(186 days)
Freestyle Insulinx, Precision Xtra™, Freestyle Freedom, Freestyle 5, Freestyle Flash, Freestyle Lite, Freestyle Freedom Lite
No
The description focuses on data upload, organization, and graphical presentation, with no mention of AI/ML terms or capabilities like prediction, pattern recognition beyond simple display, or learning from data. The performance studies are focused on software functionality and human factors, not AI/ML model performance.
No.
The software is intended for data review and analysis to support diabetes management, not for direct therapeutic intervention or diagnosis.
No
The document explicitly states that "Freestyle Auto-Assist software is not intended for the diagnosis of or screening for diabetes mellitus." It is intended for review, analysis, and evaluation of information.
Yes
The device is described as a "software application" and a "stand-alone software program" that runs on a user's computer. While it interacts with hardware (glucose meters and a computer), the device itself is the software component for data management and analysis.
Based on the provided information, the FreeStyle Auto-Assist Software Version 2.0 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states that the software is "not intended for the diagnosis of or screening for diabetes mellitus." IVD devices are specifically designed for the diagnosis, monitoring, or screening of diseases or conditions using samples from the human body.
- Function: The software's primary function is to aid in the review, analysis, and evaluation of data already collected by compatible meters. It organizes and presents this data in a user-friendly format (graphs, reports) to support diabetes management. It does not perform any tests on biological samples itself.
- Device Description: The description reinforces that it's a software application for uploading, organizing, and presenting data from meters. It doesn't describe any components or processes related to analyzing biological samples.
While the software uses data from IVD devices (the blood glucose and ketone meters), the software itself is a data management and analysis tool, not an IVD.
N/A
Intended Use / Indications for Use
The Freestyle Auto-Assist Software Version 2.0 is intended for use by people with diabetes to aid in the review, analysis and evaluation of information such as blood glucose results. blood ketone test results and other data uploaded from a compatible meter. such as insulin doses and exercise data from the Freestyle Insulinx meter, in support of an effective diabetes health management program.
Freestyle Auto-Assist software is not intended for the diagnosis of or screening for diabetes mellitus.
Product codes
NBW, JQP
Device Description
Freestyle Auto-Assist Software Version 2.0 is a software application that allows people with diabetes to upload data from Freestyle Insulinx, Precision Xtra™, Freestyle Freedom. Freestyle 5. Freestyle Flash. Freestyle Lite and Freestyle Freedom Lite Blood Glucose Monitoring Systems into FreeStyle Auto-Assist Software Version 2.0, where users may review blood glucose and other data in a number of different graphical presentations.
It is a stand-alone software program available for download to a home user's computer via download from an Abbott Diabetes Care (ADC) website or if a previous version of Auto-Assist software is installed on the computer, through a notification from the ADC Informatics Upgrade Server. The software will also be available to users via a CD-ROM.
FreeStyle Auto-Assist Software Version 2.0 is intended for use in home settings by lay users to upload data from compatible meters to a patient's computer. Users can use FreeStyle Auto-Assist Software Version 2.0 to upload glucose data and other information (user entered notes, sound notifications, reminders) from their glucose meter and manually enter personal notes, such as insulin, meals, and exercise data. The software provides graphs and other software tools to help organize and present glucose readings. insulin dosage, and other diabetes-related factors that have been uploaded from devices or manually entered.
FreeStyle Auto-Assist Software Version 2.0 organizes the data in a presentable manner that is easy to view and interact with (save, generate reports and print reports). Communication with the devices is achieved through a serial cable or serial/USB adapter cable.
The following functions are supported by FreeStyle Auto-Assist Software Version 2.0:
Data Upload .
FreeStyle Auto-Assist Software Version 2.0 retrieves each blood glucose test result or ketone result, and the date and time of the measurement, from the memory of recognized, compatible meters. It retrieves the data through either a Serial or Serial/USB cable, a Strip Port /USB cable, or a Micro-USB/USB cable. These data are viewable through and used by FreeStyle Auto-Assist Software Version 2.0 to generate reports. Additionally these data may be exported to a text file (.txt) and saved.
