(171 days)
CareSens N Premier Blood Glucose Monitoring System/CareSens N Premier BT Blood Glucose Monitoring System, K170614
No
The document describes a standard blood glucose monitoring system with added features like Bluetooth and talking capabilities. There is no mention of AI or ML in the intended use, device description, or performance studies. The technology described is based on the same platform as the predicate device, which is a traditional blood glucose meter.
No
This device is for monitoring glucose levels, not for treating or curing a condition. It is an in vitro diagnostic device used to aid in monitoring the effectiveness of diabetes control.
No
The text explicitly states: "It is not for the diagnosis or screening of diabetes."
No
The device description explicitly states that the system consists of a "hand held GLUCOCARD Shine Connex Blood Glucose Meter" or "hand held GLUCOCARD Shine Express Blood Glucose Meter," which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use section explicitly states: "The GLUCOCARD Shine Express Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use)..." and "The GLUCOCARD Shine Connex Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use)...".
This clearly indicates that the device is intended for use on samples taken from the human body (blood) to provide information about a person's health status (glucose levels), and the testing is performed outside of the body. This aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
NBW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip (for blood sample collection)
Indicated Patient Age Range
The device is "not intended for use on neonates".
Intended User / Care Setting
People with diabetes at home (self-testing outside the body / in vitro diagnostic use).
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CareSens N Premier Blood Glucose Monitoring System/CareSens N Premier BT Blood Glucose Monitoring System, K170614
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
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
1
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
2
Indications for Use
510(k) Number (if known) K181273
Device Name
GLUCOCARD Shine Express Blood Glucose Monitoring System
Indications for Use (Describe)
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.
| 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."
3
Indications for Use
510(k) Number (if known) K181273
Device Name
GLUCOCARD Shine Connex Blood Glucose Monitoring System
Indications for Use (Describe)
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.
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."
4
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 accordance
with 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, Korea
Tel.) +82-2-910-0453
Fax) +82-2-942-2514
e-mail: jhjung@i-sens.com
Contact Person: Joon Ho Jung |
| Prepared Date: | April 25th, 2017 |
| Device Name | GLUCOCARD Shine Connex Blood Glucose Monitoring System
GLUCOCARD 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).
5
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
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.
GLUCOCARD Shine Connex BGMS: Intended Use:
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.
GLUCOCARD Shine Express BGMS:
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.
6
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 BGMS | |||
| CareSens N Premier BT BGMS | Candidate Device | ||
| GLUCOCARD Shine Connex BGMS | |||
| GLUCOCARD Shine Express BGMS | |||
| Intended Use | The CareSens N Premier Blood Glucose Monitoring System | ||
| is intended for the quantitative measurement of glucose in | |||
| fresh capillary whole blood samples drawn from the | |||
| fingertips. The CareSens N Premier 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 CareSens N Single Blood Glucose Test Strips are for use | |||
| with the CareSens N Premier Blood Glucose Meter to | |||
| quantitatively measure glucose in fresh capillary whole | |||
| blood samples drawn from the fingertip. | Same | ||
| Common name | System, test, blood glucose, over the counter | Same | |
| Test Principle | Electro-chemical reaction. The glucose meter measures | ||
| electrical current generated by enzyme using the glucose as | |||
| substrate 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 | 1090% | Same | |65 | 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
7
i·sens
i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu 06646 Seoul, Korea
8
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.