(98 days)
The GLUCOMETER® DEX® 2 Blood Glucose Meter and the GLUCOMETER® DEX® Test Sensors are used to measure the glucose levels in whole blood from specimens taken from the fingers or an alternate puncture sites within cartain conditions. The GLUCOMETER® DEX® Diabetes Care System is an over-the-counter (OTC) device used by persons with diabetes in a home setting and by healthcare professionals in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
The GLUCOMETER® DEX® Diabetes Care System includes: GLUCOMETER® DEX® 2 Blood Glucose Meter GLUCOMTER® DEX® Test Sensors This Diabetes Care System consists of an electrochemical methodbased meter and dry reagent sensor (test strips) designed for testing blood glucose by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
The provided text describes the GLUCOMETER® DEX® Diabetes Care System, an electrochemical method-based meter and dry reagent sensor (test strips) designed for testing blood glucose. The submission states that the device is conceptually the same as other blood glucose monitoring products. The acceptance criteria and the study conducted are described as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| The device can produce blood glucose results from alternate puncture sites that are equivalent to blood glucose results from fingersticks within certain conditions explained in product labeling. | The studies demonstrated that users can obtain blood glucose results from alternate puncture sites that are equivalent to blood glucose results from fingersticks within certain conditions. |
| The System has a linear response to glucose from 10-600 mg/dL. | The System has a linear response to glucose from 10-600 mg/dL. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated, but the summary mentions "an evaluation... conducted in a clinical setting by persons with diabetes." It does not provide specific numbers for participants or tests performed.
- Data Provenance: The study was conducted in a "clinical setting." No specific country of origin is mentioned, but the submitter is based in Elkhart, IN, USA. The study appears to be a prospective clinical evaluation as it involves actual users, "persons with diabetes," and healthcare professionals using the device in a clinical setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the summary. The "ground truth" seems to be established by comparison with "blood glucose results from fingersticks," implying a reference method, but the qualifications of individuals performing or interpreting these reference tests are not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the summary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The study described focuses on the equivalence of alternate puncture site results to fingerstick results, rather than comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is a blood glucose meter system used by individuals with diabetes or healthcare professionals. Therefore, its performance intrinsically involves "human-in-the-loop." A standalone algorithm-only performance study, as typically understood for imaging or diagnostic algorithms, is not applicable or described for this type of device. The "performance" refers to the accuracy of the device itself in measuring glucose.
7. Type of Ground Truth Used
The ground truth used for comparison was "blood glucose results from fingersticks." This implies that fingerstick blood glucose measurements, likely obtained using a recognized reference method or another validated blood glucose meter, served as the standard against which alternate puncture site measurements were compared.
8. Sample Size for the Training Set
This information is not applicable. The GLUCOMETER® DEX® Diabetes Care System is described as an "electrochemical method-based meter" employing an "amperometric glucose oxidase method." This is a biochemical measurement system, not a machine learning or AI-driven device that requires a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no mention of a training set for an AI/machine learning model. The device's underlying technology is based on electrochemical principles.
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Baver Dias GLUCOMETER® DEX® Diabetes Care Sy S&E Summary Page 1 of 2
510(k) SAFETY AND EFFECTIVENESS SUMMARY Prepared: January 18, 2002 Bayer Diagnostics Submitter: 1884 Miles Avenue, P.O. Box 70 Address: Elkhart, IN 46515 (574) 262-6928 George M. Tancos, RAC Contact: Manager, Regulatory Compliance GLUCOMETER® DEX® Diabetes Care Device: Trade/Proprietary Name: System Common/Usual Name: Blood Glucose Meter Blood Glucose Test Sensor Document Control Number: K02 O21 O Classification: Division of Clinical Laboratory Devices Panel - Clinical Chemistry and Toxicology Classification Code - 75GA (Glucose Oxidase, Glucose) Predicate Devices: GLUCOMETER® DEX® Blood Glucose Meter GLUCOMETER® DEX® Test Sensors Device Description: The GLUCOMETER® DEX® Diabetes Care System includes: GLUCOMETER® DEX® 2 Blood Glucose Meter GLUCOMTER® DEX® Test Sensors This Diabetes Care System consists of an electrochemical methodbased meter and dry reagent sensor (test strips) designed for testing blood glucose by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.
APR 3 0 2002
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Bayer Diagnostics GLUCOMETER® DEX® Diabetes Care System S&E Summary Page 2 of 2
Intended Use:
The GLUCOMETER® DEX® Diabetes Care System is used for the Self-Monitoring of Blood Glucose as an adjunct to the care of persons with diabetes.1
Technological Characteristics:
The GLUCOMETER® DEX® Diabetes Care System employs an amperometric glucose oxidase method to measure glucose in blood. It is conceptually the same as other blood glucose monitoring products available for blood glucose testing. The test sensor discs are individually sealed in a package of ten. Blood glucose results are referenced to plasma glucose. The System has a linear response to glucose from 10-600 mg/dL.
Assessment of Performance:
An evaluation of the GLUCOMETER® DEX® Diabetes Care System was conducted in a clinical setting by persons with diabetes. The studies demonstrated that users can obtain blood glucose results from alternate puncture sites that are equivalent to blood glucose results from fingersticks within certain conditions explained in the product labeling.
Conclusion:
The results of clinical evaluations of the GLUCOMETER® DEX® Diabetes Care System demonstrate that the device can produce blood glucose results from alternate puncture sites that are equivalent to blood glucose results from fingersticks within certain conditions explained in product labeling.
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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DEPARTMENT OF HEALTH & HUMAN SERVICES :
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black.
Public Health Service
Food and Drug Administ 2098 Gaither Road Rockville MD 20850
Mr. George M. Tancos Manager, Regulatory Compliance Bayer Corporation 1884 Miles Avenue P.O. Box 70 Elkhart, IN 46515-0070
K020210 Re:
Trade/Device Name: GLUCOMETER®DEX Diabetes Care System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: March 28, 2002 Received: March 29, 2002
Dear Mr. Tancos:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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.
PR 3 0 2002
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/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): K020210
Device Name:
Indications for Use:
GLUCOMETER® DEX® Diabetes Care System
The GLUCOMETER® DEX® 2 Blood Glucose Meter and the GLUCOMETER® DEX® Test Sensors are used to measure the glucose levels in whole blood from specimens taken from the fingers or an alternate puncture sites within cartain conditions. The GLUCOMETER® DEX® Diabetes Care System is an over-the-counter (OTC) device used by persons with diabetes in a home setting and by healthcare professionals 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 Laboratoi
510(k) Number K020210
(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
§ 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.