WellDoc BlueStar, WellDoc BlueStar Rx

K162532 · Welldoc, Inc. · MRZ · Jan 12, 2017 · General Hospital

Device Facts

• Record ID: K162532
• Device Name: WellDoc BlueStar, WellDoc BlueStar Rx
• Applicant: Welldoc, Inc.
• Product Code: MRZ · General Hospital
• Decision Date: Jan 12, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The WellDoc BlueStar® System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older - who have type 2 diabetes. The BlueStar System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. The BlueStar® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

Device Story

WellDoc BlueStar/BlueStar Rx is a software system for type 2 diabetes management; used by patients and HCPs in home or clinical settings. Inputs include manual entry of blood glucose, medication, carbohydrate, and activity data; also receives blood glucose data via Bluetooth from OneTouch Verio Flex meter. System acts as information repository, logbook, and educational resource; provides motivational/behavioral coaching based on real-time glucose trends. BlueStar Rx includes an insulin dose calculator for prescribed regimens. Output displayed on mobile app or web portal; assists patients in self-management and provides decision support for HCPs. Data can be transmitted to OneTouch Reveal Server. Benefits include improved medication adherence and diabetes self-management through real-time feedback and structured data tracking.

Clinical Evidence

Bench testing only. Software verification, validation, and human factors testing demonstrated the system functions as intended and can be used by laypersons without HCP oversight, while the insulin dose calculator remains under HCP oversight.

Technological Characteristics

Standalone software system for mobile phones and PCs. Features Bluetooth connectivity for glucose meter integration. Implemented as enterprise-based platform with patient mobile/web applications and HCP service portal. Software-based insulin dose calculator (Rx-only).

Indications for Use

Indicated for adult patients (aged 21+) with type 2 diabetes and their healthcare providers to aid in diabetes self-management, including blood glucose data capture, storage, transmission, analysis, and medication adherence support.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• WellDoc DiabetesManager® System and Diabetes Manager®-Rx System (K100066)

Reference Devices

• WellDoc BlueStar®/ DiabetesManager® System and Diabetes Manager®-Rx System (K162225)
• One Touch Verio Flex Blood Glucose Meter (K150214)

Submission Summary (Full Text)

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May 21, 2024

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WellDoc, Incorporated Danielle Dorfman Manager, Regulatory Affairs and Quality System 10221 Wincopin Circle Suite 150 Columbia, Maryland 21044

Re: K162532

Trade/Device Name: WellDoc® BlueStar®, WellDoc® BlueStar® Rx Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: MRZ, NDC

Dear Danielle Dorfman:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 12, 2017. Specifically, FDA is updating this SE letter as an administrative correction. A secondary product code, LNX, was inadvertently included.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Marianela Perez-Torres, OHT7: Office of In Vitro Diagnostics Devices, 301-796-1489, [e-mail].

Sincerely,

Marianela Perez-torres -S

Marianela Perez-Torres, Ph.D. Director DHT7: Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 12, 2017

WellDoc, Incorporated Danielle Dorfman Manager, Regulatory Affairs and Quality System 10221 Wincopin Circle, Suite 150 Columbia, Maryland 21044

Re: K162532

Trade/Device Name: WellDoc® BlueStar®, WellDoc® BlueStar®Rx Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ, LNX, NDC Dated: January 7. 2016 Received: January 9, 2017

Dear Danielle Dorfman:

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.

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K162532

Device Name WellDoc® BlueStar®

#### Indications for Use (Describe)

The WellDoc BlueStar® System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older - who have type 2 diabetes. The BlueStar System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.

The BlueStar® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

Type of Use (Select one or both, as applicable)| Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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# Indications for Use

510(k) Number (if known) K162532

Device Name WellDoc® BlueStar® Rx

### Indications for Use (Describe)

The WellDoc BlueStar® Rx System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older - who have type 2 diabetes. The BlueStar Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar Rx System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value.

The BlueStar® Rx System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

Type of Use (*Select one or both, as applicable*)

| <span></span> | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------|------------------------------------------------------------|
| <span></span> | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/5/Picture/0 description: The image contains the WellDoc logo. The logo features a stylized graphic of two hands intertwined in a circular shape, colored in shades of blue and teal. To the right of the graphic is the word "WellDoc" in a bold, blue font. A small registration mark is present next to the word.

