(87 days)
No
The summary describes a data management system for blood glucose readings, focusing on data transfer, display, and sharing. There is no mention of AI or ML algorithms for analysis, prediction, or interpretation of the data beyond basic review and evaluation. The performance studies focus on software verification and validation, not the performance of an AI/ML model.
No
The device is described as data management software that aids in the review, analysis, and evaluation of blood glucose readings. It explicitly states, "The Glooko device system for Glooko Application is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice." This indicates it does not provide direct therapy.
No
This device is described as "data management software intended for use in home and professional settings to aid individuals with diabetes and their health care professionals in review, analysis and evaluation of blood glucose readings." It explicitly states that it is "not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice," indicating it doesn't diagnose.
No
The device description explicitly lists "The Glooko MeterSync Cable for Android" as a component, indicating it includes hardware in addition to the software application.
Based on the provided text, the Glooko device system for Glooko Application is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for data management software to aid individuals and healthcare professionals in the review, analysis, and evaluation of blood glucose readings. It explicitly states it is not intended to provide treatment decisions or be used as a substitute for professional healthcare advice.
- Device Description: The description reinforces that the system is used for the download, review, analysis, evaluation, and communication of blood glucose readings. It does not perform any tests on biological samples.
- Functionality: The system connects to compatible FDA cleared meters and allows users to transfer their blood glucose meter results. The blood glucose meters themselves are the IVDs that perform the diagnostic test on the blood sample. The Glooko system is a tool for managing the data generated by those IVDs.
IVD devices are specifically designed to perform tests on biological samples (like blood, urine, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Glooko system does not perform such tests; it processes and displays data from devices that do.
N/A
Intended Use / Indications for Use
The Glooko device system for Glooko Application is data management software intended for use in home and professional settings to aid individuals with diabetes and their healthcare professionals in review, analysis and evaluation of blood glucose readings to support an effective diabetes management program. The Glooko device system for Glooko Application connects to compatible FDA cleared meters and allows users to transfer their blood glucose meter results to their mobile devices running on Android operating system.
The Glooko device system for Glooko Application is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
Product codes
NBW, JQP
Device Description
The Glooko device system for Glooko Application is used to aid individuals with diabetes in the download, review, analysis, evaluation, and communication of their blood glucose readings. The system allows users to download readings from compatible, FDA-cleared, commercial blood glucose meters to their Android Operating System mobile devices, and then share this information with healthcare professionals. It is intended for use both in home and professional settings to support an effective diabetes management program. The data may be displayed on supported devices to provide an online view of all collected data and notes from the Glooko Android Application. The system does not provide treatment decisions and cannot be used as a substitute for professional healthcare advice.
The Glooko device system for Glooko Application consists of the following components:
-
- The Glooko MeterSync Cable for Android
-
- The Glooko Application
The Glooko MeterSync Cable downloads data from compatible, FDA-cleared, commercial blood glucose meters into an Android operating mobile device by connecting the two components. One end of the Glooko MeterSync Cable plugs directly into the 3.5 mm slot of the Android device. The 3.5mm end of the Glooko MeterSync Cable plugs directly into most compatible meters to allow for the transfer of data. Some meters require an additional 3.5mm to 2.5mm adapter to allow for this connectivity, while other meters transfer data through infrared, and thus require the use of the IR Adapter, which is integrated into the Glooko MeterSync Cable. The IR Adapter is designed to transmit data via infrared from a variety of compatible, FDA-cleared, commercial blood glucose meters that require infrared for data transfer.
The Glooko MeterSync Cable is designed to attach to a variety of compatible, FDAcleared, commercial blood glucose meters. The users simply connect the supported meters to their Android mobile device and transfer the blood glucose meter data into the Glooko Android Application.
The Glooko Application is one component of the Glooko data monitoring system used to aid individuals with diabetes in the review, analysis, evaluation, and communication of their blood glucose readings.
The Glooko Application collects and stores historical blood glucose data that has been downloaded from blood glucose meters. The Glooko Application also lets the user sync and view data from any supported compatible device when using the appropriate login information.
The Glooko Application keeps an organized log of the users blood glucose readings and allows for the addition of user-generated notes and meal tags. The Glooko Application also shows graphs, provides statistics, and allows for the sharing and viewing of blood glucose data across multiple supported devices running on Android.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home and professional 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)
The Glooko Application underwent verification and validation testing. These studies demonstrated that the Glooko Device System for Glooko Application performed according to the specifications and the intended use.
