Who is the manufacturer of GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION?

Glooko, Inc. filed the 510(k) submission for GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION (K132272).

What is the FDA product code for GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION?

NBW. It is classified under 21 CFR 862.1345 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION

K132272 · Glooko, Inc. · NBW · Oct 17, 2013 · Clinical Chemistry

Device Facts

Record ID	K132272
Device Name	GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION
Applicant	Glooko, Inc.
Product Code	NBW · Clinical Chemistry
Decision Date	Oct 17, 2013
Decision	SESE
Submission Type	Special
Regulation	21 CFR 862.1345
Device Class	Class 2
Attributes	Software as a Medical Device

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.

Device Story

System aids diabetes management by downloading, reviewing, and analyzing blood glucose data. Inputs: blood glucose readings from compatible, FDA-cleared commercial meters. Hardware: MeterSync Cable (with integrated IR adapter) connects meter to Android mobile device (3.5mm jack or IR). Software: Glooko Application on Android OS; collects/stores historical data; allows user-generated notes/meal tags; generates graphs and statistics. Used in home or professional settings by patients or clinicians. Output: visual display of glucose trends, statistics, and logs on mobile device or web browser. Facilitates data sharing between patient and healthcare provider. Does not provide treatment decisions.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements; no clinical data provided.

Technological Characteristics

System consists of MeterSync Cable (with integrated IR adapter) and Android-based software. Connectivity: 3.5mm audio jack or IR interface to blood glucose meters; USB OTG for specific models. Software: Android OS 2.3.3+. Data transmission: local download to mobile device, sync to web browser via authentication. Sterilization: N/A.

Indications for Use

Indicated for patients with diabetes requiring blood glucose monitoring; intended to facilitate data transfer and viewing from glucose meters to mobile devices.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Glooko Device System for Glooko Logbook+ Application (k130886)

Related Devices

K122142 — GLOOKO LOGBOOK CHARTS · Glooko, Inc. · Dec 21, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Ki32272 Image /page/0/Picture/1 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, adding to the playful and informal feel of the design. 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}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the word "glooko" in a stylized, bold font. The letters are connected and have a shadow effect, giving them a three-dimensional appearance. The word is written in lowercase, and the overall design is playful and eye-catching. 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 - 1. The Glooko MeterSync Cable for Android - 2. 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 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "glooko" in a stylized, bold font. The letters are connected and have a slightly rounded appearance. The word is written in black against a white background. 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 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "glooko" in a stylized, handwritten font. The letters are bold and black, with a slightly uneven outline that gives them a hand-drawn appearance. The word is presented in a slightly curved manner, adding to the playful and informal aesthetic. 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}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "glooko" in a stylized, handwritten font. The letters are bold and black, with a white outline that gives them a slightly three-dimensional appearance. The word appears to be a logo or brand name. --- 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 {5}------------------------------------------------ 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 . {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "glooko" in a stylized, handwritten font. The letters are bold and black, with a white outline that gives them a slightly three-dimensional appearance. The word is slightly curved, with the letters appearing to lean slightly to the right. 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 {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the word "glooko" in a stylized, handwritten font. The letters are bold and black, with a slight outline effect that gives them a three-dimensional appearance. The word appears to be a logo or brand name, possibly for a product or company. K132212 # 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)