The GLUCOCARD Shine Express Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The GLUCOCARD Shine Express Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

The GLUCOCARD Shine Blood Glucose Test Strips are for use with the GLUCOCARD Shine Express Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

The GLUCOCARD Shine Connex Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The GLUCOCARD Shine Connex Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.

The GLUCOCARD Shine Blood Glucose Test Strips are for use with the GLUCOCARD Shine Connex Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.

Device Description

The GLUCOCARD Shine Connex Blood Glucose Monitoring System consist of a hand held GLUCOCARD Shine Connex Blood Glucose Meter, GLUCOCARD Shine Blood Glucose Test Strip, and GLUCOCARD Shine Glucose Control Solution. The GLUCOCARD Shine Express Blood Glucose Monitoring System consist of a hand held GLUCOCARD Shine Express Blood Glucose Meter, GLUCOCARD Shine Blood Glucose Test Strip, and GLUCOCARD Shine Glucose Control Solution. The two candidate test systems are derived from the same design platform as their predicate device, CareSens N Premier Blood Glucose Monitoring System/CareSens N Premier BT Blood Glucose Monitoring System (K170614). The candidate devices are modified versions of the predicate device to suit the market needs for test systems with Bluetooth and talking features. The GLUCOCARD Shine Connex Blood Glucose Meter is a Bluetooth meter, similar to the CareSens N Premier BT Blood Glucose Meter, whereas the GLUCOCARD Shine Express Blood Glucose Meter is enabled with a talking feature (English and Spanish).

Both candidate devices are used with the GLUCOCARD Shine Blood Glucose Test Strip and GLUCOCARD Shine Glucose Control Solution, which are the same in chemical composition, fundamental scientific technology, intended use and operating principle as with the components of the predicate device, cleared in K170614. The only difference between the test strip & control solution of the candidate device and the ones of the predicate device is the brand name.

AI/ML Overview

This is a medical device application for two blood glucose monitoring systems, GLUCOCARD Shine Connex and GLUCOCARD Shine Express. As such, the acceptance criteria are based on established performance standards for blood glucose meters, primarily ISO 15197:2013 or equivalent.

Here's an analysis of the provided text to fulfill your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format for accuracy or precision, nor does it provide specific numerical performance results for the new devices. However, it does refer to "pre-determined Pass/Fail criteria" and concludes that the device passed "all of the tests."

For blood glucose monitoring systems, a common standard for accuracy is ISO 15197:2013, which typically requires:

For glucose concentrations < 100 mg/dL: 95% of results must be within ±15 mg/dL of the reference method.
For glucose concentrations ≥ 100 mg/dL: 95% of results must be within ±15% of the reference method.

Given that this is a 510(k) submission and the device is deemed substantially equivalent, it implies that the device met similar, if not identical, criteria to its predicate device (CareSens N Premier BGMS/CareSens N Premier BT BGMS, K170614), which would have needed to meet such standards.

Inferred Table:

Acceptance Criteria (Typical for BGMS, e.g., ISO 15197:2013)	Reported Device Performance
Accuracy:
- 95% of results within ±15 mg/dL of reference for glucose < 100 mg/dL	"The device passed all of the tests based on pre-determined Pass/Fail criteria." (Implies meeting accuracy standards)
- 95% of results within ±15% of reference for glucose ≥ 100 mg/dL
Precision:
- Repeatability and intermediate precision within specified coefficients of variation (typically < 5%)	"The device passed all of the tests based on pre-determined Pass/Fail criteria." (Implies meeting precision standards)
Linearity: Across the intended measurement range (20-600 mg/dL)	"The device passed all of the tests based on pre-determined Pass/Fail criteria."
Interfering Substances: No significant interference from common substances (hematocrit, etc.)	"[Hematocrit range (%)] 15~65" (Suggests tested within this range)
Environmental Conditions: Performance maintained across operating temperature and humidity ranges	"[Operating Temperature] 42.8-111.2°F", "[Operating Humidity] 10~90%" (Suggests tested within these ranges)
Cleaning and Disinfection: Effectiveness and material compatibility after cycles	"Disinfection studies were performed... The results demonstrated complete inactivation of live virus... 260 each of cleaning and disinfection cycles... has no effect on the performance or the external materials."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for the clinical or analytical test set used for performance evaluation of the GLUCOCARD Shine Connex or GLUCOCARD Shine Express. It only mentions:

"Verification, validation and testing activities were conducted to establish the performance, functionality and liabilities of the modified devices."
"The device passed all of the tests based on pre-determined Pass/Fail criteria."

Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is typically not applicable for blood glucose monitoring systems. The "ground truth" for blood glucose measurements is established by a highly accurate laboratory reference method (e.g., YSI analyzer), not by expert consensus. Therefore, no "experts" in the human reviewer sense are used for establishing the ground truth.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable for blood glucose monitoring systems. The ground truth is determined by an objective, quantitative laboratory reference method, not by human adjudication of images or clinical cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What War the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. Blood glucose monitoring systems are standalone diagnostic devices and do not involve human "readers" interpreting results in a way that would necessitate an MRMC study or AI assistance. The device directly provides a numerical glucose value.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance evaluation performed for this device is a standalone performance assessment. Blood glucose meters are designed to provide a direct, quantitative glucose measurement without human interpretation or intervention in the measurement process itself. The "device performance" mentioned refers to the accuracy and precision of the meter and test strip system in autonomously measuring glucose.

7. The Type of Ground Truth Used

The ground truth for blood glucose monitoring systems is typically established using a laboratory reference method known for its high accuracy and precision, such as a YSI glucose analyzer, measuring glucose in plasma or whole blood. The document doesn't explicitly name the reference method used but this is the standard practice.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of device performance studies. Blood glucose monitoring systems are not typically developed using machine learning models that require distinct training sets for their primary measurement function. Their performance is validated through analytical and clinical studies.

9. How the Ground Truth for the Training Set Was Established

As explained in point 8, a "training set" in the machine learning sense is not applicable here. The ground truth for the validation of the device's accuracy would be established by the laboratory reference method, as described in point 7.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 1, 2018

i-SENS, Inc. Joon Ho Jung RA Team Senior Manager 43, Banpo-daero 82-gil, Seocho-gu Seoul, 06646 Korea

Re: K181273

Trade/Device Name: GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: October 2, 2018 Received: October 2, 2018

Dear Joon Ho Jung:

We have reviewed vour 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 Mav 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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Kellie B. Kelm -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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Indications for Use

510(k) Number (if known) K181273

Device Name

GLUCOCARD Shine Express Blood Glucose Monitoring System

Indications for Use (Describe)

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)

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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Indications for Use

510(k) Number (if known) K181273

Device Name

GLUCOCARD Shine Connex Blood Glucose Monitoring System

Indications for Use (Describe)

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)

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.

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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Image /page/4/Picture/0 description: The image shows the logo for i-sens. The logo is blue, except for a green dot above the "i". The text is sans-serif and bolded.

i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea Tel: +82-2-916-6191 Fax: +82-2-942-2514

K181273 510(k) Summary

(As required by 21 CFR 807.92)

Introduction:	This summary of 510(k) information is being submitted in accordancewith requirements of 21 CFR Part 807.92.
Type of 510(k):	Special 510(k)
Submitter Information:	i-SENS, Inc.43, Banpo-daero 28-gil, Seocho-gu, Seoul, KoreaTel.) +82-2-910-0453Fax) +82-2-942-2514e-mail: jhjung@i-sens.comContact Person: Joon Ho Jung
Prepared Date:	April 25th, 2017
Device Name	GLUCOCARD Shine Connex Blood Glucose Monitoring SystemGLUCOCARD Shine Express Blood Glucose Monitoring System
Classification Name	Blood Glucose Test System

Product Code	Classification	Regulation Section	Panel
NBW	Class II	21 CFR 862.1345	Clinical Chemistry 75
		Blood Glucose Test System

Predicate Device CareSens N Premier Blood Glucose Monitoring System/CareSens N Premier BT Blood Glucose Monitoring System, K170614.

