(235 days)
Not Found
No
The description focuses on data transfer, organization, tracking, and trending, with no mention of AI or ML algorithms for analysis or interpretation.
No
The software is used for transferring and organizing data, not for providing medical treatment or medication dosage recommendations, which would be characteristic of a therapeutic device.
No
Explanation: The device is software that downloads and organizes glucose data from a glucose meter, allowing for tracking and trending. It explicitly states, "The software does not recommend any medical treatment or medication dosage level," indicating it does not diagnose or recommend treatment, but rather helps manage data.
Yes
The device is described as "software accessory" and "software" throughout the summary, and its function is data transfer and organization from a separate hardware device (glucose meter) to a computer. It does not include or require any specific hardware components beyond a standard computer and connection cables.
Based on the provided information, the On Call® Plus Diabetes Software is not an IVD (In Vitro Diagnostic) device itself.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The On Call® Plus Diabetes Software does not perform any such examination of specimens.
- The software's function is to receive, organize, and display data that has already been generated by an IVD device (the On Call® Plus Glucose Meter). It acts as a data management and visualization tool.
- The intended use explicitly states it's an "optional software accessory" for transferring and organizing data from the glucose meter. It does not perform the diagnostic test itself.
- The software does not recommend medical treatment or medication dosage. This further reinforces that it's not making diagnostic or treatment decisions based on analyzing specimens.
While the software is used in conjunction with an IVD device (the glucose meter) and is intended to aid in the management of diabetes, its function is data handling and presentation, not the in vitro diagnostic testing itself.
N/A
Intended Use / Indications for Use
The On Call® Plus Diabetes Software is an optional software accessory to be used with the On Call® Plus Glucose Meters for transferring data to a computer and organizing it in tables and graphs to be used at home and by health care professionals. The software does not recommend any medical treatment or medication dosage level.
Product codes (comma separated list FDA assigned to the subject device)
NBW, JQP
Device Description
The On Call® Plus Diabetes Monitoring Software is for downloading glucose data from the On Call Plus meter to a PC through an USB to RS232 TTL level cable or RS232 to RS232 TTL level cable, with tracking and trending capabilities of glucose measurements.
The Diabetes Data Management Software is intended to be used in a clinical setting with multiple patients by a healthcare professional, or directly by the patient.
The user has the choice to install either a personal "Home" or "Professional" version. In the "Home" version, glucose results are assembled for a single user. In the "Professional" version, the software user can configure a database with multiple providers and patients. The number of providers, patients and data points is limited only by the computer's capabilities.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home and by health care professionals.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance characteristics of the On Call® Plus Diabetes Monitoring Software were evaluated by performing the software validation test.
Clinical studies were conducted with lay persons using the On Call® Plus Diabetes Monitoring Software to demonstrate that the intended user can easily operate the software features including Installing the software, transferring meter data to the computer, changing settings, setting up providers and patients, using passwords, viewing and printing reports and uninstalling the software.
Study results indicate that non-professional, inexperienced lay persons were able to operate the software and obtain glucose trending reports. In addition, the participating lay persons were questioned and responded as satisfied with the ease of operation by following the User's Manual and the overall performance of the On Call® Plus Diabetes Monitoring Software.
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.
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).
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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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ડ. 510(k) Summary
The summary of the 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 ________________________________________________________________________________________________________________________________________________
Submitters Identification:
ACON Laboratories, Inc. 10125 Mesa Rim Road San Diego, California 92121
Tel: 858-875-8019 Fax: 858-875-8099
Date prepared: May 7th, 2010
Contact Person:
Richard Lenart Regulatory Affairs Manager
Proprietary Name of the Device:
On Call® Plus Diabetes Monitoring Software
Common name:
Diabetes Software
Classification Name:
Class I §862.2100 Calculator/data processing module for clinical use. Class II §862.1345 Glucose Test System (To be manufactured and marketed for consumer home and professional use)
Predicate Device:
Glucofacts® Deluxe Diabetes Management Systems Bayer Healthcare 430 South Beiger Street, Mishawaka, IN 46544 510(k) K091820
1
Device name: On Call® Plus Diabetes Monitoring Software
| Proprietary Name | Classification | Product
Code | Description | Common Name |
|-----------------------------------------------------|------------------------|-----------------|-----------------------------------------------------|----------------------|
| On Call® Plus
Diabetes
Monitoring
Software | §862.1345
§862.2100 | NBW,
JQP | System, Test,
Blood Glucose,
Over The Counter | Diabetes
Software |
Description:
The On Call® Plus Diabetes Monitoring Software is for downloading glucose data from the On Call Plus meter to a PC through an USB to RS232 TTL level cable or RS232 to RS232 TTL level cable, with tracking and trending capabilities of glucose measurements.
The Diabetes Data Management Software is intended to be used in a clinical setting with multiple patients by a healthcare professional, or directly by the patient.
The user has the choice to install either a personal "Home" or "Professional" version. In the "Home" version, glucose results are assembled for a single user. In the "Professional" version, the software user can configure a database with multiple providers and patients. The number of providers, patients and data points is limited only by the computer's capabilities.
Intended Use:
The On Call® Plus Diabetes Software is an optional software accessory to be used with the On Call® Plus Glucose Meters for transferring data to a computer and organizing it in tables and graphs to be used at home and by health care professionals. The software does not recommend any medical treatment or medication dosage level.