# 510(k) Summary

# General Information

Date of Summary Preparation: December 19, 2016

| Name of Manufacturer: | WellDoc, Inc. |
|----------------------------|-------------------------------------------------------------|
| Address: | 10221 Wincopin Circle Suite 150<br>Columbia, MD 21044 |
| Contact Person: | Kevin McRaith<br>Chief Executive Officer |
| Phone: | [phone] |
| Fax: | [phone] |
| Trade or Proprietary Name: | WellDoc® BlueStar®."Y gmF qeÌ BlueStar® Rx |
| Common or Usual Name: | Medical computers and software<br>Infusion pump accessories |
| Product Codes: | MRZ, LNX, NDC |
| Classification Name: | Infusion Pump<br>21 CFR 880.5725 (Infusion Pump) |
| Regulatory Class: | II |
| Classification Panel: | General Hospital |

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Image /page/6/Picture/0 description: The image contains the logo for WellDoc. The logo consists of a blue and light blue graphic on the left, resembling intertwined hands or a circular shape. To the right of the graphic is the text "WellDoc" in a blue, sans-serif font. A small registration mark is present to the upper right of the word "WellDoc".

| Predicate Device: | K100066 (WellDoc DiabetesManager® System and Diabetes<br>Manager®-Rx System) |
|-------------------|-----------------------------------------------------------------------------------------|
| Reference Device: | K162225 (WellDoc BlueStar®/ DiabetesManager® System and<br>Diabetes Manager®-Rx System) |

## Device Description

WellDoc® BlueStar® is a stand-alone software system intended to be used by healthcare providers (HCPs) and their adult patients – aged 21 years and older - who have Type 2 Diabetes. The system is intended to assist Type 2 Diabetes patients to self-manage their disease, as cleared under K100066. Patients receive guidance on diabetes self-management and are encouraged to reach out to their healthcare team when needed. There are two versions of BlueStar® -BlueStar® and BlueStar® Rx - which differ in the availability of the insulin dose calculator, which is restricted to a prescription from a HCP.

BlueStar® and BlueStar® Rx are implemented through an enterprise such as a health plan or large physician group in tandem with a patient's healthcare team and are comprised of the following applications:

- Enterprise Director Portal ●
- . HCP Service
- . Patient Mobile Application
- . Patient Web Portal

The Enterprise Director application is used for administrative purposes (unchanged since cleared under K100066). The HCP Service houses the Medication Reconciliation feature, which allows

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Image /page/7/Picture/0 description: The image shows the WellDoc logo. The logo features a stylized graphic of two hands intertwined in a circular shape, with a gradient of blue and teal colors. To the right of the graphic is the word "WellDoc" in a bold, blue font. The logo is clean and professional, suggesting a focus on health and well-being.

for the process of identifying the most accurate list of all medications that the patient is taking, including name, dosage and frequency, by comparing the medical record to an external list of medications obtained from a patient, hospital, or other provider (cleared under K141273).

The Patient Web Portal and the Patient Mobile application have a similar feature set (unchanged since cleared under K100066). Data (including blood glucose values, medications, carbohydrates, and activity) entered into these applications is stored in the database and can be retrieved for display in either applications require the initial web- or mobilebased registration before the patient can access them. On the patient applications (Mobile and Web), BlueStar® and BlueStar® Rx function as an (1) information repository (logbook and Personal Health Record) and (2) diabetes education resource (learning library and health tips) and provide (3) motivational, behavioral, and educational coaching based on real-time blood glucose values and trends, (4) a secure communication system (Message Center), (5) medication information (dose and schedule), and (6) workflow and decision support for healthcare providers.

In BlueStar® Rx, the patient web portal and mobile application also provide an insulin dosing calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. The insulin dose calculator is restricted to prescription-use only.

Furthermore, as cleared under K16225 (reference device), BlueStar® and BlueStar® Rx have the ability to connect to the One Touch Verio Flex Blood Glucose Meter (K150214) via Bluetooth. This will allow users to send data from their meter to the BlueStar® Rx app, which will provide coaching messages (motivational, behavioral, and educational) based on the real-time blood glucose values and trends. The BlueStar Server will also have the ability

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Image /page/8/Picture/0 description: The image shows the WellDoc logo. The logo features a stylized graphic of two hands intertwined in a circular shape, with a gradient of blue and teal colors. To the right of the graphic is the word "WellDoc" in a bold, blue font. The logo is clean and professional, suggesting a focus on health and well-being.

to transmit data to the OneTouch Reveal Server. These modifications do not change the fundamental scientific technology of the device.

## Indications for Use

OTC: The WellDoc BlueStar® System is indicated for use by healthcare providers (HCPs) and their adult patients – aged 21 years and older - who have type 2 diabetes. The BlueStar System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.

