(284 days)
GoChek Blood Glucose Monitoring System
The GoChek Blood Glucose Monitoring System comprises of the GoChek Blood Glucose Meter and GoChek Blood Glucose Test Strips. The GoChek Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. The GoChek Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. The GoChek Blood Glucose Monitoring System is intended for single-patient use and should not be shared.
The GoChek Blood Glucose Monitoring System is for in vitro diagnostic use. The GoChek Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes.
GoChek Connect Blood Glucose Monitoring System
The GoChek Connect Blood Glucose Monitoring System comprises of the GoChek Connect Blood Glucose Meter and GoChek Blood Glucose Test Strips. The GoChek Connect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. The GoChek Connect Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. The GoChek Connect Blood Glucose Monitoring System is intended for single-patient use and should not be shared.
The GoChek Connect Blood Glucose Monitoring System is for in vitro diagnostic use. The GoChek Connect Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes.
GoChek Blood Glucose Monitoring System and GoChek Connect Blood Glucose Monitoring System (also called "GoCheck series") perform quantitative assays of glucose in fresh capillary whole blood obtained from the fingertip. The glucose measurement is achieved by using the amperometric detection method.
Both the systems share the same GoChek Blood Glucose test strips. It has a reagent system in test window that includes glucose dehydrogenase (FAD-GDH) and a mediator that reacts with the glucose in the whole blood sample. This reaction, in turn produces an electrical current that is measured by the meter's electronics through test strip contact area. The meter, then calculates and displays the blood glucose concentration reading, calibrated to a plasma reference.
GoChek Connect Blood Glucose Monitoring System has Bluetooth and serial interfaces that comply with US federal guidelines, Part 15 of the FCC Rules for devices with RF capability. This Bluetooth function will allow user to transfer their test results from BG meter to a specific app which developed by MicroTech. Users can choose to utilize these function by following the instruction to set it up, otherwise these functions will remain shut off.
Here's an analysis of the acceptance criteria and study findings for the GoChek Blood Glucose Monitoring System, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for accuracy are derived from the "FDA Guidance for Industry and Food and Drug Administration Staff Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use, October 2016." The study reported results indicating the device meets these criteria.
| Acceptance Criteria (from FDA Guidance) | Reported Device Performance (GoChek Series) |
|---|---|
| 95% of results within +/- 15% of comparator | 95% of all SMBG results are within +/- 15% of the comparator results |
| 99% of results within +/- 20% of comparator | 99% of all SMBG results are within +/- 20% of the comparator results |
Note: The reported performance is stated to be "across the entire claimed measuring range of the device," which is 10-580 mg/dL.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Method Comparison/User Evaluation were conducted with lay persons (including naïve and non-naïve SMBG users) using the GoChek series." However, it does not specify the exact sample size of lay persons or the number of blood samples collected for the primary method comparison/user evaluation.
For the laboratory setting study conducted for extreme glucose concentrations, the document also does not specify the sample size used, only that "studies using blood samples in the extreme upper and lower ends of the claimed measuring range (10 to 580 mg/dL) altered to achieve glucose concentrations of less than 80 mg/dL and greater than 250 mg/dL was performed."
The data provenance is not explicitly stated in terms of country of origin, but the manufacturer is MicrotechMedical (Hangzhou) Co., Ltd in China. The studies are described as "non-clinical tests" and "method comparison/user evaluation," implying prospective data collection during the development and validation phase of the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document states the comparator used for determining ground truth was the YSI Model 2300 STAT PLUS. This is a laboratory reference instrument, not human experts. Therefore, no information is provided about the number or qualifications of experts for establishing ground truth from this source.
4. Adjudication Method for the Test Set
No adjudication method is mentioned because the ground truth was established by a reference laboratory instrument (YSI Model 2300 STAT PLUS), not through expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The device is a Blood Glucose Monitoring System, which does not involve human readers interpreting images or data in a comparative effectiveness study with and without AI assistance in the way clinical imaging devices might. The user evaluation involves lay persons operating the device, but it's not described as an MRMC study to compare human interpretation with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study was clearly done. The "Method Comparison/User Evaluation" and the "studies using blood samples in the extreme upper and lower ends of the claimed measuring range" directly assessed the GoChek series (the algorithm and device) itself against a reference method (YSI Model 2300 STAT PLUS) to determine its accuracy. This is a direct measure of the device's inherent performance.
7. Type of Ground Truth Used
The ground truth used was reference laboratory measurement from the YSI Model 2300 STAT PLUS.