Technological Characteristics:
| Feature | Specification |
|---|---|
| System Requirements | Pentium or equivalent processor, USB or RS-232 9-pin serial port |
| 128 MB memory, 70 MB hard drive space, minimum 800 x 600 | |
| display, CD-ROM drive | |
| Operating Systems | Microsoft Windows 2000, XP Home/Professional, Vista, windows 7 |
| Reports, Charts and Graphs | Data list report, line, bar and pie charts, average day line chart, |
| average day/week bar charts. | |
| Glucose Units of Measure | millimoles per liter (mmol/L) or milligrams per deciliter (mg/dL) |
| Users | Multiple users and patients limited only by the capabilities of the |
| computer being used | |
| Passwords | Create databases that are password protected |
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| Delete Memory | comparent proposes and proposations and proposes and charges of confessional con-
Can delete patients, providers, databases and data stored in meters |
|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| www.comment.com/sports/collection/com/com/demail/collection/close- | |
Comparison to Predicate Device:
The On Call® Plus Diabetes monitoring Software is substantially equivalent to
Glucofacts® Deluxe Diabetes Management Softwa
| Features | On Call® Plus Diabetes Monitoring
Software | Glucofacts® Deluxe Diabetes
Management Software
(K091820) | | | |
|------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------|--|--|--|
| Similarities | | | | | |
| COM Ports scan | Automatic scan for connected ports | Same | | | |
| Multiple patients | Can list data for multiple patients | Same | | | |
| Data list/ Summary
report | List of all readings inside selected
time frame | Same | | | |
| Reports and charts | Data List, Log Book report, Standard
Day report, Trend report, Pie charts | Same | | | |
| Target levels | High, low, hyper and hypo glucose
target levels can be changed | Same | | | |
| Time periods | Daily time periods can be changed | Same | | | |
| Units of measure | Can choose either mmol/L or mg/dL | Same | | | |
| Data Base | Can Set up multiple patient data bases | Same | | | |
| Differences | |||||
|---|---|---|---|---|---|
| Change Meter | |||||
| settings | Does not allow change to meter | ||||
| settings through the Diabetes | |||||
| Monitoring Software | Allows target range, alarm sounds | ||||
| and optional level changes to | |||||
| supported meters through the | |||||
| Management Software | |||||
| Operating System | Microsoft Windows 2000, XP | ||||
| Home/Professional, Vista, windows 7 | Microsoft Windows XP, Vista or | ||||
| Mac OS 10.5.7 or later (Mac is only | |||||
| an option with the Contour USB | |||||
| meter) | |||||
| Associate a meter to | |||||
| a person | No association | Software can be set to recognize | |||
| meters and associate them to | |||||
| specific patients | |||||
| Standard week | |||||
| report | No Standard Week report | A graph that displays all readings | |||
| by day overlapping all the days on | |||||
| a one week graph | |||||
| Average Week | A bar graph that averages all | ||||
| readings for each day by day of the | |||||
| week, Sunday through Saturday and | |||||
| before and after meals. | No average week report | ||||
| Average Day | A bar graph that averages all readings | ||||
| for each day by time slot and before | |||||
| and after meals. | No average day report | ||||
| Password | Allows providers accounts to be | ||||
| password protected | Does not have password protection | ||||
| on the software | |||||
| Providers | Allows for multiple providers each | ||||
| with their own data base of patients | Does not have providers but does | ||||
| allow for multiple databases |
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Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows: '
The performance characteristics of the On Call® Plus Diabetes Monitoring Software were evaluated by performing the software validation test. Guidance documents included "Content of Premarket Submissions for Software Contained in Medical Devices -Guidance for Industry and FDA Staff." Compliance to applicable voluntary standards includes EN 62366:2008, "Medical devices, Application of usability engineering to medical devices" and EN 62304:2006 "Medical device software, Software life cycle processes."
Discussion of Clinical Tests Performed:
Clinical studies were conducted with lay persons using the On Call® Plus Diabetes Monitoring Software to demonstrate that the intended user can easily operate the software features including Installing the software, transferring meter data to the computer, changing settings, setting up providers and patients, using passwords, viewing and printing reports and uninstalling the software.
Study results indicate that non-professional, inexperienced lay persons were able to operate the software and obtain glucose trending reports. In addition, the participating lay persons were questioned and responded as satisfied with the ease of operation by following the User's Manual and the overall performance of the On Call® Plus Diabetes Monitoring Software.
Conclusion:
The laboratory testing and clinical study results demonstrate that the On Call® Plus Diabetes Monitoring Software is safe, effective and easy-to-use. It demonstrates that the On Call® Plus Diabetes Monitoring Software meets all the validation and clinical requirements and is substantially equivalent to the Baver Glucofacts Deluxe Diabetes Management Software sold on the U.S. market (K091820).
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three wing-like shapes, positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" and is arranged around the circle's perimeter.
Acon Laboratories, Inc. c/o Richard Lenart 10125 Mesa Rim Rd., San Diego, CA 92121
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
JAN 07 2011
Re: K101371
Trade/Device Name: On Call Plus Diabetes Monitoring Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: II Product Code: NBW. JOP Dated: December 3, 2010 Received: December, 6, 2010
Dear: Mr. Lenart:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrio's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
CA
Courtney C. Harper, Ph.D. 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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4. INDICATIONS FOR USE
510(k) number (if known): K101371
JAN - 7 2011
Device Name: On Call® Plus Diabetes Monitoring Software
Indications for Use:
The On Call® Plus Diabetes Software is an optional software accessory to be used with the On Call® Plus Glucose Meter for transferring data to a computer and organizing it in tables and graphs to be used at home and by health care professionals. The software does not recommend any medical treatment or medication dosage level.
Prescription Use (Part 21 CFR 801 Subpart D) C) .
AND/OR
Over-The-Counter Use_ X (21 CFR 807 Subpart
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OIVD)
Division Sign-Off
Office of In Vitro Dlagnostic Device Evaluation and Safety Page I of _ l _ _ l
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510(k) K10137