(26 days)
The ASCENSIA™ DEX®2 Blood Glucose Meter is used with ASCENSIA™AUTODISC™ Blood Glucose Test Strips GLUCOMETER® DEX® Test Sensor and Controls for the measurement of glucose in whole blood. The ASCENSIA™ DEX®2 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™ DEX®2 Diabetes Care 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.
The provided text is a 510(k) summary for the ASCENSIA™ DEX® 2 Diabetes Care System, a blood glucose meter. It describes the device, its intended use, technological characteristics, and notes that performance data was collected. However, it does not provide specific acceptance criteria or detailed results of a study that proves the device meets those criteria, nor does it contain information about sample sizes for test or training sets, expert qualifications, or adjudication methods.
The document makes general statements about performance but lacks the quantitative data and study design details requested in the prompt.
Therefore, many sections of your request cannot be fulfilled based on the
provided text.
Here is what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance:
- "The studies demonstrated that users can obtain blood glucose results that are substantially equivalent to current methods for blood glucose."
- "The System has a linear response to glucose from 10-600 mg/dL."
- "The results of in-house and clinical evaluations of the ASCENSIA™ DEX® 2 Diabetes Care System demonstrate that the device is equivalent in performance to the predicate devices and suitable of its intended use."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: "in-house and in clinical settings" - no country of origin is mentioned. The description "An evaluation...was studied..." suggests prospective data collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified. The text mentions studies "by healthcare professionals and by persons with diabetes," but does not detail the role of experts in establishing ground truth or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
5. 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
- Not applicable. This is a blood glucose meter, not an AI-assisted diagnostic imaging device that uses "human readers." No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device itself is a standalone blood glucose meter. Its performance would be inherently "standalone" in the context of its direct measurement capabilities. The text states: "The ASCENSIA™ DEX® 2 Diabetes Care System consists of an electrochemical method-based meter and dry reagent sensor (test strips) designed for testing glucose..." The performance evaluation appears to be of the device's accuracy in measuring glucose values, which is its standalone function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The text states, "Blood glucose results are referenced to plasma glucose." This implies that a laboratory reference method for plasma glucose was used as the ground truth.
8. The sample size for the training set
- Not specified. (The document doesn't explicitly refer to "training sets" as it's not a machine learning device in the modern sense, but rather a traditional medical device.)
9. How the ground truth for the training set was established
- Not specified. (See point 8.)
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NOV 2 0 2002
Page 1 of 2
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: | 574.262.6945 |
| E-mail: | george.tancos.b@bayer.com |
| Date Prepared: | October 11, 2002 |
Device Information
| Proprietary Name: | ASCENSIA™ DEX® 2 Diabetes Care System |
|---|---|
| Common Name: | Blood Glucose Meter |
| Classification: | Division of clinical laboratory Devices Panel --- ClinicalChemistry and Toxicology classification Code 75 CGA (GlucoseOxidase, Glucose) |
Predicate Device Information
| Name: | ASCENSIA™ DEX® 2 Blood Glucose Meter |
|---|---|
| Manufacturer: | Bayer Diagnostics430 S. Beiger StreetMishawaka, In 46544 |
510(k) Number: K020210
Device Description
The ASCENSIA™ DEX®2 Diabetes Care 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.
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Statement of Intended Use:
The ASCENSIA™ DEX®2 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™ DEX®2 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.
Performance Data:
An evaluation of the ASCENSIA™ DEX® 2 Diabetes Care System was studied in-house and in clinical settings by healthcare professionals and by persons with diabetes. The studies demonstrated that users can obtain blood glucose results that are substantially equivalent to current methods for blood glucose.
Conclusion:
The results of in-house and clinical evaluations of the ASCENSIA™ DEX® 2 Diabetes Care System demonstrate that the device is equivalent in performance to the predicate devices and suitable of its intended use.
"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 USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three parallel lines above them, resembling an abstract representation of a bird or eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. George M. Tancos R.A.C. Manager Regulatory Affairs Bayer Corporation 1884 Miles Avenue P.O. Box 70 Elkhart, IN 46515-0070
Re: K023584 .
Trade/Device Name: ASCENSIA™ DEX®2 Diabetes Care System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW; CGA Dated: October 22, 2002 Received: October 25, 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.
NOV 2 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 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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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). 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director 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): KOB3584
Device Name:
ASCENSIA™ DEX®2 Diabetes Care System
Indications for Use:
The ASCENSIA™ DEX®2 Blood Glucose Meter is used with ASCENSIA™AUTODISC™ Blood Glucose Test Strips GLUCOMETER® DEX® Test Sensor and Controls for the measurement of glucose in whole blood. The ASCENSIA™ DEX®2 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.
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number ـــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K623594
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use V
§ 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.