8. Sample Size for the Training Set
The document does not specify a sample size for a training set. This is common for predicate-based 510(k) submissions for devices like blood glucose meters, where the focus is on validation rather than demonstrating the performance of a machine learning algorithm that requires a distinct training phase. These devices are typically developed using established electrochemical principles rather than AI/ML techniques requiring large training datasets.
9. How the Ground Truth for the Training Set Was Established
As no specific training set is mentioned in the context of AI/ML, there is no information on how its ground truth was established. The device likely relies on a fixed algorithm based on the FAD-GDH enzyme and amperometric detection method described, rather than a machine learning model that needs to be "trained."
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out to the right of the square.
September 11, 2020
MicroTech Medical, Inc. % Mingzi Hussey Principal Regulatory Consultant Zi-Medical, Inc 253 Summer St Somerville, MA 02143
Re: K193340
Trade/Device Name: GoChek Blood Glucose Monitoring System GoChek Connect Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: August 11, 2020 Received: August 12, 2020
Dear Mingzi Hussey:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193340
Device Name GoChek Blood Glucose Monitoring System
Indications for Use (Describe)
GoChek Blood Glucose Monitoring System
The GoChek Blood Glucose Monitoring System comprises of the GoChek Blood Glucose Meter and GoChek Blood Glucose Test Strips. The GoChek Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. The GoChek Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. The GoChek Blood Glucose Monitoring System is intended for single-patient use and should not be shared.
The GoChek Blood Glucose Monitoring System is for in vitro diagnostic use. The GoChek Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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:
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Indications for Use
510(k) Number (if known) K193340
Device Name
GoChek Connect Blood Glucose Monitoring System
Indications for Use (Describe)
GoChek Connect Blood Glucose Monitoring System
The GoChek Connect Blood Glucose Monitoring System comprises of the GoChek Connect Blood Glucose Meter and GoChek Blood Glucose Test Strips. The GoChek Connect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. The GoChek Connect Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. The GoChek Connect Blood Glucose Monitoring System is intended for single-patient use and should not be shared.
The GoChek Connect Blood Glucose Monitoring System is for in vitro diagnostic use. The GoChek Connect Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Registration Use (Part 21 CFR 201.1 Subpart D) |
|---|
| Over-The-Counter Use (Part 21 CFR 201.66 Subpart C) |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | 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 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."
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GENERAL INFORMATION
1. Type of Submission
Traditional 510(k) Submission 510(k) number: K193340 Submission date: 09/30/2019
2. Submitter/Manufacturer information
Submitter Name: MicroTech Medical, Inc. Address: 1999 S. Bascom Ave, Suite 700, Campbell, CA 95008 Contact Person and Title: Dore Mark, Vice President Tel: +1408-5440744 Fax: +1408-5440744 Email: dore.mark@microtechmd.com
Manufacturer Name: MicrotechMedical(Hangzhou) Co.,Ltd Address:No.9 Haishu Road, Yuhang district, Hangzhou, Zhejiang 311121 China Contact Person and Title: Weiwei Zhu /RA Manager Tel: 0086- 88566372-809 Fax: 0086-88566539 Email: weiwei.zhu@microtechmd.com
3. Contact person
3.1 Primary Contact Person
Mingzi Hussey Principal Regulatory Consultant at Zi-medical Address: 253 Summer St, Somerville, MA 02143 Phone: +1 206-981-0675 Email: mingzi@zi-medical.com
3.2Secondary Contact Person
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Dore Mark Vice President at MicroTech Medical,Inc. Address: 1999 S. Bascom Ave, Suite 700, Campbell, CA 95008 Contact Person and Title: Dore Mark, Vice President Tel: +1408-5440744 Email: dore.mark@microtechmd.com
4. Proprietary Name of the device
GoChek Blood Glucose Monitoring System GoChek Connect Blood Glucose Monitoring System
5. Common Name
Glucose Test System
6. Classification
Product code:NBW Class: II Regulation number: 862.1345 Glucose Test System
7. Predicate device
On Call Sharp Blood Glucose Monitoring System ACON Laboratories, Inc. 510(k) number: K130284
8. Device information
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Device name: GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring Systems
| ProprietaryName | ModelNo. | Classification | ProductCode | Description | CommonName |
|---|---|---|---|---|---|
| GoChek BloodGlucoseMonitoringSystem | GoChek | 862.1345Class II | NBW | System, Test, BloodGlucose, Over TheCounter | GlucoseTestSystem |
| GoChek ConnectBlood GlucoseMonitoringSystem | GoChekConnect | 862.1345Class II | NBW | System, Test, BloodGlucose, Over TheCounter, Blue-Tooth | GlucoseTestSystem |
9. Description
Image /page/6/Figure/4 description: The image shows a GoChek blood glucose meter. The meter has a screen in the center and three buttons below it. The buttons are labeled with a left arrow, the letter 'M', and a right arrow.