Data Entry .
Through the FreeStyle Auto-Assist Software Version 2.0 user interface additional personal notes, such as insulin, meals, and exercise data may be added to the logged data collected from the meter.
. Data Access
Data from the compatible meter can be displayed through the software or saved in text file format (.txt).
. Meter Settings Backup
For compatible meters, the meter settings listed in the table below are retrieved from the meter. The meter settings can be saved to the computer by selecting the backup meter file option.
Report Generation .
For compatible meters, the following reports are available: Snapshot, Modal Day, Logbook, Glucose Average, Daily Statistics, Meal Event Averages.
Report Printout .
Once generated, reports can be printed through an available printer or saved to the computer in portable document file (.pdf) format.
. Date/Time Synchronization
While connected to the FreeStyle Auto-Assist Software Version 2.0, the user may synchronize the date and time of the meter with the computer date and time if selected.
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
people with diabetes / 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)
Software Verification and Validation: FreeStyle Auto-Assist Software Version 2.0 was validated pursuant to the moderate level of concern requirements. Design validation testing confirmed that the software performs according to the stated intended use. Software evaluation consisted of functional testing and code inspections which was performed on FreeStyle Auto-Assist Software Version 2.0's design verification. The software was developed in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) and General Principles of Software Validation 1/11/2002: Final Guidance for Industry and FDA Staff, where applicable and appropriate.
Human Factors study: A total of 35 participants of typical computer experience (used computer at least 4 times per week) and ages (age range 18 to 66 years old) that would be expected to use diabetes data management software were enrolled in the Human Factors study conducted for FreeStyle Auto-Assist Software Version 2.0. All of the study participants had diabetes: 13 were Type 1 and 22 were Type 2. As part of the study, users installed the software on their test computer desktop and launched the software. Task 1 required the subjects to install the software. Task 2 required subjects to upload meter data and create and print reports, and Task 3 required subjects to save previously generated reports. Users were given either of two meters (16 were tested using Freestyle Freedom Lite meters and 18 with Precision Xtra meters), and were assessed on their ability to upload meter data, create and print reports, and save reports to their desktop. Meters were preloaded with data such as blood glucose or ketone results, based on the compatible meters, and users created reports and graphs using this stored data. Stored data was automatically uploaded from a compatible meter when it was connected to a computer running FreeStyle Auto-Assist Software Version 2.0.
Key results: These studies demonstrated that the FreeStyle Auto-Assist Software Version 2.0 performed according to the specifications and the intended use. Based on the study, 32 subjects were able to successfully create and view reports, and the data in these reports matched the stored data in 100% of cases.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Abbott Diabetes Care Inc. 1360 South Loop Rd.
1360 South Loop Rd. Alameda, CA 94502
t 510-749-5400 f 510-864-4791
12308
APR 0 5 2013
510(k) Summary
According to the requirements of 21 CFR §807.92, the following information provides detail for a determination
General Information
| Submitter Information | Abbott Diabetes Care Inc. |
|---|---|
| 1360 South Loop Road | |
| Alameda, CA 94502 | |
| Contact Person: | David Lambert |
| Senior Regulatory Affairs Specialist | |
| Telephone No. | 510-749-5105 |
| Fax No. | 510 864-4791 |
| Date Prepared | February 1, 2013 |
| Device Information: | |
| Proprietary Name: | Freestyle Auto-Assist Software Version 2.0 |
| Common Name: | i) System, Test, Blood Glucose, |
| Over the counter, | |
| ii) Calculator/data processing | |
| module, for clinical use | |
| Classification Name | i) Glucose test system. (21 CFR |
| 862.1345, Product Code NBW) | |
| ii) Calculator/data processing module, | |
| for clinical use. (21 CFR 862.2100, Product | |
| Code JQP) | |
| Predicate Device: | CoPilot™ Health Management System |
| Cleared under K062770 | |
| Legal Manufacturer: | Abbott Diabetes Care Ltd |
| Range Road | |
| Witney | |
| Oxon | |
| OX29 0YL | |
| UK |
Image /page/0/Picture/8 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a stylized letter "a" on the left, followed by the text "Abbott" in a bold, sans-serif font on the right. Below "Abbott" is the text "Diabetes Care" in a smaller, less bold font.
