(41 days)
Not Found
No
The description focuses on data transfer, viewing, and basic statistical analysis (trends, summaries) of blood glucose data. There is no mention of AI/ML terms or functionalities that would typically involve learning from data to make predictions, classifications, or generate insights beyond simple data visualization.
No
The device is a software program designed to transfer, view, and analyze blood glucose data, assisting in diabetes management, but it does not directly treat or diagnose a disease.
No
The device is a software program that allows for the transfer, viewing, and analysis of blood glucose data; it does not independently diagnose any condition but rather assists in managing diabetes by organizing existing blood glucose information.
Yes
The device is described as a "software program" that transfers and displays data from a blood glucose meter to a personal computer. While it interacts with a hardware device (the blood glucose meter) and requires a cable for data transfer, the device itself, as described in the summary, is the software application running on a personal computer. The description focuses solely on the software's functionality for data management and analysis, with no mention of hardware components being part of the submitted device.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The software is intended for transferring and analyzing blood glucose data obtained from blood glucose meters. Blood glucose meters are IVD devices used to measure glucose levels in blood, which is a biological specimen.
- Purpose: The purpose is to assist with reviewing and analyzing this blood glucose data to support effective diabetes management. This analysis of data derived from an IVD test falls under the scope of IVD devices.
- Predicate Device: The predicate device listed, K024234; Ascensia® Glucofacts® Data Management System, is also a data management system for blood glucose meters, further indicating that this type of software is considered an IVD.
While the software itself doesn't directly perform the diagnostic test (the blood glucose meter does that), it is an essential component in the process of managing diabetes based on the results of an IVD test. The analysis and presentation of the blood glucose data are crucial for interpreting the results and making decisions about diabetes management, which is a key aspect of in vitro diagnostics.
N/A
Intended Use / Indications for Use
GLUCOFACTS® Express Diabetes Management Software is an over-the-counter software program for use by health care professionals and patients with diabetes for transferring blood glucose data from a blood glucose meter to a personal computer for the purpose of viewing and printing reports that display blood glucose readings from Bayer's CONTOUR®, CONTOUR® TS, BREEZE®, and BREEZE®2 blood glucose meters.
Product codes
NBW, JQP
Device Description
This software application allows the transfer of blood glucose results, along with time, date, and certain data markers, from a Bayer blood glucose meter to a personal computer through the use of a serial or USB cable. Data analysis includes allowing the home-user or healthcare professional to view the data in five different ways: 1. Electronic logbook where all of the data can be seen 2. Glucose trend of the results by date 3. Daily blood glucose trend (standard day) 4. Weekly blood glucose trend (standard week) 5. Summary chart (histogram or pie chart)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals and patients with diabetes / home, healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The performance was assessed in a study that included 51 people - 43 lay users and eight healthcare professionals. The study showed that the program is easy to use and the results are understandable by the users.
Key Metrics
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Predicate Device(s)
Ascensia® Glucofacts® Data Management System, K024234
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
OCT 0 8 2008
Image /page/0/Picture/8 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" written twice, once horizontally and once vertically, intersecting at the "Y". The text is enclosed in a circle. The logo is in black and white.
510(k) SUMMARY
GLUCOFACTS® Express Data Management Software
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 | K082484 |
|---|---|
| Prepared: | August 25, 2008 |
| Submitter: | Bayer HealthCare Diabetes Care |
| Address: | 430 South Beiger Street |
| Mishawaka, IN 46544 | |
| Phone (574) 256-3441; FAX (574) 256-3519 | |
| Contact: | Roger Sonnenburg, Sr. Manager, Regulatory Affairs |
| Device: | Trade/Proprietary Name: GLUCOFACTS® Express Diabetes |
| Management Software | |
| Common/Usual Name: | Diabetes data management software program. |
| Classification: | Division of Clinical Laboratory Devices |
| Panel - Clinical Chemistry and Toxicology | |
| Classification Code - 75 NBW, JQP | |
| Predicate Device: | Ascensia® Glucofacts® Data Management System, |
| K024234 | |
| Device Description: | This software application allows the transfer of blood |
| glucose results, along with time, date, and certain data | |
| markers, from a Bayer blood glucose meter to a personal | |
| computer through the use of a serial or USB cable. Data | |
| analysis includes allowing the home-user or healthcare | |
| professional to view the data in five different ways: |
- Electronic logbook where all of the data can be seen
- Glucose trend of the results by date
- Daily blood glucose trend (standard day)
- Weekly blood glucose trend (standard week)
- Summary chart (histogram or pie chart) |
| Intended Use: | GLUCOFACTS® Express Diabetes Management Software is an
over-the-counter software program for use by health care |
1
| | professionals and patients with diabetes for transferring
blood glucose data from a blood glucose meter to a personal
computer for the purpose of viewing and printing reports that
display blood glucose readings from Bayer's CONTOUR®,
CONTOUR® TS, BREEZE®, and BREEZE®2 blood glucose
meters. |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological Characteristics: | There were no changes to the fundamental scientific
technology. |
| Comparison to
Predicate device: | GLUCOFACTS® Express Diabetes Management Software is
similar in function to the predicate device, Ascensia
Glucofacts Data Management System, K024234, but has
been updated to make it compatible with the most recent
Bayer blood glucose meters and to improve the ease of use. |
| Assessment of
Performance: | The performance was assessed in a study that included 51
people - 43 lay users and eight healthcare professionals.
The study showed that the program is easy to use and the
results are understandable by the users. |
| Conclusion: | The results of the verification and validation studies of the
GLUCOFACTS® Express Diabetes Management Software
demonstrated that the product is safe and effective in the
hands of lay users and healthcare professionals. The
product is substantially equivalent to the predicate device. |
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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 (HHS) of the United States. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 0 8 2008
Bayer Healthcare, LLC c/o Mr. Roger Sonnenburg 430 South Beiger St. Mishawaka, IN 46544
Re: K082486 Trade/Device Name: Glucofacts Express Diabetes Management Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, JQP Dated: September 16, 2008 Received: September 17, 2008
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).
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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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Féan M. Cooper, M.S., D.V.M. 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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Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: GLUCOFACTS® Express Diabetes Management Software
Indications For Use: GLUCOFACTS® Express Diabetes Management Software is an overthe-counter software program for use by persons with diabetes in the home and by healthcare professionals in healthcare facilities to assist with transferring blood glucose data from a blood glucose monitor to a personal computer to allow reviewing and analyzing the data to support effective diabetes management.
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 Device Evaluation (OIVD)
Division Sign-Off
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Office of In Vitm Diagnostic Device Evaluation and Safety