Image /page/6/Figure/5 description: The image shows a GoChek Connect blood glucose meter. The meter has a screen at the top and three buttons labeled '<', 'M', and '>' below the screen. The meter is white and has a rounded shape.
GoChek Blood Glucose meter Monitoring System
GoChek Connect Blood Glucose meter Monitoring System
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GoChek Blood Glucose Monitoring System and GoChek Connect Blood Glucose Monitoring System (also called "GoCheck series") perform quantitative assays of glucose in fresh capillary whole blood obtained from the fingertip. The glucose measurement is achieved by using the amperometric detection method.
Both the systems share the same GoChek Blood Glucose test strips. It has a reagent system in test window that includes glucose dehydrogenase (FAD-GDH) and a mediator that reacts with the glucose in the whole blood sample. This reaction, in turn produces an electrical current that is measured by the meter's electronics through test strip contact area. The meter, then calculates and displays the blood glucose concentration reading, calibrated to a plasma reference.
Image /page/7/Figure/3 description: This image shows a diagram of a test strip. The diagram labels the "Fingerhold Area" as the area to grip the strip. The "Sample Area" is labeled as the area to apply blood or control solution. The "Contacts" are labeled as the side to insert into the test strip port.
GoChek Connect Blood Glucose Monitoring System has Bluetooth and serial interfaces that comply with US federal guidelines, Part 15 of the FCC Rules for devices with RF capability. This Bluetooth function will allow user to transfer their test results from BG meter to a specific app which developed by MicroTech. Users can choose to utilize these function by following the instruction to set it up, otherwise these functions will remain shut off.
Pancares App
The Pancares App is available for both Android phones (through Google Play). The app uses the smartphone'sbluetooth radio to read data from the GoChek Connect meter's onboardmemory. Once the device wireless connection and app are connected, thedevice sends the glucose data and synchronizes the onboard history with theapp and allows the app to display this data for the user. The data that is
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transferred to the smartphone is read only, and the smartphone has no way of altering the data residing on the GoChek Connect meter.
10.Intended Use/ Indications for Use
GoChek Blood Glucose Monitoring System
The GoChek Blood Glucose Monitoring System comprises of the GoChek Blood Glucose Meter and GoChek Blood Glucose Test Strips. The GoChek Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. The GoChek Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. The GoChek Blood Glucose Monitoring System is intended for single-patient use and should not be shared.
The GoChek Blood Glucose Monitoring System is for in vitro diagnostic use. The GoChek Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes.
GoChek Connect Blood Glucose Monitoring System
The GoChek Connect Blood Glucose Monitoring System comprises of the GoChek Connect Blood Glucose Meter and GoChek Blood Glucose Test Strips. The GoChek Connect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. The GoChek Connect Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. The GoChek Connect Blood Glucose Monitoring System is intended for single-patient use and should not be shared. The GoChek Connect Blood Glucose Monitoring System is for in vitro diagnostic use. The GoChek Connect Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes.
