IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 8, 2014 EOSHEALTH, INC. CARRIE HETRICK SENIOR CONSULTANT, RA, C/O EMERGO GROUP 816 CONGRESS AVE, STE 1400 AUSTIN, TX 78701 Re: k133584 Trade/Device Name: In Touch Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA, JJX Dated: August 26, 2014 Received: August 27, 2014 Dear Ms. Hetrick: 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. {1}------------------------------------------------ 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. # Courtney 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) k133584 Device Name In Touch® Blood Glucose Monitoring System #### Indications for Use (Describe) The In Touch® Blood Glucose Monitoring System (In Touch® BGMS) is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in fresh whole capillary blood from the fingertip. It is intended for use by people with diabetes mellitus at home as an aid to monitor the effectiveness of diabetes control program. The In Touch® BGMS is for in vitro diagnostic use only and should not be used for the diagnosis of /or screening for diabetes mellitus or neonatal use. The In Touch® BGMS is intended to be used by a single person and should not be shared. The In Touch® Blood Glucose Test Strips (In Touch® strips) are used with the In Touch® Blood Glucose Meter (In Touch® meter) in the quantitative measurement of glucose in fresh capillary blood from the fingertip. The In Touch® Control Solution is for use with the In Touch® strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly. Type of Use (Select one or both, as applicable) - Prescription Use (Part 21 CFR 801 Subpart D) > Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {3}------------------------------------------------ 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 PRAStaff@fda.hhs.gov "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." {4}------------------------------------------------ # 510(k) Summary ## for # In Touch® Blood Glucose Monitoring System ## 1. Submission Submitter EosHealth, Inc. Williams Tower, 41st Floor 2800 Post Oak Boulevard Houston, Texas 77056 USA Phone: +1 (866) 435.5643 Email: https://www.eoshealth.com Contact: Kimon Angelides, Chief Scientific Officer ## 2. Submission Correspondent Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: +1 (720) 838.4113 Office Phone: +1 (512) 327.9997 Fax: +1 (512) 327.9998 Contact: Carrie Hetrick, Senior Consultant, RA Email: project.management@emergogroup.com ## 3. Date Prepared September 4, 2014 ## 4. Proprietary and Established Names In Touch® Blood Glucose Monitoring System ## 5. Regulatory Information | Trade / Proprietary<br>Name | Classification | Regulation<br>Section | Product Code | Panel | |--------------------------------------------------------------|----------------|-----------------------|-------------------------------------------------------|-------------------------------| | In Touch® Blood Glucose<br>Monitoring System | Class II | 21 CFR §<br>862.1345 | NBW; System, Test, Blood<br>Glucose, Over The Counter | Clinical<br>Chemistry<br>(75) | | In Touch® Blood Glucose<br>Meter (In Touch® Meter) | Class II | 21 CFR §<br>862.1345 | NBW; System, Test, Blood<br>Glucose, Over The Counter | Clinical<br>Chemistry<br>(75) | | In Touch® Blood Glucose<br>Test Strips (In Touch®<br>Strips) | Class II | 21 CFR §<br>862.1345 | CGA; Glucose Oxidase,<br>Glucose | Clinical<br>Chemistry<br>(75) | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {5}------------------------------------------------ | Trade / Proprietary<br>Name | Classification | Regulation<br>Section | Product Code | Panel | |-------------------------------|----------------|-----------------------|------------------------------------------------------------------------|-------------------------------| | In Touch® Control<br>solution | Class I | 21 CFR §<br>862.1660 | JJX; Single (Specified)<br>Analyte Controls (Assayed<br>And Unassayed) | Clinical<br>Chemistry<br>(75) | ## 6. Indication for Use Statement The In Touch® Blood Glucose Monitoring System (In Touch® BGMS) is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in fresh whole capillary blood from the fingertip. It is intended for use by people with diabetes mellitus at home as an aid to monitor the effectiveness of diabetes control program. The In Touch® BGMS is for in vitro diagnostic use only and should not be used for the diagnosis of /or screening for diabetes mellitus or neonatal use. The In Touch® BGMS is intended to be used by a single person and should not be shared. The In Touch® Blood Glucose Test Strips (In Touch® strips) are used with the In Touch® Blood Glucose Meter (In Touch® meter) in the quantitative measurement of glucose in fresh capillary blood from the fingertip. The In Touch® Control Solution is for use with the In Touch® meter and In Touch® strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly. ## 