Device Description The GLUCOCARD Shine Connex Blood Glucose Monitoring System consist of a hand held GLUCOCARD Shine Connex Blood Glucose Meter, GLUCOCARD Shine Blood Glucose Test Strip, and GLUCOCARD Shine Glucose Control Solution. The GLUCOCARD Shine Express Blood Glucose Monitoring System consist of a hand held GLUCOCARD Shine Express Blood Glucose Meter, GLUCOCARD Shine Blood Glucose Test Strip, and GLUCOCARD Shine Glucose Control Solution. The two candidate test systems are derived from the same design platform as their predicate device, CareSens N Premier Blood Glucose Monitoring System/CareSens N Premier BT Blood Glucose Monitoring System (K170614). The candidate devices are modified versions of the predicate device to suit the market needs for test systems with Bluetooth and talking features. The GLUCOCARD Shine Connex Blood Glucose Meter is a Bluetooth meter, similar to the CareSens N Premier BT Blood Glucose Meter, whereas the GLUCOCARD Shine Express Blood Glucose Meter is enabled with a talking feature (English and Spanish).

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Image /page/5/Picture/0 description: The image shows the logo for i-sens. The "i" is blue with a green dot above it. The rest of the word, "sens", is in blue. The logo is simple and modern.

i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea Tel: +82-2-916-6191 Fax: +82-2-942-2514

GLUCOCARD Shine Connex BGMS: Intended Use:

GLUCOCARD Shine Express BGMS:

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i·sens

i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea

Comparison to the Predicate Device
Characteristic	Predicate Device (K170614)CareSens N Premier BGMSCareSens N Premier BT BGMS	Candidate DeviceGLUCOCARD Shine Connex BGMSGLUCOCARD Shine Express BGMS
Intended Use	The CareSens N Premier Blood Glucose Monitoring Systemis intended for the quantitative measurement of glucose infresh capillary whole blood samples drawn from thefingertips. The CareSens N Premier Blood GlucoseMonitoring System is intended for self-testing outside thebody (in vitro diagnostic use) by people with diabetes athome as an aid to monitor the effectiveness of diabetescontrol. The system is intended to be used by a single personand should not be shared. It is not intended for use onneonates and is not for the diagnosis or screening of diabetes.The CareSens N Single Blood Glucose Test Strips are for usewith the CareSens N Premier Blood Glucose Meter toquantitatively measure glucose in fresh capillary wholeblood samples drawn from the fingertip.	Same
Common name	System, test, blood glucose, over the counter	Same
Test Principle	Electro-chemical reaction. The glucose meter measureselectrical current generated by enzyme using the glucose assubstrate in sample.	Same
Enzyme	Glucose Oxidase- Glucose Oxidase (Aspergillus sp.): 2.7 units- Hexaamineruthenium(III) chloride: 45.7 µg- Other ingredients: 1.6 ug	Same
Measurement Principle	Amperometric method	Same
Sample type	Fresh capillary whole blood	Same
Calibration	Plasma-equivalent	Same
Coding system	No coding required (Automatic code identification)	Same
Test time (sec.)	5	Same
Sample volume (ul)	0.5	Same
Measurement unit	mg/dL	Same
Test range (mg/dL)	20-600	Same
Operating Humidity	10~90%	Same
Power Source	Two 3.0V lithium batteries (CR2032)	Same
Memory capacity	Up to 1,000 test results	Same
Test result average range	1, 7,14, 30 and 90 days(Pre-meal, Post-meal, Fasting and Total)	Same
Operating Temperature	42.8-111.2°F	Same
Hematocrit range (%)	15~65	Same

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i·sens

i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea

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i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea Tel: +82-2-916-6191 Fax: +82-2-942-2514

Performance Data

Non-clinical

Verification, validation and testing activities were conducted to establish the performance, functionality and relisites of the modified devices. The device passed all of the tests based on pre-determined Pass/Fail criteria.

Cleaning and Disinfection

The candidate devices are intended for single use. Disinfection studies were performed on the meter and lancing device by an outside commercial testing service to evaluate effectiveness of disinfectant, CLOROX GERMICIDAL Wipes (EPA Reg. No: 67619-12), in preventing the spread of blood-borne pathogens, using (HBV). The results demonstrated complete inactivation of live virus inoculated on the materials of the meter and lancing device. We have also demonstrated that 260 each of cleaning and disinfection cycles for meter with the same disinfectant designed to simulate 5 years (260 each of cleaning and disinfection cycles for neter and lancing device) of single patient device use has no effect on the performance or the external materials of the meter and lancing device.

Conclusion

Based on the submitted information in this premarket notification, the candidate devices are substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.