(84 days)
Not Found
No
The description focuses on an electrochemical method for glucose measurement and does not mention AI or ML.
No
The device is used for monitoring blood glucose levels to aid in the care of persons with diabetes, not for directly treating or curing a disease.
Yes
Explanation: The device is used for the "measurement of glucose in whole blood" to monitor blood glucose for persons with diabetes, which is a diagnostic purpose to provide information about a patient's health status.
No
The device description explicitly states it consists of a meter (hardware) and test strips (hardware/reagent), indicating it is not a software-only device.
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." This is a diagnostic measurement performed on a biological sample (blood) outside of the body.
- Device Description: It describes the device as using an "electrochemical method- based meter and dry reagent sensors (test strips) designed for testing glucose." This is a typical description of an in vitro diagnostic system.
- Sample Type: It specifies the use of "venous, and capillary whole blood samples." This confirms it's analyzing a biological sample.
The definition of an IVD is a medical device that is used to examine specimens, such as blood, tissue, or urine, taken from the human body to help detect, diagnose, monitor, or treat disease. The ASCENSIA BREEZE Blood Glucose Meter fits this definition perfectly.
N/A
Intended Use / Indications for Use
The ASCENSIA™ BREEZE™ Blood Glucose Meter is for the Self- Monitoring of Blood Glucose as an adjunct to the care of persons with diabetes.
The ASCENSIA BREEZE Blood Glucose Meter is used with the ASCENSIA™ AUTODISC™ Blood Glucose Test Strips and ASCENSIA™ AUTODISCTM CONTROLS for the measurement of glucose in whole blood. The ASCENSIA BREEZE Blood Glucose Meter is an Over-the-Counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings.
The ASCENSIA BREEZE Blood Glucose System is indicated for use with venous, and capillary whole blood samples drawn from the fingertip, palm, forearm, abdomen and thigh.
The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
Product codes
NBW, CGA
Device Description
The ASCENSIA™ BREEZE™ consists of an electrochemical method- based meter and dry reagent sensors (test strips) designed for testing glucose by persons with diabetes.
The electronics of the ASCENSIA™ BREEZE™ Blood Glucose Meter employs an amperometric glucose oxidase method to measure glucose in blood. It is conceptually similar as other blood glucose testing monitoring systems available for blood glucose testing. The Reagent Test Sensors are individually sealed in cartridges of ten sensors. Blood glucose results are reference to plasma glucose. The ASCENSIA™ BREEZE™ Blood Glucose Meter has a linear response to glucose from 10-600 mg/dL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, palm, forearm, abdomen and thigh
Indicated Patient Age Range
Not Found
Intended User / Care Setting
persons with diabetes and by healthcare professionals in home settings.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
An evaluation of the ASCENSIA™ BREEZE™ Blood Glucose Meter was conducted at five clinical sites to demonstrate the equivalence of the ASCENSIA™ BREEZE™ Blood glucose meter to the Ascensia DEX 2 Blood Glucose Meter, the predicate device, in the hands of diabetics.
The results of the evaluation of the ASCENSIA™ BREEZE™ Blood Glucose Meter demonstrate that the meter is equivalent in performance to the predicate device and suitable for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ASCENSIA™ DEX® 2
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Bayer Corporation, Business Group Diagnostics Ascensia TM Breeze™ Blood Glucose Meter Page 1 of 2
MAR 0 3 2003
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Prepared: | December 2, 2002 |
|---|---|
| Submitter: | Bayer Corporation, Business Group Diagnostics |
| Address: | 1884 Miles Avenue |
| P.O. Box 70 | |
| Elkhart, IN 46515 | |
| 574.262.6928 | |
| Contact: | George M. Tancos RAC |
| Manager, Regulatory Affairs | |
| Device: | |
| Trade/Proprietary Name: Ascensia ™ BREEZE™ Blood Glucose Meter | |
| Common/Usual Name: Test for glucose in whole blood -- Blood Glucose Meter | |
| Document Control Number: K024062 | |
| Classification Name: | Division of Clinical laboratory Devices |
| Panel -- Clinical Chemistry and Toxicology | |
| Classification Code -- 75 CGA (Glucose Oxidase, Glucose) | |
| In 21 CFR 862.1345, a glucose test system is classified as a Class II medical device. | |
| Predicate Devices: | ASCENSIA™ DEX® 2 |
| Manufactured by: Bayer Diagnostics, Mishawaka, IN | |
| Device Description: | The ASCENSIA™ BREEZE™ consists of an electrochemical method- based meter and dry reagent sensors (test strips) designed for testing glucose by persons with diabetes. |
| Intended Use: | The ASCENSIA™ BREEZE™ Blood glucose Meter is for the Self- Monitoring of Blood Glucose as an adjunct to the care of persons with diabetes. 1 |
1 "Consensus Statement on Self-Monitoring of Blood glucose," Diabetes Care, vol. 10, No. 1, January-February 1987, pages 95-99.
1
| Technological Characteristics: | The electronics of the ASCENSIA™ BREEZE™ Blood
Glucose Meter employs an amperometric glucose oxidase
method to measure glucose in blood. It is conceptually
similar as other blood glucose testing monitoring systems
available for blood glucose testing. The Reagent Test
Sensors are individually sealed in cartridges of ten
sensors. Blood glucose results are reference to plasma
glucose. The ASCENSIA™ BREEZE™ Blood Glucose
Meter has a linear response to glucose from 10-600
mg/dL. |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assessment of Performance: | An evaluation of the ASCENSIA™ BREEZE™ Blood
Glucose Meter was conducted at five clinical sites to
demonstrate the equivalence of the ASCENSIA™
BREEZE™ Blood glucose meter to the Ascensia DEX 2
Blood Glucose Meter, the predicate device, in the hands
of diabetics. |
| Conclusion: | The results of the evaluation of the ASCENSIA™
BREEZE™ Blood Glucose Meter demonstrate that the
meter is equivalent in performance to the predicate device
and suitable for its intended use. |
2
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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three horizontal lines representing its wings and wavy lines representing its tail feathers.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 0 3 2003
Mr. George M. Tancos Manager, Regulatory Affairs Bayer HealthCare LLC Diagnostics Division 1884 Miles Avenue P.O. Box 70 Elkhart, IN 46515-0070
Re: K024062
Trade/Device Name: ASCENSIA" BREEZE™ Blood Glucose Meter Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW: CGA Dated: February 18, 2003 Received: February 24, 2003
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 ger.eral controls provisions of the Act include requirements for annual registration. Iisting 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,
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
4
510(k) Number (if known): K024062
Device Name:
Indications for Use:
ASCENSIA™ BREEZE™ Blood Glucose Meter
The ASCENSIA BREEZE Blood Glucose Meter is used with the ASCENSIA™ AUTODISC™ Blood Glucose Test Strips and ASCENSIA™ AUTODISCTM CONTROLS for the measurement of glucose in whole blood. The ASCENSIA BREEZE Blood Glucose Meter is an Over-the-Counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings.
The ASCENSIA BREEZE Blood Glucose System is indicated for use with venous, and capillary whole blood samples drawn from the fingertip, palm, forearm, abdomen and thigh.
The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.
Sean Conroy
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number KE24062
(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)
$\varnothing R$
and
Over-The-Counter Use
(Optional Format 1-2-96)