7. Device Description The EosHealth, Inc. In Touch® BGMS, is an Over-The-Counter (OTC) system designed for the self-monitoring of blood glucose by persons with diabetes in home settings to aid in their diabetes management. The system consists of the following components: - In Touch® Blood Glucose Meter (In Touch® meter) - In Touch® Blood Glucose Test Strips ● - In Touch® Lancing Device ● - In Touch® Lancets ● - In Touch® Level 1 Control Solution - In Touch® Level 2 Control Solution - AC Adapter (wall charger) and USB Charger - Carrying Case - . In Touch® Data Management System (optional accessory to the In Touch® BGMS) The In Touch® meter is an Over-The-Counter (OTC), handheld device that along with the primary components of the system, monitors glucose in the blood to help with the management and treatment of diabetes. The In Touch® meter also incorporates additional features to aid in self-monitoring of blood glucose including tables and logs, graphs, and a pedometer. The test principle is based on electrochemical biosensor technology and the principle of capillary action. The electrical current generated by the reaction of glucose with the reagent of the strip is measured by the meter and is displayed as the corresponding blood glucose {6}------------------------------------------------ level. The strength of the current produced by the reaction depends on the amount of glucose in the blood sample. These blood glucose measurements are obtained through the use of disposable test strips. These blood glucose levels are displayed on the screen and stored in In Touch® meter's memory. In addition to the immediate read-out on In Touch® meter's display, the readings can also be transmitted securely over the GSM cellular network to a secure server. The use on the GMS connection also provides the ability for direct feedback from the server to the In Touch® meter. ## 8. Legally Marketed Predicate Device(s) ACON Laboratories, Inc. On Call® Vivid Blood Glucose Monitoring System, 510(k) Number k112653 ACON Laboratories, Inc. On Call® Diabetes Management Software, 510(k) Number k101371 ## 9. In Touch® Substantial Equivalence Discussion The comparison chart below provides information to demonstrate the substantial equivalence between the In Touch® Blood Glucose Monitoring System to the predicate device, the ACON On Call® Vivid Blood Glucose Monitoring System (k112653) with respect to intended use, technological characteristics, and principles of operation. | Comparator | EosHealth, Inc. | ACON Laboratories, Inc. | |------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | In Touch® Glucose Monitoring System | On Call® Vivid Glucose Monitoring System | | 510(k) Number | k133584 | k112653 | | Product Code | NBW - System, Test, Blood Glucose, Over the Counter | NBW - System, Test, Blood Glucose, Over the Counter | | Regulation Number | 21 CFR § 862.1345 | 21 CFR § 862.1345 | | Panel | Clinical Chemistry (75) | Clinical Chemistry (75) | | Over-the-Counter (OTC) and/or Rx | OTC | OTC | | Indications for Use | The In Touch® Blood Glucose Monitoring System (In Touch® BGMS) is an over-the-counter (OTC) device utilized by persons with diabetes in home settings for the quantitative measurement of glucose in fresh whole capillary blood from the fingertip. It is intended for use by people with diabetes mellitus at home as an aid to monitor the effectiveness of diabetes control program. The In Touch® BGMS is for in vitro diagnostic use only and should not be used for the diagnosis of /or screening for diabetes mellitus or neonatal use. The In Touch® BGMS is intended to be used by a single person | The On Call® Vivid Blood Glucose Monitoring System uses an electrochemical enzymatic assay for the quantitative detection of glucose in fresh capillary whole blood from the fingertip, forearm, and palm by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternate testing sites (forearm and palm) should be used only during steady-state times (when blood glucose level is not changing rapidly). The On Call®) Vivid Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing | | Comparator | EosHealth, Inc. | ACON Laboratories, Inc. | | | and should not be shared. | multiple patients. It is for in vitro<br>diagnostic use only. | | | | The On Call® Vivid Blood Glucose<br>Monitoring System should not be used for<br>the diagnosis of or screening for diabetes<br>mellitus or neonatal use. | | | The In Touch® Blood Glucose Test Strips<br>(In Touch® strips) are used with the In<br>Touch® Blood Glucose Meter (In Touch®<br>meter) in the quantitative measurement<br>of glucose in fresh capillary blood from<br>the fingertip. | The On Call® Vivid Blood Glucose Test<br>Strips are used with the On Call Vivid<br>Blood Glucose Meter in the quantitative<br>measurement of glucose in fresh capillary<br>blood from the fingertip, forearm, and<br>palm. | | | The In Touch® Control