(186 days)
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.
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 provided text describes the Abbott Diabetes Care Inc. FreeStyle Auto-Assist Software Version 2.0 (K123089) and its accompanying verification and validation testing. The acceptance criteria are implicitly defined by the successful performance of the software in these tests in accordance with FDA guidance.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the successful completion of the studies and the statement that the software performed "according to the specifications and the intended use." The primary reported performance metric is related to the accuracy of report generation and data representation.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software installation by typical users | All participants were able to install the software. |
| Successful upload of meter data by typical users | All participants were able to upload meter data. |
| Successful creation and printing of reports by typical users | 32 out of 35 subjects (approx. 91.4%) were able to successfully create and view reports. |
| Successful saving of reports by typical users | All participants were able to save reports to their desktop (implied from successful task completion). |
| Data in generated reports matches stored data | The data in these reports matched the stored data in 100% of cases. |
| Performance according to specifications and intended use | Studies "demonstrated that the FreeStyle Auto-Assist Software Version 2.0 performed according to the specifications and the intended use." (General statement). |
| Conformance to FDA Guidance for Software in Medical Devices | Software developed in accordance with FDA 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. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 35 participants.
- 16 were tested using FreeStyle Freedom Lite meters.
- 18 were tested using Precision Xtra meters.
- Data Provenance: Not explicitly stated regarding country of origin, but the study was a Human Factors study meaning it involved human participants interacting with the software. It involved preloaded data in the meters, which users then uploaded. Given the context of an FDA submission for a US market, it's reasonable to infer the data provenance is likely related to the US, but this is not explicitly stated. The study appears to be prospective in terms of user interaction and performance assessment, as users were actively performing tasks with the software. The meter data itself was "preloaded" implying simulated or previously collected data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The concept of "ground truth" for the test set in this context is primarily related to the accuracy of the software's functionality (e.g., does it correctly upload data, does the generated report match the preloaded data). The document states, "The data in these reports matched the stored data in 100% of cases." This suggests that the ground truth for the data accuracy was the preloaded data itself, and the software's output was compared against that.
There is no mention of external experts/clinicians establishing a "ground truth" for interpretations or clinical decisions, as this software is for data review and analysis, not diagnosis. The "experts" in validating the software's function would be the software testers/engineers responsible for verifying the output against expected results, but their number and qualifications are not provided in this summary.
4. Adjudication Method for the Test Set
Not applicable. This was a Human Factors study evaluating user interaction and software functionality, not a clinical assessment requiring adjudication of diagnostic findings. The assessment was based on participants' ability to complete tasks and the software's accurate representation of preloaded data.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. This document does not describe an MRMC comparative effectiveness study. The study focused on the usability and functional performance of the FreeStyle Auto-Assist Software Version 2.0 by individual users, not a comparison of human readers with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
The primary study described is a Human Factors study, which does involve human-in-the-loop performance. However, the statement "Software evaluation consisted of functional testing and code inspections which was performed on FreeStyle Auto-Assist Software Version 2.0's design verification" implies that standalone algorithm testing (without human-in-the-loop) was performed as part of the overall software verification and validation process. The specific details of this standalone testing are not provided in this summary, but it would be a standard part of software development and validation.
7. The Type of Ground Truth Used
The ground truth used for the data accuracy assessment was the "stored data" that was preloaded into the meters. The "ground truth" for successful task completion was the pre-defined steps required for installation, data upload, report generation/printing, and saving.
8. The Sample Size for the Training Set
Not applicable. This document describes the validation of a software application that processes and presents data from blood glucose meters. It is not an AI/ML algorithm that requires a "training set" in the traditional sense. The software's logic is rule-based and deterministic for data handling and report generation, rather than learned from a large dataset.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of software.
