(104 days)
Not Found
No
The summary describes a standard blood glucose monitoring system and does not mention any AI or ML components.
No
This device is a blood glucose monitoring system, used for the measurement of glucose in whole blood. It provides information for diagnosis and monitoring, but does not directly treat or prevent a disease.
Yes
Explanation: The device is described as a "Blood Glucose Monitoring System" which is used for the "measurement of glucose in whole blood." This measurement provides information used to manage diabetes, which falls under the definition of a diagnostic device by providing information crucial for diagnosis, monitoring, or treatment decisions.
No
The device description explicitly lists hardware components: a blood glucose monitor, test strips, and control solution. This indicates it is a physical medical device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the measurement of glucose in whole blood." Measuring substances in bodily fluids like blood in vitro (outside the body) is the core function of an IVD.
- Device Components: The system includes "Ascensia BREEZE®2 Blood Glucose Test Strips" and "Ascensia BREEZE®2 Control Solution." These are reagents and materials used to perform the diagnostic test on the blood sample, which are characteristic components of an IVD system.
- Testing of Biological Samples: The description details the collection of "capillary blood" for testing. This involves analyzing a biological sample in vitro.
- Comparison to Laboratory Analyzer: The performance studies compare the device's results to a "laboratory glucose analyzer," which is a standard IVD instrument.
Therefore, based on the provided information, the Ascensia BREEZE®2 Blood Glucose Monitoring System clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ascensia® BREEZE®2 Blood Glucose Monitoring System consisting of the Ascensia® BREEZE®2 Blood Glucose Meter, Ascensia® BREEZE®2 Reagent Strips and Ascensia® BREEZE®2 Control Solution is for the measurement of glucose in whole blood. The Ascensia® BREEZE®2 Blood Glucose Monitoring System allows the user an option to use the palm and forearm in addition to the fingertip (testing) to collect capillary blood for self-monitoring of blood glucose within certain conditions as explained in the labeling. Ascensia® BREEZE®2 Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes. Ascensia® Breeze®2 Blood Glucose Monitoring System is not for use with neonatal blood specimens. 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, JJX
Device Description
The Ascensia® BREEZE®2 Blood Glucose Monitoring System consists of: 1. Ascensia® BREEZE®2 Blood Glucose Monitor 2. Ascensia BREEZE®2 Blood Glucose Test Strips 3. Ascensia BREEZE®2 Control Solution
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Palm, forearm, fingertip
Indicated Patient Age Range
Not Found
Intended User / Care Setting
persons with diabetes, over-the-counter (OTC) device
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)
A validation of the Ascensia® BREEZE®2 Blood Glucose Monitoring System was performed in a clinical setting by persons with diabetes. The subject meter results for capillary blood samples were compared with BREEZE®2 results obtained by a healthcare professional and results of a laboratory glucose analyzer. The studies showed improved performance compared with past clinical studies of the original Ascensia® BREEZE® Blood Glucose Monitoring System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Ascensia BREEZE® Diabetes Care System, K024062
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.
Not Found
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.
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Bayer HealthCare Diabetes Care
Image /page/0/Picture/1 description: The image shows the Bayer company logo. The logo is a circle with the word "BAYER" written vertically in the center. The letters are arranged in a cross shape, with the "Y" in the middle. The logo is simple and recognizable, and it is often used on Bayer products and advertising materials.