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11.Technological Characteristics
Specification of the GoChek Blood Glucose Monitoring System and GoChek Connect Blood Glucose Monitoring System:
| Feature | Specification |
|---|---|
| Size | 83.5mm (L) x 54mm (W) x19mm (Thickness) |
| Glucose Test Range | 10-580 mg/dL |
| Results Display | Plasma equivalent |
| Minimum SampleVolume | 0.5uL |
| Test Time | 5 seconds |
| Battery | CR 2032 3.0V coin cell battery |
| Battery life | >1,000 readings |
| Glucose ConcentrationUnits | mg/dL |
| Memory Storage | 500 test results with date and time |
| Auto Shutdown | Automatic shutdown after 2 minutes |
| Display Size | 40mm× 42mm |
| Weight | about 50 grams (including battery) |
| Operating Temperature | 41-113°F (5-45°C) |
| Operating Humidity | 10-90% (non-condensing) |
| Hematocrit Range | 10-70% |
| Sample | Fresh capillary whole blood |
| Sample Site | Fingertip |
| Data Port | Serial data port |
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12.Comparison to Predicate Devices
Predicate Device:
On Call Sharp Blood Glucose Monitoring System 510(k) Number: K130284
| Features | GoChek/GoChek Connect BloodGlucose Monitoring System | On Call Sharp Blood GlucoseMonitoring System (K130284) |
|---|---|---|
| Indicationsfor Use | The GoChek Blood GlucoseMonitoring System comprises ofthe GoChek Blood GlucoseMeter and GoChek BloodGlucose Test Strips. TheGoChek Blood GlucoseMonitoring System is intended tobe used for the quantitativemeasurement of glucose in freshcapillary whole blood from thefingertips. The GoChek BloodGlucose Monitoring System isintended for self-testing bypeople with diabetes at home asan aid in monitoring theeffectiveness of diabetes controlprograms. The GoChek BloodGlucose Monitoring System isintended for single-patient useand should not be shared.The GoChek Blood GlucoseMonitoring System is for in vitrodiagnostic use. The GoChekBlood Glucose MonitoringSystem is not intended for thediagnosis of or screening for | The On Call Sharp BloodGlucoseMonitoring System is anelectrochemical enzymaticassay for the quantitativedetection of glucose in freshcapillary whole blood from thefingertip, forearm, and palm bypeople with diabetes at homeas an aid in monitoring theeffectiveness of diabetescontrol programs. Forearmand palm testing sites shouldbe used alternately only whenblood glucose level is notchanging rapidly. The On CallSharp Blood GlucoseMonitoring System is intendedto be used by a single patientand should not be shared. It isfor in vitro diagnostic use only. |
| diabetes. | ||
| DetectionMethod | Amperometric electrochemical | Same |
| Enzyme | Glucose Dehydrogenase (FAD-GDH) | Same |
| CalibrationCoding | no-coding | Same |
| Test Range | 10-580 mg/dL | 20 – 600 mg/dL |
| Memory | 500 records with time and date | Same |
| Sample Type | fresh capillary whole blood | Capillary whole blood |
| Sample Sites | Fingertip | Fingertip, forearm, palm |
| SampleVolume | 0.5µL | 0.6 μL |
| Sample TestTime | 5 seconds | Same |
| HematocritRange | 10 –70% | 25 – 70% |
| GlucoseUnits ofMeasure | mg/dL | mg/dL |
| OperatingTemperature | 41-113°F (5-45°C) | 50-113°F (10-45°C) |
| OperatingRelativeHumidity | 10–90% | Same |
| Data Port | Serial data port | Same |
| AutomaticShutoff | Two minutes after last user action | Same |
| PowerSource | Two CR 2032 3.0 V coin cell batteries | Two CR 2032 3.0V coin cell batteries |
| Meter Size | 83.5 x 54 x19mm | 90 x 58 x 22 mm |
| Meter Weight | Approx. 50 grams (including battery) | Approx. 50 g (including batteries |
| Battery Life | >1,000 readings | Minimum of 1,000measurements(without considering datatransfer and test reminderalarms) |
| Bluetooth(Only applyfor GoChekConnectBloodGlucoseMonitoringSystem) | BLE 4.0 version | None |
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13. Discussion of Non-Clinical Tests Performed for Determination of Substantial
Equivalence
13.1 Standard/Guidance Document Referenced
- · FDA Guidance for Industry and Food and Drug Administration Staff Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use, October 2016
- Review Criteria for Assessment of Portable Blood Glucose In Vitro Diagnostic ●
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Devices Using Glucose Oxidase, Dehydrogenase, or Hexokinase Methodology, April 2015
- . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 200521 CFR Part 803 : The Medical Device Reporting (MDR) Requlation, April 2018.General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 2002
- . CLSI/NCCLS EP06-A: Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
- CLSI/NCCLS EP07-A2: Interference Testing in Clinical Chemistry: Approved Guideline Second Edition
- . ISO 13485:2016: Medical devices - Quality management systems -Requirements for regulatory purposes
- EN 13532:2002: General requirements for in vitro diagnostic medical devices for self-testing
- EN 13612:2002/AC:2002: Performance evaluation of in vitro diagnostic medical . devices
- EN 13640:2002/EN 13640:2002: Stability testing of in vitro diagnostic reagents O
- EN 13641:2002: Elimination or reduction of risk of infection related to in vitro diagnostic reagents
- EN ISO 14971:2012: Medical devices Application of Risk management to ● medical devices
- EN ISO 15197:2015: In vitro diagnostic test systems - Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus
- EN ISO 15223-1:2016: Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2016-12-15)