Software Verification and Validation:
The Glooko Device system (Glooko Application, and Cable) was validated pursuant to the moderate level of concern requirements. Design validation testing confirmed that the Glooko device performs according to the stated intended use. Device evaluation consisted of functional testing performed pursuant to Glooko's design verification protocol, which referenced FDA's guidance document for medical devices containing software. Such testing included Data Integrity Verification, Software Design/features Verification, and error handling testing. All test results fell within the pre-determined specification parameters.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K090495, K042080, K080641, K040670, K091820, K121087
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Ki32272
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Glooko Device system for Glooko Application Special 510(k) Submission K132272 Page 1 of 7
510(k) Summary (21 CFR § 807.92(c))
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter: | Glooko, Inc. 170A University Avenue Palo Alto, CA 94301 |
|---|---|
| Contact: | Shilpa Mydur Director of Regulatory Affairs Phone: 650.720.5310 Email: shilpa@glooko.com |
| Date Summary Prepared: | 16 October 2013 |
| Device Trade Name: | Glooko Device System for Glooko Application |
| Common Name: | Blood Glucose Meter and Data Management System |
| Classification Name: | Glucose test system (21 CFR §862.1345) Calculator/data processing module for clinical use (21 CFR §862.2100) |
| Product Code: | NBW and JQP |
| Equivalent Device: | Glooko Device System for Glooko Logbook+ Application (K130886) |
OCT 17 2013#### Device Description:
Overview
The Glooko device system for Glooko Application is used to aid individuals with diabetes in the download, review, analysis, evaluation, and communication of their blood glucose readings. The system allows users to download readings from compatible, FDA-cleared, commercial blood glucose meters to their Android Operating System mobile devices, and then share this information with healthcare professionals. It is intended for use both in home and professional settings to support an effective diabetes management program. The data may be displayed on supported devices to provide an online view of all collected data and notes from the Glooko Android Application. The system does not provide treatment decisions and cannot be used as a substitute for professional healthcare advice.
1
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Glooko Device system for Glooko Application Special 510(k) Submission K132272 Page 2 of 7
The Glooko device system for Glooko Application consists of the following components
-
- The Glooko MeterSync Cable for Android
-
- The Glooko Application
Glooko MeterSync Cable
The Glooko MeterSync Cable downloads data from compatible, FDA-cleared, commercial blood glucose meters into an Android operating mobile device by connecting the two components. One end of the Glooko MeterSync Cable plugs directly into the 3.5 mm slot of the Android device. The 3.5mm end of the Glooko MeterSync Cable plugs directly into most compatible meters to allow for the transfer of data. Some meters require an additional 3.5mm to 2.5mm adapter to allow for this connectivity, while other meters transfer data through infrared, and thus require the use of the IR Adapter, which is integrated into the Glooko MeterSync Cable. The IR Adapter is designed to transmit data via infrared from a variety of compatible, FDA-cleared, commercial blood glucose meters that require infrared for data transfer.
The Glooko MeterSync Cable is designed to attach to a variety of compatible, FDAcleared, commercial blood glucose meters. The users simply connect the supported meters to their Android mobile device and transfer the blood glucose meter data into the Glooko Android Application.
The Glooko Application:
The Glooko Application is one component of the Glooko data monitoring system used to aid individuals with diabetes in the review, analysis, evaluation, and communication of their blood glucose readings.
The Glooko Application collects and stores historical blood glucose data that has been downloaded from blood glucose meters. The Glooko Application also lets the user sync and view data from any supported compatible device when using the appropriate login information.
The Glooko Application keeps an organized log of the users blood glucose readings and allows for the addition of user-generated notes and meal tags. The Glooko Application also shows graphs, provides statistics, and allows for the sharing and viewing of blood glucose data across multiple supported devices running on Android.
The Glooko Application is compatible with the following FDA-cleared blood glucose meters:
- . Abbott: FreeStyle Freedom Lite®, FreeStyle Lite®
- Bayer: Bayer's BREEZE®2, Bayer's CONTOUR®, Bayer's CONTOUR® NEXT EZ .
- LifeScan: OneTouch® Ultra®2, OneTouch® UltraLink®, OneTouch® UltraMini® ●
- Nipro: Nipro TRUEbalance™ (K090495), Nipro TRUEread ™ (K042080), Nipro . TRUEresult (K080641), Nipro TRUEtrack™(K040670)
- Roche: ACCU-CHEK® Aviva, ACCU-CHEK® Compact Plus, ACCU-CHEK® Nano .
- USB Meters: Bayer's Contour USB (K091820), Bayer's Contour Next USB . (K121087)
COMPANY CONFIDENTIAL DO NOT COPY
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Glooko Device system for Glooko Application Special 510(k) Submission K132272 Page 3 of 7
The Glooko Application can be operated on the following mobile devices, each supporting Android OS 2.3.3 and higher:
- HTC Desire HD (A9191), HTC Evo (PC36100), HTC Incredible S S710e ●
- LG Nexus 4, LG Optimus 2X (LG-P990) .