NOV 2 1 2006
510(k) SUMMARY
Ascensia® BREEZE®2 Blood Glucose Monitoring System
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is K062347
| Prepared: | August 9, 2006 |
|---|---|
| Submitter: | Bayer HealthCare, Diabetes Care |
| Address: | Bayer HealthCare, Diabetes Care |
| 430 South Beiger Street | |
| Mishawaka, IN 46544 | |
| Phone (574) 256-7719; FAX (574) 256-3519 | |
| Contact: | Marc A. Henn, Regulatory Affairs Specialist |
| Device: | Trade/Proprietary Name: Ascensia® BREEZE®2 Blood |
| Glucose Monitoring System | |
| Common/Usual Name: | Blood Glucose Meter |
| Classification: | Division of Clinical Laboratory Devices |
| Panel - Clinical Chemistry and Toxicology | |
| Classification Code - 75 CGA, (Glucose Oxidase, Glucose) | |
| Predicate Device: | Ascensia BREEZE® Diabetes Care System, K024062 |
| Device Description: | The Ascensia® BREEZE®2 Blood Glucose Monitoring System |
| consists of: |
- Ascensia® BREEZE®2 Blood Glucose Monitor
- Ascensia BREEZE®2 Blood Glucose Test Strips
- Ascensia BREEZE®2 Control Solution |
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Page 2 of 2
| Intended Use: | The Ascensia® BREEZE®2 Blood Glucose Monitoring
System consisting of the Ascensia® BREEZE®2 Blood
Glucose Meter, Ascensia® BREEZE®2 Reagent Strips and
Ascensia® BREEZE®2 Control Solution is for the
measurement of glucose in whole blood. The Ascensia®
BREEZE®2 Blood Glucose Monitoring System allows the
user an option to use the palm and forearm in addition to the
fingertip (testing) to collect capillary blood for self-monitoring
of blood glucose within certain conditions as explained in the
labeling. Ascensia® BREEZE®2 Blood Glucose Monitoring
System is an over-the-counter (OTC) device used by
persons with diabetes. Ascensia® Breeze®2 Blood Glucose
Monitoring System is not for use with neonatal blood
specimens. The frequent monitoring of blood glucose is an
adjunct to the care of persons with diabetes. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics: | The Ascensia® BREEZE®2 Blood Glucose Monitoring
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. Blood glucose results are referenced to
plasma glucose. The system has a linearity response to
glucose from 20-600 mg/dL. |
| Assessment of
Performance: | A validation of the Ascensia® BREEZE®2 Blood Glucose
Monitoring System was performed in a clinical setting by
persons with diabetes. The subject meter results for
capillary blood samples were compared with BREEZE®2
results obtained by a healthcare professional and results of
a laboratory glucose analyzer. The studies showed
improved performance compared with past clinical studies of
the original Ascensia® BREEZE® Blood Glucose Monitoring
System. |
| Conclusion: | The results of the clinical evaluations of The Ascensia®
BREEZE®2 Blood Glucose Monitoring System demonstrated
that the device can produce blood glucose results that are
substantially equivalent to results obtained on the predicate
device. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the eagle in a circular fashion. The logo is rendered in black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Roger Sonnenburg Manager, Regulatory Affairs Bayer HealthCare, LLC 430 South Beiger St. Mishawaka, IN 46544
NOV 2 1 2006
Re: K062347
Trade/Device Name: Ascensia® BREEZE®2 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: November 15, 2006 Received: November 16, 2006
Dear Mr. Sonnenburg:
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 (240) 276-0484. 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/industry/support/index.html.
Sincerely vours.
Alberto Gutierrez
Alberto Gutierrez, Ph.D.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K062347
Device Name: Ascensia® BREEZE®2 Blood Glucose Monitoring System
Indications For Use: The Ascensia BREEZE®2 Blood Glucose Monitoring System consisting of the Ascensia "BREEZE"2 Blood Glucose Meter, Ascensia" BREEZE® Reagent Strips and Ascensia BREEZE®2 Control Solution is for the measurement of glucose in whole blood. The Ascensia BREEZE® 2 Gonton Solution in of the measurement of
glucose in whole blood. The Ascensia® BREEZE® 2 Blood Glucose Monitoring System allows the user an option to use the palm and forearm in addition to the fingertip (testing) to collect capillary blood for self-monitoring of blood glucose within certain conditions as explained in the labeling. Ascensia BREEZE®2 Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes. Ascensia BREEZE 2 Blood Glucose Monitoring System is not for use with neonatal blood specimens. 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 (21 CFR 801 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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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L062347