(128 days)
The GLUCOMETER Elite XL Blood Glucose Meter is used with GLUCOMETER Elite® Test Strips and Controls for the measurement of glucose in whole blood. The GLUCOMETER Elite System is an Over-the-Counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
The GLUCOMETER Elite XL System consists of an electrochemical method-based meter and dry reagent sensor (test strips) designed for testing glucose by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the GLUCOMETER Elite® XL Blood Glucose Meter:
It's important to note that the provided text is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing exhaustive detail on the full validation study. Therefore, some information, particularly granular details on acceptance criteria and specific performance metrics, is limited.
Acceptance Criteria and Reported Device Performance
The core acceptance criterion for the GLUCOMETER Elite XL Blood Glucose Meter, as presented in this 510(k) summary, is its equivalence in performance to the predicate device, the GLUCOMETER Elite Blood Glucose Meter. The summary explicitly states: "The results of the evaluation of the GLUCOMETER Elite XL Blood Glucose Meter demonstrate that the new meter is equivalent in performance to the predicate device and suitable for its intended use."
Specific numerical acceptance criteria and their corresponding reported performance values are not explicitly detailed in the provided document. The summary focuses on the comparative nature of the study.
Study Details
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A table of acceptance criteria and the reported device performance:
Acceptance Criteria Reported Device Performance Equivalence in performance to the predicate device (GLUCOMETER Elite Blood Glucose Meter) The GLUCOMETER Elite® XL Blood Glucose Meter was demonstrated to be equivalent in performance to the predicate device. The algorithm was modified to provide greater accuracy at low glucose concentrations, suggesting an improvement in this specific aspect while maintaining overall equivalence. -
Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions the evaluation was "conducted at two clinical sites."
- Data Provenance: The study was "conducted at two clinical sites," implying a prospective study. The country of origin is not specified, but the submitter is Bayer Corporation, located in Elkhart, IN, USA, suggesting the clinical sites were likely in the USA. The study involved "diabetics and healthcare professionals," indicating real-world usage.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the given text. For a blood glucose meter, ground truth is typically established using a laboratory reference method, not by human experts.
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Adjudication method for the test set:
- This information is not provided in the given text.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, this was not a MRMC comparative effectiveness study in the context of AI. This device is a blood glucose meter, which is a standalone measurement device, not an AI-assisted diagnostic tool that human readers would interact with. The study compared the new meter to a predicate meter.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the primary study described is a standalone performance assessment of the GLUCOMETER Elite XL Blood Glucose Meter itself. The device measures blood glucose directly, and its performance (accuracy, precision) is evaluated intrinsically, rather than in conjunction with human interpretation of its outputs. The evaluation demonstrated the equivalence of the meter to the predicate device.
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The type of ground truth used:
- The type of ground truth is implied to be a laboratory reference method for blood glucose measurement. While not explicitly stated, clinical evaluations of blood glucose meters always compare the device's readings against a highly accurate and precise laboratory standard (e.g., hexokinase method, glucose oxidase method on a central lab analyzer). The predicate device's performance would also have been established against such a standard.
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The sample size for the training set:
- This information is not applicable and therefore not provided. The GLUCOMETER Elite XL Blood Glucose Meter is an electrochemical method-based meter. While it has an "algorithm modified to provide greater accuracy at low glucose concentrations," this typically refers to a fixed set of mathematical operations or calibrations rather than a machine learning algorithm requiring a separate "training set" in the modern AI sense. Devices like this are calibrated and validated, not "trained" with a large dataset in the way an AI model is.
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How the ground truth for the training set was established:
- This information is not applicable as there is no mention of a "training set" in the context of AI for this device. The "algorithm modification" would have been developed and refined using standard engineering and calibration techniques, likely with reference to precise lab measurements of glucose at various concentrations.
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Bayer Corporation, Business Group Diagnostics GLUCOMETER Elite® XL Blood Glucose Meter S&E Summary Page 1 of 2
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Prepared: | November 6, 1998 |
|---|---|
| Submitter: | Bayer Corporation, Business Group Diagnostics |
| Address: | 1884 Miles Avenue, P.O. Box 70Elkhart, IN 46515(219) 262-6928 |
| Contact: | George M. Tancos, RACManager, Regulatory Compliance |
| Device: | Trade/Proprietary Name: GLUCOMETER Elite® XL BloodGlucose MeterCommon/Usual Name: Blood Glucose MeterDocument Control Number: K98 |
| Classification: | Division of Clinical Laboratory DevicesPanel - Clinical Chemistry and ToxicologyClassification Code – 75CGA (Glucose Oxidase, Glucose) |
| Predicate Devices: | GLUCOMETER Elite® Blood Glucose MeterManufactured by KDK Corporation of Kyoto, Japan |
| Device Description: | The GLUCOMETER Elite XL System consists of anelectrochemical method-based meter and dry reagent sensor (teststrips) designed for testing glucose by persons with diabetes or byhealthcare professionals in the home or in healthcare facilities. |
| Intended Use: | The GLUCOMETER Elite XL Blood Glucose Meter is for the SelfMonitoring of Blood Glucose as an adjunct to the care of personwith diabetes.¹ |
1 "Consensus Statement on Self-Monitoring of Blood Glucose, " Diabetes Care, Vol. 10, No. 1, January-February 1987, pp. 95.99
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Bayer Corporation, Business Group Diagnostics GLUCOMETER Elite® XL Blood Glucose Meter S&E Summary Page 2 of 2
Technological Characteristics:
The GLUCOMETER Elite XL Blood Glucose Meter has internal engineering design changes. The memory features have been ' expanded to include storing up to 120 test results, registering the time and date a test is performed. This data can then be used to provide a 14-day blood glucose average. In addition, the GLUCOMETER Elite XL Blood Glucose Meter has the capability to down load stored data to a computer system which can electronically summarize data in a logbook report, graph, or chart via the WinGlucofacts™ Diabetes Management Software. The algorithm was modified to provide greater accuracy at low glucose concentrations. Cosmetic changes to the case include a rounded top, a larger display window, and a button to access the setup menu and memory functions.
Assessment of Performance:
An evaluation of the GLUCOMETER Elite XL Blood Glucose Meter was conducted at two clinical sites to demonstrate the equivalence of the new meter to the currently used GLUCOMETER Elite Blood Glucose Meter, the predicate device, in the hands of diabetics and healthcare professionals.
Conclusion:
The results of the evaluation of the GLUCOMETER Elite XL Blood Glucose Meter demonstrate that the new meter is equivalent in performance to the predicate device and suitable for its intended use.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure. The figure is composed of three overlapping profiles facing to the right. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 8 1999
Mr. George M. Tancos, RAC Manager, Regulatory Compliance Bayer Corporation Business Group Diagnostics 1884 Miles Avenue P.O. Box 70 Elkhart, Indiana 46515
Re: K984006
Trade Name: GLUCOMETER Elite® XL Blood Glucose Meter Regulatory Class: II Product Code: CGA Dated: February 9, 1999 Received: February 10, 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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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 Sutman
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): K9840000
Device Name:
Indications for Use:
GLUCOMETER Elite® XL Blood Glucose Meter
The GLUCOMETER Elite XL Blood Glucose Meter is used with GLUCOMETER Elite® Test Strips and Controls for the measurement of glucose in whole blood. The GLUCOMETER Elite System is an Over-the-Counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
flin Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K984006
(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)
Over-The-Counter Use √
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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.