- . Motorola DROID X
- Samsung Ace (GT-S5830T), Samsung Galaxy Nexus, Samsung Galaxy Note o (GT-N7000), Samsung Galaxy Note II (GT-N7100), Samsung Galaxy S+ (GT-19001), Samsung Galaxy S II (GT-19100), Samsung Galaxy S II (SGH-1757M), Samsung Galaxy S III (GT-19300), Samsung Galaxy SIIII (GT-I9500)
The USB OTG Cable can be operated on the following Android devices, each supporting OS 3.1 and higher:
- Samsung Galaxy Nexus .
- . Samsung Note II (GT-N7100)
- . Samsung Galaxy SII (SGH-1757M)
- Samsung Galaxy SIII (GT-19300) .
- Samsung Galaxy SIIII (GT-19500) .
The Glooko Application is compatible with the following web browsers:
- Internet Explorer- v8.0 and above .
- Firefox- v3.0 and above .
- Chrome- v14.0 and above .
- . Safari-v4.0 and above
- iOS (Safari)- v3.0 and above .
Software Requirements:
The Glooko Application performs the following functions:
- Sync with compatible meters ●
- Allow users to annotate readings with notes ●
- Provide multiple view options for the data ●
- .Share the collected data .
- Transmit and view readings, graphs, statistics and notes across supported . multiple devices and web browsers when using consistent authentication credentials (username and password)
- Ability to connect to USB supported blood glucose meters using an off the shelf . micro USB cable
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Glooko Device system for Glooko Application Special 510(k) Submission K132272 Page 4 of 7
Technological Characteristics:
.
The table below provides the comparison of technological characteristics between the subject and predicate device ﺎ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
| Product | Glooko Device System for Glooko
Logbook+ Application
K130886
(Predicate Device) | Glooko Device System for
Glooko Application
K132272
(Subject Device) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Indications for Use | The Glooko device system for
Glooko Application is data
management software intended for
use in home and professional
settings to aid individuals with
diabetes and their health care
professionals in review, analysis
and evaluation of blood glucose
readings to support an effective
diabetes management program. The
Glooko device system for Glooko
Application connects to compatible
FDA cleared meters and allows
users to transfer their blood glucose
meter results to their mobile
devices.
The Glooko device system for
Glooko Application is not intended
to provide treatment decisions or to
be used as a substitute for
professional healthcare advice. | Same |
| Software | Glooko Logbook+ Application
(iOS platform) | Glooko Application (Android
operating system platform) |
| Hardware | MeterSync Cable
IR Adapter | MeterSync Cable with integrated IR
Adapter |
Table 1: Summary of Technological Characteristics
4
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Glooko Device system for Glooko Application
Special 510(k) Submission
| Product | Glooko Device System for Glooko
Logbook+ Application
K130886
(Predicate Device) | Glooko Device System for
Glooko Application
K132272
(Subject Device) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Blood glucose meter
compatibility | Abbott: FreeStyle Freedom Lite®,
FreeStyle Lite®
Bayer: Bayer's BREEZE®2, Bayer's
CONTOUR®, Bayer's CONTOUR®
NEXT EZ.
LifeScan: OneTouch® Ultra®2,
OneTouch® UltraLink®,
OneTouch® UltraMini®
Roche: ACCU-CHEK® Aviva,
ACCU-CHEK® Compact Plus,
ACCU-CHEK® Nano | Abbott: FreeStyle Freedom Lite®,
FreeStyle Lite®
Bayer: Bayer's BREEZE® 2,
Bayer's CONTOUR®, Bayer's
CONTOUR® NEXT EZ, Bayer's
LifeScan:OneTouch® Ultra®2,
OneTouch® UltraLink®, and
OneTouch® UltraMini®
Roche: ACCU-CHEK® Aviva,
ACCU-CHEK® Compact Plus,
ACCU-CHEK® Nano |
| Meters not supported
by the predicate device
but supported by
current device | | Nipro TRUEbalance™ (K090495),
Nipro TRUEread ™ (K042080),
Nipro TRUEresult (K080641),
Nipro TRUEtrack™(K040670)
Bayer's Contour USB (K091820)
Bayer's Contour Next USB
(K121087) |
| Meters supported by
the predicate device
but not by the current
device | GLUCOCARD: GLUCOCARD® 01,
GLUCOCARD® VitalTM
ReliOn: ReliOn® Confirm, ReliOn®
Prime
iSENS: CareSens N and CareSens
N POP | |
| Operating System | iOS 5.0 and higher | Android OS 2.3.3 or higher |
| Product | Glooko Device System for Glooko
Logbook+ Application
K130886
(Predicate Device) | Glooko Device System for
Glooko Application
K132272
(Subject Device) |
| Hardware | • iPod touch®: 3rd and 4th
generations
• iPhone®: 3GS, 4, 4S
• iPad®: iPad 1, iPad 2, and iPad
(3rd generation) -(Accessed in 2x
mode)
• iPod touch 5th generation, iPhone
5, iPad mini, and iPad 4th
generation (These devices require
Apple's off-the-shelf Lightning to 30-
pin adapter for connection.)* | • HTC Desire HD (A9191), HTC
Evo (PC36100), HTC Incredible
S S710e
• LG Nexus 4, LG Optimus 2X
(LG-P990)
• Motorola DROID X
• Samsung Ace (GT-S5830T),
Samsung Galaxy Nexus,
Samsung Galaxy Note (GT-
N7000), Samsung Galaxy Note
II (GT-N7100); Samsung
Galaxy S+ (GT-I9001),
Samsung Galaxy S II (GT-
I9100), Samsung Galaxy S II
(SGH-I757M), Samsung
Galaxy S III (GT-I9300),
Samsung Galaxy SIIII (GT-
I9500) |
| Syncs with compatible
meters | Yes | Yes |
| Allow users to annotate
readings with notes | Yes | Yes |
| Provide multiple view
options for the data | Yes | Yes |