The BlueStar® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

Rx: The WellDoc BlueStar® Rx System is indicated for use by healthcare providers (HCPs) and their adult patients – aged 21 years and older - who have type 2 diabetes. The BlueStar Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar Rx System provides coaching messages (motivational, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software

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Image /page/9/Picture/0 description: The image contains the logo for WellDoc. The logo features a blue and teal intertwined circular design on the left. To the right of the design is the name "WellDoc" in blue font with a registered trademark symbol.

also allows for entry of other diabetes-related healthcare information and provides educational information. BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value.

The BlueStar® Rx System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

### Summary of Technological Characteristics (compared to the predicate)

Intended use, design, materials, and performance are substantially equivalent to the predicate device referenced. The differences between the subject and predicate devices are: (1) the ability to connect to the OneTouch Verio Flex Blood Glucose Meter via Bluetooth (to transmit BG values taken by the meter) and the ability to transmit data from the BlueStar Server to the OneTouch Reveal Server (as cleared under K162225); (2) change in indications for use to specify the insulin dose calculator as prescription-only (in BlueStar® Rx); and (3) change in indications for use to allow the coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends to be accessed over-the-counter (in both BlueStar® and BlueStar® Rx).

The modifications herein do not change the fundamental scientific technology of the BlueStar application and do not change the subject device's substantial equivalence to the predicate device.

Please refer to the table below for a comparison of the subject and predicate devices. Note that while both the predicate and subject device contain an insulin dose calculator with substantially

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Image /page/10/Picture/0 description: The image shows the WellDoc logo. The logo features a blue and teal circular design on the left, resembling intertwined hands. To the right of the design is the word "WellDoc" in a blue, sans-serif font. The logo appears to be for a healthcare or wellness-related company.

equivalent functionality, the predicate device was not identified with the NDC product code at

the time of clearance.

