an adjunct to the care of persons with diabetes.
Product codes (comma separated list FDA assigned to the subject device)
CGA
Device Description
The GLUCOMETER ELITE® Test Strips (Modified) are for use with the GLUCOMETER ELITE® family of blood glucose meters. The GLUCOMETER ELITE® Blood Glucose Test System is an over-the-counter (OTC) home test for glucose in blood. The system is used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.
The GLUCOMETER ELITE® Blood Glucose Test Systems are specific for glucose and have been referenced to give plasma/serum equivalent glucose results. These test systems provide a quantitative measurement of glucose in whole blood from 20 - 600 mg/dL (1.1 to 33.3 mmol/L).
The GLUCOMETER ELITE® 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.
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 professionals 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 in-house evaluation of the performance of the GLUCOMETER ELITE® Test Strips (Modified) was conducted to demonstrate and verify the performance with a 2 uL blood sample. The studies indicate that the GLUCOMETER ELITE® Test Strips with the reduced volume are suitable for their intended use.
The results of the evaluation of the GLUCOMETER ELITE® Test Strips (Modified) demonstrate satisfactory performance with 2 uL of specimen and are suitable for their intended use.
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.
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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.
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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).
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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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JUN 30 1999
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510(k) SAFETY AND EFFECTIVENESS SUMMARY
:
| Prepared: | April 9, 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: | |
| Common/Usual Name: | ||
| Document Control Number: | GLUCOMETER ELITE® Test Strips | |
| Test for glucose in blood | ||
| K991242 | ||
| Classification Name: | The GLUCOMETER ELITE® Test Strips and the GLUCOMETER | |
| ELITE® family of blood glucose meters are used to test for glucose in | ||
| blood. In 21 CFR 862.1345, a glucose test system is classified as a | ||
| Class II medical device. | ||
| Predicate Device: | GLUCOMETER ELITE® Test Strips | |
| Manufactured by: | The GLUCOMETER ELITE® Test Strips are produced by Arkray | |
| KDK Corporation of Kyoto, Japan. | ||
| Device Description: | The GLUCOMETER ELITE® Test Strips (Modified) are for use with | |
| the GLUCOMETER ELITE® family of blood glucose meters. The | ||
| GLUCOMETER ELITE® Blood Glucose Test System is an over-the- | ||
| counter (OTC) home test for glucose in blood. The system is used by | ||
| persons with diabetes and by healthcare professionals in home settings | ||
| and in healthcare facilities. | ||
| 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® Blood Glucose Test Systems are specific for glucose and have been referenced to give plasma/serum equivalent glucose results. These test systems provide a quantitative measurement of glucose in whole blood from 20 - 600 mg/dL (1.1 to 33.3 mmol/L).
The GLUCOMETER ELITE® 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 in-house evaluation of the performance of the GLUCOMETER ELITE® Test Strips (Modified) was conducted to demonstrate and verify the performance with a 2 uL blood sample. The studies indicate that the GLUCOMETER ELITE® Test Strips with the reduced volume are suitable for their intended use.
Conclusion:
The results of the evaluation of the GLUCOMETER ELITE® Test Strips (Modified) demonstrate satisfactory performance with 2 uL of specimen and are suitable for their intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a stylized caduceus, which is a symbol of medicine and health.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 30 1999
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: K991242
Trade Name: GLUCOMETER ELITE® Test Strips (Modified) Regulatory Class: II Product Code: CGA Dated: April 9, 1999 Received: April 12, 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
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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 Butman
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
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510(k) Number (if known): K99 (2 4)
GLUCOMETER ELITE® Test Strips Device Name:
Indications for Use: The GLUCOMETER ELITE® Test Strips are used with the GLUCOMETER ELITE® XL Blood Glucose Meter and the GLUCOMETER ELITE® Blood Glucose Test Systems to measure the glucose level in whole blood. The GLUCOMETER ELITE® XL and GLUCOMETER ELITE® Blood Glucose Systems are home-use (OTC) devices used by persons with diabetes, and by healthcare professionals in clinical settings for the self-monitoring of blood glucose and as an adjunct to the care of persons with diabetes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol C. Benson for Jean Cooper
(Division Sign Off)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K991242
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
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