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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 processingmodule, for clinical use | |
| Classification Name | i) Glucose test system. (21 CFR862.1345, Product Code NBW) |
| ii) Calculator/data processing module,for clinical use. (21 CFR 862.2100, ProductCode JQP) | |
| Predicate Device: | CoPilot™ Health Management SystemCleared 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 daterange. It also includes notes that inform thepatient and their healthcare professional aboutimportant trends in blood glucose data byputting the data into words |
| Modal Day | Shows the daily pattern of glucose levels overthe 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 DiabetesData Management System | ProposedAuto-Assist™ SoftwareVersion 2.0 |
|---|---|---|
| Editing of PatientData | Does not allow user to edit dataretrieved from a meter | Same |
| Feature | Predicate CoPilot DiabetesData Management System | ProposedAuto-Assist™ SoftwareVersion 2.0 |
| StatisticalFunctionalitySummary | Glucose Statistics:Average blood glucoseconcentrationNumber of readingsNumber of daysTarget blood glucose rangePercent of readings above,below, and within target rangeStandard deviation of bloodglucose readingsInsulin Statistics:Avg/DayAvg/Day Total | Same |
| HardwareRequirements | CD-ROM drive (not required ifapplication is loaded frominternet)MousePrinter (if user wants to print)Internet connectivity (for host ore-mail Communication)Class I fax-enabled modem(required for fax capabilitiesonly)Data CableUSB port | Same |
| Data Transfer | Serial or Serial/USB adapterCommunication cables. | Same |
| CompatibleBlood GlucoseMeters | Precision Xtra™Freestyle Freedom™FreeStyle LiteFreeStyle Freedom Lite | Same |
| Feature | Predicate CoPilot DiabetesData Management System | ProposedAuto-Assist™ SoftwareVersion 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.
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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 DiabetesData Management System | ProposedAuto-Assist™ SoftwareVersion 2.0 |
|---|---|---|
| Intended Use | The CoPilot Health ManagementSystem is intended for use as anaccessory to the Freestyle andPrecision Xtra blood glucosemonitoring systems and somecommercially available bloodglucose meters and insulinpumps. The CoPilot HealthManagement System is intendedfor use in home and clinicalsettings to upload data fromthese devices to a patient's orhealthcare professional'scomputer where the data may besaved, displayed in a number offormats, printed, or exported toan authorized user.The CoPilot System is intendedto aid people with diabetes andhealthcare professionals in thereview, analysis, and evaluationof historical blood glucose testresults, insulin dosages, andcarbohydrate intake data tosupport an effective diabetesmanagement program. | The FreeStyle Auto-AssistSoftware Version 2.0 isintended for use by peoplewith diabetes toaid in the review, analysis andevaluation of information suchas blood glucose test results,blood ketone test results andother data uploaded from ameter, such as insulin dosesand exercise data, insupport of an effectivediabetes health managementprogram.FreeStyle Auto-Assistsoftware is not intended for thediagnosis of or screening fordiabetes mellitus. |
| Indications forUse | People with diabetesHealthcare Professionals | People with diabetes |
| Feature | Predicate CoPilot DiabetesData Management System | ProposedAuto-Assist™ SoftwareVersion 2.0 |
| Import Capability | Event Importing:Tab delimited filesXML Files | No import capability |
| Database Importing:Precision Link (V.2.5 or higher)FreeStyle ConnectCoZMonitor | ||
| Compatible BloodGlucose Meters | Precision® XceedFreestyle®Freestyle Tracker®Freestyle Navigator®Continuous GlucoseMonitoring System | Freestyle InsulinxFreestyle 5K092638Freestyle FlashK092638 |
| Operating System | Microsoft Windows 98SE 2000and XP | Microsoft Windows 7 (32 or64 bit), Vista, or Windows XPMac OS X Snow Leopard orLion |
| StatisticalFunctionalitySummary | Pump Statistics:Avg/Day Meal BolusAvg/Day Correction BolusAvg/Day Total BolusAvg/Day BasalAvg/Day Total Insulin | None |
| HardwareRequirements | Co-Pilot for FreeStyleNavigator:Pentium 4 or above512MbKensington USB BluetoothAdapter and compatibleWidcomm driver (ifdownloading data fromFreeStyle Navigator) | Not compatible with FreeStyleNavigator |
| Languages | No Spanish translation | Spanish |
| Feature | Predicate CoPilot DiabetesData Management System | ProposedAuto-Assist™ SoftwareVersion 2.0 |
| Graphic DataDisplays | Glucose data readings aredisplayed graphically along withthe user-defined target range.Glucose data readings abovetarget are displayed as purpleand below target range asyellow.Triangle = Discrete dataCircle = Continuous dataSquare = Manually enteredglucoseAbove target = purpleWithin target = greenBelow target = yellow | Glucose data readings aredisplayed graphically alongwith the user-defined targetrangeGlucose data readings abovetarget are displayed as green,on target as blue, and belowtarget as gray.Open Circle = Average bloodglucoseClosed Circle = Discrete bloodglucose dataUp-Arrow = blood glucosevalue greater than 350mg/dl |
| Data Transfer | Co-Pilot System for FreeStyleNavigator functionalitycommunicates with FreeStyleNavigator via KensingtonBluetooth adapter/driver. | Micro-USB/USB adapter |
| Storage Capacity | CoPilot storage capacity islimited by the amount ofavailable 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.
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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.
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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
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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
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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
Page 1 of 1
§ 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.