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Indication For Use
The Freestyle Auto-Assist Software Version 2.0 is intended for use by people with diabetes to aid in the review, analysis and evaluation of information such as blood glucose results. blood ketone test results and other data uploaded from a compatible meter. such as insulin doses and exercise data from the Freestyle Insulinx meter, in support of an effective diabetes health management program.
Freestyle Auto-Assist software is not intended for the diagnosis of or screening for diabetes mellitus.
Device Description and Technological Characteristics
Freestyle Auto-Assist Software Version 2.0 is a software application that allows people with diabetes to upload data from Freestyle Insulinx, Precision Xtra™, Freestyle Freedom. Freestyle 5. Freestyle Flash. Freestyle Lite and Freestyle Freedom Lite Blood Glucose Monitoring Systems into FreeStyle Auto-Assist Software Version 2.0, where users may review blood glucose and other data in a number of different graphical presentations.
It is a stand-alone software program available for download to a home user's computer via download from an Abbott Diabetes Care (ADC) website or if a previous version of Auto-Assist software is installed on the computer, through a notification from the ADC Informatics Upgrade Server. The software will also be available to users via a CD-ROM.
FreeStyle Auto-Assist Software Version 2.0 is intended for use in home settings by lay users to upload data from compatible meters to a patient's computer. Users can use FreeStyle Auto-Assist Software Version 2.0 to upload glucose data and other information (user entered notes, sound notifications, reminders) from their glucose meter and manually enter personal notes, such as insulin, meals, and exercise data. The software provides graphs and other software tools to help organize and present glucose readings. insulin dosage, and other diabetes-related factors that have been uploaded from devices or manually entered.
FreeStyle Auto-Assist Software Version 2.0 organizes the data in a presentable manner that is easy to view and interact with (save, generate reports and print reports). Communication with the devices is achieved through a serial cable or serial/USB adapter cable.
The following functions are supported by FreeStyle Auto-Assist Software Version 2.0:
Data Upload .
FreeStyle Auto-Assist Software Version 2.0 retrieves each blood glucose test result or ketone result, and the date and time of the measurement, from the memory of recognized, compatible meters. It retrieves the data through either a
Image /page/1/Picture/11 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a stylized letter "A" on the left, followed by the words "Abbott" and "Diabetes Care" stacked on top of each other on the right. The text is in a bold, sans-serif font.
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Serial or Serial/USB cable, a Strip Port /USB cable, or a Micro-USB/USB cable. These data are viewable through and used by FreeStyle Auto-Assist Software Version 2.0 to generate reports. Additionally these data may be exported to a text file (.txt) and saved.
Data Entry .
Through the FreeStyle Auto-Assist Software Version 2.0 user interface additional personal notes, such as insulin, meals, and exercise data may be added to the logged data collected from the meter.
. Data Access
Data from the compatible meter can be displayed through the software or saved in text file format (.txt).
. Meter Settings Backup
For compatible meters, the meter settings listed in the table below are retrieved from the meter. The meter settings can be saved to the computer by selecting the backup meter file option.
| Table 1. Meter Settings | |
|---|---|
| Setting | |
| Patient Name | |
| Patient ID | |
| Date/Time | |
| Clock Mode | |
| Button Sound | |
| Sound Notifications | |
| Notes | |
| Reminders (Alarms) | |
| Weekly Messages | |
| Personalization Image | |
| Insulin units (manual entry 1 or $\frac{1}{2}$ unit) |
Table 1. Meter Settings
Report Generation .