Solution is for use<br>with the In Touch® meter and In Touch®<br>strips as a quality control check to verify<br>that the meter and test strips are working<br>together properly and that the test is<br>performing correctly. | The On Call® Vivid Blood Glucose Control<br>Solution is for use with the On Call® Vivid<br>Blood Glucose Meter and Test Strips as a<br>quality control check to verify that the<br>meter and test strips are working together<br>properly and that the test is performing<br>correctly. | | Intended Users | Adults and Children | Adults and Children | | Blood Glucose<br>Meter | In Touch® meter | On Call® Vivid meter | | Test Strip | In Touch® Blood Glucose Test Strip* | ACON On Call® Vivid Blood Glucose Test<br>Strip (k112653) | | Control<br>Solution | In Touch® Level 1 and Level 2 Control<br>Solution* | On Call® Level 1 and Level 2 Control<br>Solution | | AC Adapter | AC Adapter (wall charger)** | None | | USB Charger | USB Charger** | None | | Carrying Case | Carrying Case** | Carrying Case | | Technical<br>Support | Yes | Yes | | User's Manual | Available on Internet while using program | Available on Internet while using program | | Glucose<br>Methodology | Electrochemical enzymatic assay, Glucose<br>Oxidase | Electrochemical enzymatic assay, Glucose<br>Oxidase | | Glucose Test<br>Results | mg/dL (Plasma values) | mg/dL (Plasma values) | | Sample | Fresh Capillary whole blood | Fresh capillary whole blood | | Blood Source | Fingertip | Fingertip, Forearm, Palm | | Glucose<br>Minimum<br>Sample<br>Volume | 0.8 μL | 0.8 μL | | Glucose Test<br>Range | 20 to 600 mg/dL (1.1-33.3 mmol/L) | 20 to 600 mg/dL (1.1-33.3 mmol/L) | | Length of Test | 5 seconds | 5 seconds | | Glucose Test<br>Strips Active<br>Reagent | Glucose Oxidase | Glucose Oxidase | | Test Strip<br>Calibration<br>Coding | No Code | No Code | | Comparator | EosHealth, Inc. | ACON Laboratories, Inc. | | Glucose Test<br>Imprecision | 6% or 5.4 mg/dL (whichever is greater)<br>CV @<75 mg/dL=4.59%; CV @>75 mg/dL<br>3.68% | 6% or 5.4 mg/dl (whichever is greater) | | Glucose Test<br>Linearity | From 20-600 mg/dL 95% CI, r2=0.9986;<br>mean slope 1.004±0.008 (95% CI),<br>intercept 2.36 | From 20-600 mg/dL 95% CI, r2=0.988;<br>mean slope 0.99, intercept 6.0 | | Glucose Test<br>Accuracy | <75 mg/dL 100% are within ±15 mg/dL;<br>>75 mg/dL 99.7% within ±15% | <75 mg/dL 100% are within ±15 mg/dL;<br>>75 mg/dL 100% within ±15% | | Acceptable<br>Hematocrit<br>Range | 20% to 70% | 20% to 70% | | Meter<br>Operating<br>Temperature | 41°F to 113°F (5°C to 45°C) | 41°F to 113°F (5°C to 45°C) | | Meter<br>Operating<br>Relative<br>Humidity | 10% to 90% non-condensing | 10% to 90% non-condensing | | Operating<br>Altitude | Up to 8,546 ft. (2,595 m) | Up to 8,546 ft. (2,595 m) | | Dimensions | 3.6 x 2.3 x 0.9 in (91.4 x 58.4 x 22.9 mm) | 3.58" x 2.28" x 0.83" | | Weight | 2.65 oz. (75 g) | Approximately 60 g (without battery<br>installed) | | Display<br>language | English | English | | Data display | Numerical & Icons | Numerical & Icons | | Display | Color LCD-Touch | B & W LCD | | Data Output<br>Port | GPRS Telit 865 QUAD GSM | USB, 9600 baud, 8 data bits, 1 stop bit, no<br>parity | | Monitor data<br>storage | 1000 results with time and date | 500 results with time and date | | Day average | 7-, 14-, 30-, 60-, 90- day average glucose<br>result | 7-, 14-, 30-, 60-, 90- day average glucose<br>result | | Insulin Logging | Yes | No | | Pedometer | Pedometer | Not applicable | | Battery Type | 3.7 Li-Polymer Battery 1100 mAh,<br>rechargeable, permanently installed | Two (2) CR 2032 3.0V coin cell batteries,<br>250 mA | | Battery Charge<br>Time | 2 hours | Not applicable | | Rated | IEC 61010-1, IEC 61010-2-101, IEC 61326 | IEC 61010-1, IEC 61010-2-101, IEC 61326 | | Test Strips<br>Storage<br>Temperature<br>Range | 41°F to 86°F (5°C to 30°C) | 41°F to 86°F (5°C to 30°C) | #### Table 1: Comparison of In Touch® Characteristics with Predicate Device {7}------------------------------------------------ {8}------------------------------------------------ The In Touch® Blood Glucose Monitoring System's Indications for Use statement is similar to the predicate device with minor variation. The device also has similar technological characteristics as the predicate device with minor variation. Both devices have similar firmware and utilize the same blood glucose test strips, lancing devices, lancets, and control solution. The data collection software functionality, communication method with data {9}------------------------------------------------ management software functionality, communication method with the central server, implementation method of collecting data from the test strips, monitor software, connectivity, and communication are similar to the predicate device with minor variation. The subject and predicate devices use exactly the same firmware embedded in the same microcontroll…