| Share the collected
data | Yes | Yes |
| Provide statistics | Yes, across multiple devices and
supported web browsers. | Yes, across multiple devices and
supported web browsers. |
| Graph the glucose
readings | Yes, across multiple devices and
supported web browsers. | Yes, across supported web
browsers. |
| Allow goals to be set | Yes | No |
| Transmit and view data
across supported
multiple devices and
web browsers using
consistent
authentication
credentials
(username/password) | Yes | Yes |
COMPANY CONFIDENTIAL DO NOT COPY
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Image /page/5/Picture/0 description: The image shows the word "glooko" in a stylized, handwritten font. The letters are bold and black, with a slight shadow effect that gives them a three-dimensional appearance. The word is slightly curved, with the "g" and "o" at the ends being slightly higher than the letters in the middle.
Glooko Device system for Glooko Application
Special 510(k) Submission
K132272
Page 6 of 7
.
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Glooko Device system for Glooko Application Special 510(k) Submission K132272 Page 7 of 7
Intended Use:
The Glooko device system for Glooko Application is data management software intended for use in home and professional settings to aid individuals with diabetes and their healthcare professionals in review, analysis and evaluation of blood glucose readings to support an effective diabetes management program. The Glooko device system for Glooko Application connects to compatible FDA cleared meters and allows users to transfer their blood glucose meter results to their mobile devices running on Android operating system.
The Glooko device system for Glooko Application is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
Summary of Testing:
The Glooko Application underwent verification and validation testing. A brief summary of the tests performed is described below. These studies demonstrated that the Glooko Device System for Glooko Application performed according to the specifications and the intended use.
Software Verification and Validation
-
The Glooko Device system (Glooko Application, and Cable) was validated pursuant to the moderate level of concern requirements. Design validation testing confirmed that the Glooko device performs according to the stated intended use. Device evaluation consisted of functional testing performed pursuant to Glooko's design verification protocol, which referenced FDA's guidance document for medical devices containing software. Such testing included Data Integrity Verification, Software Design/features Verification, and error handling testing. All test results fell within the pre-determined specification parameters.
Statement of Equivalence:
The Glooko Device System for Glooko Application is substantially equivalent to the predicate device with regards to its intended use and function. Both the subject and predicate devices use the exact same technology to download data from compatible FDA cleared blood glucose meters. Both the subject and predicate device are able to analyze blood glucose meter data producing basic statistics and graphs.
Summary:
Based on the information provided in this premarket notification, the Glooko device system for Glooko Application is substantially equivalent to the predicate device and is suitable for its intended use.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services (USA). The logo features the department's name arranged in a circular fashion around the perimeter. In the center of the circle is the department's symbol, which consists of a stylized caduceus-like design with three wavy lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2013
Glooko, Inc. c/o Shilpa Mydur 170A University Avenue PALO ALTO CA 94301
Re: K132272
Trade/Device Name: Glooko Device System for Glooko Application Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, JOP Dated: September 16, 2013 Received: September 17, 2013
Dear Shilpa Mydur:
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 Parts 801 and 809); 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.
8
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/ResourcesforYou/Industry/default.htm. 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/MedicalDeviccs/Resourcesfor You/Industry/default.htm.
Sincerely yours.
CarolGBenson -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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510(k) Number if Known: N/A
Device Name: Glooko Device System for Glooko Application
Indications for Use:
The Glooko device system for Glooko Application is data management software intended for use in home and professional settings to aid individuals with diabetes and their health care professionals in review, analysis and evaluation of blood glucose readings to support an effective diabetes management program. The Glooko device system for Glooko Application connects to compatible FDA cleared meters and allows users to transfer their blood glucose meter results to their mobile devices running on Android Operating System.
The Glooko device system for Glooko Application is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Stayce Beck
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k)