For compatible meters, the following reports are available:
| Report Type | Description |
|---|---|
| Snapshot | General summary of data for the specified date |
| range. It also includes notes that inform the | |
| patient and their healthcare professional about | |
| important trends in blood glucose data by | |
| putting the data into words | |
| Modal Day | Shows the daily pattern of glucose levels over |
| the specified date range. |
Table 2. Auto-Assist 2.0 System Reports
Image /page/2/Picture/13 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a stylized letter "a" on the left, followed by the words "Abbott" on the top line and "Diabetes Care" on the bottom line. The text is in a bold, sans-serif font.
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| Report Type | Description |
|---|---|
| Logbook | Displays a table of glucose, carbohydrate, and insulin values associated with each time period over the specified date range. |
| Glucose Average | Separates all glucose readings over the specified date range into pre-meal and post-meal groupings and averages the values for each group. |
| Daily Statistics | Provides an overview of blood glucose, and other values such as ketones and insulin, over the date range if supported by your meter. |
| Meal Event Averages | |
| (Compatible meters only) | Compares the before-meal and after-meal blood glucose levels for the morning, midday and evening over the specified date range. This report also shows before and after meal averages, and insulin and carbohydrate intake for meals. |
Table 2. Auto-Assist 2.0 System Reports
Report Printout .
Once generated, reports can be printed through an available printer or saved to the computer in portable document file (.pdf) format.
. Date/Time Synchronization
While connected to the FreeStyle Auto-Assist Software Version 2.0, the user may synchronize the date and time of the meter with the computer date and time if selected.
Comparison to Predicate Device
Freestyle Auto-Assist Software Version 2.0 has similar data and graphic presentation capabilities to the predicate device, CoPilot™ Health Management System, cleared under K062770.
The similarities between FreeStyle Auto-Assist Software Version 2.0 and the predicate are highlighted below:
| Feature | Predicate CoPilot Diabetes
Data Management System | Proposed
Auto-Assist™ Software
Version 2.0 |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Editing of Patient
Data | Does not allow user to edit data
retrieved from a meter | Same |
| Feature | Predicate CoPilot Diabetes
Data Management System | Proposed
Auto-Assist™ Software
Version 2.0 |
| Statistical
Functionality
Summary | Glucose Statistics:
Average blood glucose
concentration
Number of readings
Number of days
Target blood glucose range
Percent of readings above,
below, and within target range
Standard deviation of blood
glucose readings
Insulin Statistics:
Avg/Day
Avg/Day Total | Same |
| Hardware
Requirements | CD-ROM drive (not required if
application is loaded from
internet)
Mouse
Printer (if user wants to print)
Internet connectivity (for host or
e-mail Communication)
Class I fax-enabled modem
(required for fax capabilities
only)
Data Cable
USB port | Same |
| Data Transfer | Serial or Serial/USB adapter
Communication cables. | Same |
| Compatible
Blood Glucose
Meters | Precision Xtra™
Freestyle Freedom™
FreeStyle Lite
FreeStyle Freedom Lite | Same |
| Feature | Predicate CoPilot Diabetes
Data Management System | Proposed
Auto-Assist™ Software
Version 2.0 |
| Languages | English | Same |
Image /page/3/Picture/10 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a stylized letter "A" on the left, followed by the words "Abbott" in bold, and "Diabetes Care" in a smaller font size below it. The logo is simple and professional, and it is likely used to represent the company and its products.
4
.
·
·
Image /page/4/Picture/1 description: The image shows the logo for Abbott Diabetes Care. The logo consists of two parts: a stylized letter "a" on the left and the text "Abbott Diabetes Care" on the right. The word "Abbott" is in bold, while "Diabetes Care" is in a regular font.
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The differences between FreeStyle Auto-Assist Software Version 2.0 and the predicate are highlighted below:
| Feature | Predicate CoPilot Diabetes
Data Management System | Proposed
Auto-Assist™ Software
Version 2.0 |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CoPilot Health Management
System is intended for use as an
accessory to the Freestyle and
Precision Xtra blood glucose
monitoring systems and some
commercially available blood
glucose meters and insulin
pumps. The CoPilot Health
Management System is intended
for use in home and clinical
settings to upload data from
these devices to a patient's or
healthcare professional's
computer where the data may be
saved, displayed in a number of
formats, printed, or exported to
an authorized user.
