(21 days)
The Ascensia ELITE™ Blood Glucose Meter is used with Ascensia ELITE™ Blood Glucose Test Strips, and Ascensia ELITE™ Controls for the measurement of glucose in whole blood from specimens taken from the fingers or an alternate puncture site within certain conditions. The Ascensia ELITE™ Diabetes Care 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 Ascensia ELITE™ Diabetes Care System consists of an electrochemical methodbased 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 regarding the Ascensia ELITE™ Blood Glucose Meter, structured according to your requested information.
Please note that the provided 510(k) summary is very high-level and does not contain the detailed performance data or study methodology that would typically be required to fully answer all your questions. The document explicitly states: "An evaluation of the Ascensia ELITE™ Care System was studied to verify and validate that the microprocessor change did not adversely affect or change the performance characteristics of the system." This suggests the primary goal of the submission was to demonstrate that a change to an existing device did not degrade performance, and thus much of the detailed original performance data might be referenced from the predicate device submissions (K020208/K964630) which are not included here. Therefore, many sections will indicate "Not Specified in the document."
Acceptance Criteria and Device Performance for Ascensia ELITE™ Blood Glucose Meter
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Linear response to glucose (range) | 20-600 mg/dL |
| Result display time | 30 seconds |
| Substantial equivalence to current methods for blood glucose (predicate device K020208/K964630) | "demonstrated that users can obtain blood glucose results that are substantially equivalent to current methods for blood glucose." |
| Performance not adversely affected by microprocessor change | "demonstrated that the microprocessor change did not adversely affect or change the performance characteristics of the system." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the document.
- Data Provenance: Not specified in the document (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not specified in the document. The general nature of blood glucose meter evaluations typically involves comparison to a laboratory reference method, not individual expert assessment of each reading.
4. Adjudication Method for the Test Set
- Not specified in the document. Given the nature of blood glucose measurement, a consensus-based adjudication method for individual readings is unlikely to be applicable. The "ground truth" would generally be a precise laboratory measurement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size (AI vs. Without AI Assistance)
- Not applicable. This device is a standalone blood glucose meter and does not involve AI assistance or human reader interpretation for diagnostic purposes in the way an imaging AI system would.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, this is an inherent aspect of the device. The "algorithm" (the meter's electrochemical measurement and calculation) generates a result directly. The performance evaluation would be of this standalone measurement capability against a reference method. The document states: "An evaluation of the Ascensia ELITE™ Care System was studied to verify and validate that the microprocessor change did not adversely affect or change the performance characteristics of the system." This refers to the standalone performance of the device.
7. The Type of Ground Truth Used
- The document states that "Blood glucose results are referenced to plasma glucose." This strongly implies that the ground truth for performance evaluation was established using a laboratory reference method for plasma glucose. This is the standard for blood glucose meter validation.
8. The Sample Size for the Training Set
- Not applicable/Not specified. Blood glucose meters are not typically "trained" in the machine learning sense with a distinct training set. Their performance is based on the underlying chemical and electrical engineering principles, validated against reference measurements.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not specified for the reasons stated in point 8.
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DEC 22 2004
510(k) Summary of Safety and Effectiveness
Submitter Information
| Contact person: | George M. Tancos |
|---|---|
| Address: | 1884 Miles AvenueElkhart, IN 46515 |
| Phone: | 574.262.6928 |
| FAX: | 574.262.4945 |
| E-mail: | george.tancos.b@bayer.com |
| Date Prepared: | November 30, 2004 |
Device Information
| Proprietary Name: | Ascensia ELITE™ Blood Glucose Meter |
|---|---|
| Common Name: | Blood Glucose Meter |
| Classification: | Division of clinical laboratory Devices Panel --- Clinical Chemistryand Toxicology classification Code 75 CGA (Glucose Oxidase,Glucose) |
Predicate Device Information
| Name: | Ascensia ELITE™ Blood Glucose Meter |
|---|---|
| Manufacturer: | Bayer HealthCare LLC430 S. Bieger StreetMishawaka, In 46544 |
| 510(k) Number(s): | K020208/K964630 |
Device Description
The Ascensia ELITE™ Diabetes Care System consists of an electrochemical methodbased 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.
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Statement of Intended Use:
The Ascensia ELITE™ Diabetes Care System is for the Self-Monitoring of Blood Glucose as an adjunct to the care of person with diabetes. 4
Summary of Technological Characteristics:
The Ascensia ELITE™ Diabetes Care System is based on an electrode sensor technology. Capillary action at the end of the Test Strip draws a small amount of blood into the reaction chamber and a reading is displayed in 30 seconds. The Test Strips are foiled and available in packages of 25, 50, or 100 counts. Blood glucose results are referenced to plasma glucose. The System has a linear response to glucose from 20-600 mg/dL.
Performance Data:
An evaluation of the Ascensia ELITE™ Diabetes Care System was studied to verify and validate that the microprocessor change did not adversely affect or change the performance characteristics of the system. These studies demonstrated that users can obtain blood glucose results that are substantially equivalent to current methods for blood glucose.
Conclusion:
The results of verification and validation evaluations of the Ascensia ELITE™ Diabetes Care System demonstrate that the device is equivalent in performance to the predicate device and suitable of its intended use.
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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and flowing design.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 2 2004
Mr. George M. Tancos Manager, Regulatory Affairs Bayer HealthCare LLC Diabetes Care Division 1884 Miles Avenue, PO Box 70 Elkhart, IN 46514-0070
Re: K043311
Ito 150 Fri Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: November 30, 2004 Received: December 1, 2004
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.
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/cdrh/dsma/dsmamain.html.
Sincerely yours.
Cornelia B. Parks
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): KO4331 |
Device Name:
Indications for Use:
Ascensia ELITE™ Diabetes Care System
The Ascensia ELITE™ Blood Glucose Meter is used with Ascensia ELITE™ Blood Glucose Test Strips, and Ascensia ELITE™ Controls for the measurement of glucose in whole blood from specimens taken from the fingers or an alternate puncture site within certain conditions. The Ascensia ELITE™ Diabetes Care 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.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use -XX-(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safet
510(k) K043311
§ 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.