| Feature | Subject Device | Predicate Device, K100066 | Reference Device, K162225 |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | OTC: The WellDoc<br>BlueStar® System is indicated<br>for use by healthcare providers<br>(HCPs) and their adult patients<br>- aged 21 years and older -<br>who have type 2 diabetes. The<br>BlueStar System is intended to<br>provide secure capture,<br>storage, and transmission of<br>blood glucose data as well as<br>information to aid in diabetes<br>self-management. The<br>BlueStar® System analyzes<br>and reports blood glucose test<br>results and supports<br>medication adherence. In<br>addition, the BlueStar System<br>provides coaching messages<br>(motivational, behavioral, and<br>educational) based on real-<br>time blood glucose values and<br>trends. It includes software<br>intended for use on mobile<br>phones or personal computers<br>in the home or in professional<br>healthcare settings. The<br>software also allows for entry<br>of other diabetes-related<br>healthcare information and<br>provides educational<br>information.<br>The BlueStar® System is not<br>intended to replace the care<br>provided by a licensed<br>healthcare professional,<br>including prescriptions,<br>diagnosis, or treatment.<br><br>Rx: The WellDoc BlueStar®<br>Rx System is indicated for use<br>by healthcare providers<br>(HCPs) and their adult patients<br>- aged 21 years and older -<br>who have type 2 diabetes. The<br>BlueStar Rx System is<br>intended to provide secure<br>capture, storage, and<br>transmission of blood glucose | DiabetesManager (OTC Use):<br>The WellDoc DiabetesManager<br>® System is indicated for use by<br>healthcare providers (HCPs) and<br>their adult patients - aged 21<br>years and older - who have type<br>2 diabetes. The DiabetesManager<br>System is intended to provide<br>secure capture, storage, and<br>transmission of blood glucose<br>data as well as information to aid<br>in diabetes self-management.<br>The DiabetesManager System<br>analyzes and reports blood<br>glucose test results and supports<br>medication adherence. It<br>includes software intended for<br>use on mobile phones or<br>personal computers in the home<br>or in professional healthcare<br>settings. The software also<br>allows for entry of other<br>diabetes-related healthcare<br>information and provides<br>educational information.<br><br>The DiabetesManager System is<br>not intended to replace the care<br>provided by a licensed healthcare<br>professional, including<br>prescriptions, diagnosis, or<br>treatment.<br><br>DiabetesManager-Rx<br>(Prescription Use):<br>The WellDoc DiabetesManager -<br>Rx System is indicated for use<br>by healthcare providers (HCPs)<br>and their adult patients - aged 21<br>years and older - who have type<br>2 diabetes. The<br>DiabetesManager-Rx System is<br>intended to provide secure<br>capture, storage, and<br>transmission of blood glucose<br>data as well as information to aid<br>in diabetes self-management.<br>The DiabetesManager -Rx<br>System analyzes and reports | DiabetesManager® (OTC<br>Use): The WellDoc<br>DiabetesManager® System is<br>indicated for use by<br>healthcare providers (HCPs)<br>and their adult patients - aged<br>21 years and older -who have<br>type 2 diabetes. The<br>Diabetes Manager® System is<br>intended to provide secure<br>capture, storage, and<br>transmission of blood<br>glucose data as well as<br>information to aid in diabetes<br>self-management. The<br>Diabetes Manager® System<br>analyzes and reports blood<br>glucose test results and<br>supports medication<br>adherence. It includes<br>software intended for use on<br>mobile phones or personal<br>computers in the home or in<br>professional healthcare<br>settings. The software also<br>allows for entry of other<br>diabetes-related healthcare<br>information and provides<br>educational information.<br><br>The Diabetes Manager®<br>System is not intended to<br>replace the care provided by<br>a licensed healthcare<br>professional, including<br>prescriptions, diagnosis, or<br>treatment.<br><br>DiabetesManager®-Rx<br>(Prescription Use): The<br>WellDoc<br>DiabetesManager®-Rx<br>System is indicated for use<br>by healthcare providers<br>(HCPs) and their adult<br>patients - aged 21 years and<br>older - who have type 2<br>diabetes. The<br>DiabetesManager®-Rx<br>System is intended to provide<br>secure capture, storage, and |
| | | | |
| | aid in diabetes self-<br>management. The BlueStar®<br>Rx System analyzes and<br>reports blood glucose test<br>results and supports<br>medication adherence. In<br>addition, the BlueStar Rx<br>System provides coaching<br>messages (motivational,<br>behavioral, and educational)<br>based on real-time blood<br>glucose values and trends. It<br>includes software intended for<br>use on mobile phones or<br>personal computers in the<br>home or in professional<br>healthcare settings. The<br>software also allows for entry<br>of other diabetes-related<br>healthcare information and<br>provides educational<br>information. BlueStar® Rx<br>includes an insulin dose<br>calculator to allow patients to<br>use their prescribed regimen to<br>calculate a dose of insulin for<br>a given amount of<br>carbohydrates and/or blood<br>glucose value.<br>The BlueStar® Rx System is<br>not intended to replace the<br>care provided by a licensed<br>healthcare professional,<br>including prescriptions,<br>diagnosis, or treatment. | blood glucose test results and<br>supports medication adherence.<br>In addition, the DiabetesManager<br>-Rx System provides coaching<br>messages (motivational,<br>behavioral, and educational)<br>based on real-time blood glucose<br>values and trends. It includes<br>software intended for use on<br>mobile phones or personal<br>computers in the home or in<br>professional healthcare settings.<br>The software also allows for<br>entry of other diabetes-related<br>healthcare information and<br>provides educational<br>information.<br>The DiabetesManager-Rx<br>System is not intended to replace<br>the care provided by a licensed<br>healthcare professional,<br>including prescriptions,<br>diagnosis, or treatment. | transmission of blood<br>glucose data as well as<br>information to aid in diabetes<br>self-management. The<br>DiabetesManager®-Rx<br>System analyzes and reports<br>blood glucose test results and<br>supports medication<br>adherence. In addition, the<br>DiabetesManager®-Rx<br>System provides coaching<br>messages (motivational,<br>behavioral, and educational)<br>based on real-time blood<br>glucose values and trends. It<br>includes software intended<br>for use on mobile phones or<br>personal computers in the<br>home or in professional<br>healthcare settings. The<br>software also allows for entry<br>of other diabetes-related<br>healthcare information and<br>provides educational<br>information.<br>The DiabetesManager®-Rx<br>System is not intended to<br>replace the care provided by<br>a licensed healthcare<br>professional, including<br>prescriptions, diagnosis, or<br>treatment. |
| Type of Use | OTC, Rx | OTC, Rx | OTC. Rx |
| Product Code | LNX, MRZ, NDC | LNX, MRZ | LNX, MRZ, NDC |
| Classification | 21 CFR 880.5725 | 21 CFR 880.5725 | 21 CFR 880.5725 |
| Class | | | |
| Data Provided to<br>Support<br>Substantial<br>Equivalence<br>(Performance<br>Data) | Software Verification,<br>Software Validation, Human<br>Factors Testing | Software Verification, Software<br>Validation, Human Factors<br>Testing | Software Verification,<br>Software Validation, Human<br>Factors Testing |
| Manual Data<br>Entry | Yes | Yes | Yes |
| Logbook (BG<br>values, Carbs,<br>Activity) | Yes | Yes | Yes |
| Real-time<br>Feedback on BG<br>values (coaching<br>messages) | Yes | Yes | Yes |
| Pattern Detection.<br>Graphs, Charts | Yes | Yes…