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- EN ISO 17511:2003: In vitro diagnostic medical devices Measurement of ● quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials
- EN ISO 18113-1:2011: In vitro diagnostic medical devices. Information supplied . by the manufacturer (labeling). Part 1: Terms, definitions and general requirements
- . EN ISO 18113-2:2011: In vitro diagnostic medical devices. Information supplied by the manufacturer (labeling). Part 2: In vitro diagnostic reagents for professional use
- EN ISO 18113-3:2011: In vitro diagnostic medical devices. Information supplied . by the manufacturer (labeling). Part 3: In vitro diagnostic instruments for professional use
- EN ISO 18113-4:2011: In vitro diagnostic medical devices. Information supplied . by the manufacturer (labelinq). Part 4: In vitro diagnostic reagents for self-testing
- EN ISO 18113-5:2011: In vitro diagnostic medical devices. Information supplied by the manufacturer (labeling). Part 5: In vitro diagnostic instruments for selftesting
- EN 13640:2002: Stability testing of in vitro diagnostic reagents
- IEC 60068-2-64:2008: Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
- . IEC/EN 61010-1:2010: Safety requirements for electrical equipment for measurement, control and laboratory use. General requirements
- . IEC 61010-2-101:2015: Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
- EN 62366:2008: Medical devices. Application of usability engineering to medical o devices
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- IEC 60601-1-2:2014: International Standard: Medical electrical equipment Part . 1-2:General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances - Requirements and tests
- EN 62304:2006 / AC:2008: Medical device software. Software life-cycle . processes
- ASTM D 4169-09A: Standard Practice for Performance Testing of Shipping . Containers and Systems
- Council Directive 2002/95/EC: on Waste Electrical and Electronic Equipment ● (WEEE Directive)
- Council Directive 80/181/EEC of 20 December 1979: EU Metric Directive
- . Council Directive 1999/103/EC: amending council directive 80/181/ECC on the approximation of the laws of Member States relating to units of measurement
- Directive 2011/65/EU: on the restriction of the use of certain hazardous substances in electrical and electronic equipment
- . EN 50581:2012: Technical documentation for the assessment of electrical and electronic products with respect to the restriction of hazardous substances
- . IEC 62321:2008: Electrotechnical products - Determination of levels of six regulated substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, polybrominated diphenyl ethers)
13.2 Performance Testing
The performance characteristics of the GoChek Connect Blood Glucose Monitoring System were evaluated by performing the following studies: within-run precision, intermediate precision, Linearity, Interference Evaluation(Endogenous/Exogenous Substances), Hematocrit Effect, Stability, System Operating Conditions Testing Study, Temperature Effect Study for Control Solution , Flex Study using sample Outside the Measuring Range, Sample Volume, Sample Perturbation Study, Intermittent Sampling, software validation testing,
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electromagnetic compatibility, electrical safety testing, Random vibration test, Shock Testing and usability testing.
14. Discussion of Method Comparison/User Evaluation Performed
Method Comparison/User Evaluation were conducted with lay persons (including naïve and non-naïve SMBG users) using the GoChek series. .
The study data were presented evaluating the system accuracy of the GoChek series compared to the YSI Model 2300 STAT PLUS per the Microtech Method Comparison/User Evaluation Protocol for the GoChek/ GoChek Connect Blood Glucose Monitoring System.
In addition, studies using blood samples in the extreme upper and lower ends of the claimed measuring range (10 to 580 mg/dL) altered to achieve glucose concentrations of less than 80 mg/dL and greater than 250 mg/dLwas performed in a laboratory setting by trained professionals, wherein samples were measured and compared on both the GoChek series and YSI Model 2300 STAT PLUS. Both above study results indicate that 95% of all SMBG results are within +/- 15% of the comparator results across the entire claimed measuring range of the device and
that 99%of all SMBG results are within +/- 20% of the comparator results across the entire claimed measuring range of the device.
In addition, the participants in Method Comparison/User Evaluation were questioned and assessed the readability grade level of the user manual, test strip insert, and control solution insert prior to study.
15. Substantial Equivalence Conclusion
The laboratory testing and Method Comparison/User Evaluation study results demonstrate that the GoChek Connect Blood Glucose Monitoring System is safe, effective and convenient. It also demonstrates that the GoChek/GoChek Connect Blood Glucose Monitoring System meets the accuracy requirements per Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use-Guidance for Industry and Food and Drug Administration Staff. October 11, 2016, and as such is
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substantially equivalent to the On Call Sharp Blood Glucose Monitoring System. currently sold on the U.S. market(K130284).
The information provided in the 510(k) submission is sufficient to demonstrate the substantial equivalence of subject device to the predicate device.
§ 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.