The CoPilot System is intended
to aid people with diabetes and
healthcare professionals in the
review, analysis, and evaluation
of historical blood glucose test
results, insulin dosages, and
carbohydrate intake data to
support an effective diabetes
management program. | The FreeStyle Auto-Assist
Software Version 2.0 is
intended for use by people
with diabetes to
aid in the review, analysis and
evaluation of information such
as blood glucose test results,
blood ketone test results and
other data uploaded from a
meter, such as insulin doses
and exercise data, in
support of an effective
diabetes health management
program.
FreeStyle Auto-Assist
software is not intended for the
diagnosis of or screening for
diabetes mellitus. |
| Indications for
Use | People with diabetes
Healthcare Professionals | People with diabetes |
| Feature | Predicate CoPilot Diabetes
Data Management System | Proposed
Auto-Assist™ Software
Version 2.0 |
| Import Capability | Event Importing:
Tab delimited files
XML Files | No import capability |
| | Database Importing:
Precision Link (V.2.5 or higher)
FreeStyle Connect
CoZMonitor | |
| Compatible Blood
Glucose Meters | Precision® Xceed
Freestyle®
Freestyle Tracker®
Freestyle Navigator®
Continuous Glucose
Monitoring System | Freestyle Insulinx
Freestyle 5
K092638
Freestyle Flash
K092638 |
| Operating System | Microsoft Windows 98SE 2000
and XP | Microsoft Windows 7 (32 or
64 bit), Vista, or Windows XP
Mac OS X Snow Leopard or
Lion |
| Statistical
Functionality
Summary | Pump Statistics:
Avg/Day Meal Bolus
Avg/Day Correction Bolus
Avg/Day Total Bolus
Avg/Day Basal
Avg/Day Total Insulin | None |
| Hardware
Requirements | Co-Pilot for FreeStyle
Navigator:
Pentium 4 or above
512Mb
Kensington USB Bluetooth
Adapter and compatible
Widcomm driver (if
downloading data from
FreeStyle Navigator) | Not compatible with FreeStyle
Navigator |
| Languages | No Spanish translation | Spanish |
| Feature | Predicate CoPilot Diabetes
Data Management System | Proposed
Auto-Assist™ Software
Version 2.0 |
| Graphic Data
Displays | Glucose data readings are
displayed graphically along with
the user-defined target range.
Glucose data readings above
target are displayed as purple
and below target range as
yellow.
Triangle = Discrete data
Circle = Continuous data
Square = Manually entered
glucose
Above target = purple
Within target = green
Below target = yellow | Glucose data readings are
displayed graphically along
with the user-defined target
range
Glucose data readings above
target are displayed as green,
on target as blue, and below
target as gray.
Open Circle = Average blood
glucose
Closed Circle = Discrete blood
glucose data
Up-Arrow = blood glucose
value greater than 350mg/dl |
| Data Transfer | Co-Pilot System for FreeStyle
Navigator functionality
communicates with FreeStyle
Navigator via Kensington
Bluetooth adapter/driver. | Micro-USB/USB adapter |
| Storage Capacity | CoPilot storage capacity is
limited by the amount of
available hard disk storage space | None |
Image /page/5/Picture/3 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a stylized letter "a" on the left, followed by the word "Abbott" in bold, and the words "Diabetes Care" below it. The text is in a simple, sans-serif font.
6
.
Image /page/6/Picture/1 description: The image contains the logo for Abbott Diabetes Care. The logo consists of a stylized letter 'A' on the left, followed by the word 'Abbott' in bold, and 'Diabetes Care' written below it. The text is in a simple, sans-serif font.
.
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Summary of Testing:
The FreeStyle Auto-Assist Software Version 2.0 underwent verification and validation testing. A brief summary of the tests performed is described below.
