(21 days)
Not Found
No
The document describes a standard electrochemical blood glucose meter and test strips, with no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the equivalence to existing methods.
No
The device is a blood glucose meter used for monitoring, not for treating or preventing a disease. It provides information to adjunct the care of persons with diabetes, but it does not exert a therapeutic effect itself.
Yes
The device is used for the "measurement of glucose in whole blood" and "frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes," indicating its role in diagnosing and monitoring a medical condition.
No
The device description explicitly states that the system consists of a meter and test strips, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "measurement of glucose in whole blood from specimens taken from the fingers or an alternate puncture site." This involves testing a biological sample (blood) outside of the body to provide information about a person's health status (glucose levels related to diabetes).
- Device Description: The description mentions an "electrochemical method-based meter and dry reagent sensor (test strips)" designed for "testing glucose." This further confirms it's a system for analyzing a biological sample.
- Context of Use: It's used by "persons with diabetes and by healthcare professionals in home settings and in healthcare facilities" for "frequent monitoring of blood glucose," which is an "adjunct to the care of persons with diabetes." This clearly places it within the realm of medical diagnostics.
The core function of the device is to perform a test on a biological sample (blood) to diagnose or monitor a medical condition (diabetes), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingers or an alternate puncture site
Indicated Patient Age Range
Not Found
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
Not Found
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 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. These studies demonstrated that users can obtain blood glucose results that are substantially equivalent to current methods for blood glucose.
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.
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).
Not Found
§ 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.
0
DEC 22 2004
510(k) Summary of Safety and Effectiveness
Submitter Information
| Contact person: | George M. Tancos |
|---|---|
| Address: | 1884 Miles Avenue |
| Elkhart, 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 Chemistry |
| and Toxicology classification Code 75 CGA (Glucose Oxidase, | |
| Glucose) |
Predicate Device Information
| Name: | Ascensia ELITE™ Blood Glucose Meter |
|---|---|
| Manufacturer: | Bayer HealthCare LLC |
| 430 S. Bieger Street | |
| Mishawaka, 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.
1
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
2
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).
3
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
4
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