These studies demonstrated that the FreeStyle Auto-Assist Software Version 2.0 performed according to the specifications and the intended use.
Software Verification and Validation
FreeStyle Auto-Assist Software Version 2.0 was validated pursuant to the moderate level of concern requirements. Design validation testing confirmed that the software performs according to the stated intended use. Software evaluation consisted of functional testing and code inspections which was performed on FreeStyle Auto-Assist Software Version 2.0's design verification. The software was developed in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical
Image /page/7/Picture/6 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a stylized letter "a" on the left, followed by the words "Abbott" and "Diabetes Care" stacked on top of each other on the right. The text is in a bold, sans-serif font.
8
Devices (May 11, 2005) and General Principles of Software Validation 1/11/2002: Final Guidance for Industry and FDA Staff, where applicable and appropriate,
A total of 35 participants of typical computer experience (used computer at least 4 times per week) and ages (age range 18 to 66 years old) that would be expected to use diabetes data management software were enrolled in the Human Factors study conducted for FreeStyle Auto-Assist Software Version 2.0 enrolled . All of the study participants had diabetes: 13 were Type 1 and 22 were Type 2. As part of the study, users installed the software on their test computer desktop and launched the software. Task 1 required the subjects to install the software. Task 2 required subjects to upload meter data and create and print reports, and Task 3 required subjects to save previously generated reports. Users were given either of two meters (16 were tested using Freestyle Freedom Lite meters and 18 with Precision Xtra meters), and were assessed on their ability to upload meter data, create and print reports, and save reports to their desktop. Meters were preloaded with data such as blood glucose or ketone results, based on the compatible meters, and users created reports and graphs using this stored data. Stored data was automatically uploaded from a compatible meter when it was connected to a computer running FreeStyle Auto-Assist Software Version 2.0.
Based on the study, 32 subjects were able to successfully create and view reports, and the data in these reports matched the stored data in 100% of cases.
Statement of Equivalence:
The FreeStyle Auto-Assist Software Version 2.0 is substantially equivalent to the predicate device with regards to its intended use and function. Both the subject and predicate devices are intended to allow people with diabetes to upload data from compatible meters into FreeStyle Auto-Assist Software Version 2.0, where users may review blood glucose and other data in a number of different graphical presentations.
Conclusion:
Based on the information provided in this premarket notification, the FreeStyle Auto-Assist Software Version 2.0 is substantially equivalent to the predicate device and is suitable for its intended use. The software is as safe, as effective and performs as well as the predicate device.
Image /page/8/Picture/7 description: The image shows the logo for Abbott Diabetes Care. The logo consists of a stylized letter "A" on the left, followed by the words "Abbott" and "Diabetes Care" stacked on top of each other on the right. The letter "A" is a geometric shape with a thick black outline, and the words are in a bold, sans-serif font.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/9/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the symbol. The text is in all caps and is in a sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2013
Abbott Diabetes Care Inc. C/O David G. Lambert 1360 South Loop Road ALAMEDA CA 94502
Re: K123089
Trade/Device Name: Freestyle Auto-Assist Software Version 2.0 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, JQP Dated: February 27, 2013 Received: February 28, 2013
Dear Mr. Lambert:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for
10
Page 2-Mr. Lambert
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Carol C. Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
11
Indications for Use Form
510(k) Number (if known): _K123089
Device Name: Freestyle Auto-Assist Software Version 2.0
Indications for Use:
The Freestyle Auto-Assist Software Version 2.0 is intended for use by people with diabetes to aid in the review, analysis and evaluation of information such as blood glucose results, blood ketone test results and other data uploaded from a compatible meter, such as insulin doses and exercise data from the Freestyle Insulinx meter, in support of an effective diabetes health management program.
Freestyle Auto-Assist software is not intended for the diagnosis of or screening for diabetes mellitus
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 Devices and Radiologic Health (OIR)
Katherine Serrano
Division Sign-Off Office of In Vitro Devices and Radiologic Health
510(k)_k123089
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