(160 days)
Not Found
No
The summary describes a standard electrochemical blood glucose monitoring system and does not mention any AI or ML components.
No
The device is a blood glucose monitoring system, which is used for measurement and monitoring, not for treating a disease or condition. It aids in monitoring diabetes control but does not provide therapy.
No.
The "Intended Use / Indications for Use" section explicitly states: "It is not intended for use on neonates and is not for the diagnosis or screening of diabetes." This indicates that the device is for monitoring glucose levels, not for diagnosing diabetes.
No
The device description explicitly states that the system consists of a blood glucose meter, test strips, and control solutions, which are all hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states:
- "The system is intended for self testing outside the body (in vitro) by people with diabetes at home..." (for the single-patient system)
- "The system is intended for use outside the body (in vitro) and is intended for multiple-patient use in professional healthcare settings..." (for the multi-patient system)
The term "in vitro" directly indicates that the device is intended for use on samples taken from the body, rather than on the body itself, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CareSens N LINK Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The CareSens N LINK Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) 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 LINK Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
The CareSens N LINK Multi Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The system is intended for use outside the body (in vitro) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with auto-disabling, single use lancing device. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The CareSens N Multi Blood Glucose Test Strips are for use with the CareSens N LINK Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA
Device Description
The CareSens N LINK Blood Glucose Monitoring System (BGMS) consists of a blood glucose meter, single use test strips, and control solutions with two different glucose concentrations ("Control A" and "Control B" ranges, sold separately).
The CareSens N LINK Multi BGMS consists of a blood glucose meter, multi use test strips and the control solutions("Control A" and "Control B" ranges).
The CareSens N LINK and CareSens N LINK Multi BGMS are based on an electrochemical biosensor technology (electrochemical). The Systems measure the glucose level in whole blood samples using a small electrical current generated in the test strips.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh, and calf.
Indicated Patient Age Range
It is not intended for use on neonates.
Intended User / Care Setting
self testing outside the body (in vitro) by people with diabetes at home
multiple-patient use in professional healthcare settings
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)
The candidate device was tested in accordance with ISO 15197:2003(E). Analytical performance testing included system accuracy, repeatability, and intermediate precision testing. A user performance evaluation assessed accuracy of results and usability of the device in the hands of intended users. The candidate device performed similarly to both the predicate device as well as to a laboratory reference method, the Yellow Springs Instrument (YSI). All testing demonstrated safety and effectiveness of the candidate device and substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image contains a logo with the text 'i-sens' in a stylized font. The 'i' in 'i-sens' is lowercase and has a circular dot above it. The word 'sens' is in lowercase and is connected to the 'i'. A circle surrounds the entire 'i-sens' text, enclosing the logo within a circular border.
27-36 Gwangun-ro, Nowon-gu, Seoul 139-845, Korea
Tel. 82-2-916-6191
510(k) Summary
(As required by 21 CFR 807.92)
| Introduction: | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Type of 510(k): | Traditional 510(k) |
| Submitter
Information: | i-SENS, Inc.
27-36 Gwangun-ro, Nowon-gu, Seoul 139-845, Korea
Tel.) +82-33-903-0767
Fax) +82-33-748-6191
e-mail: cylim@i-sens.com
Contact Person: Chae Yun Lim |
| Prepared Date: | March 13, 2013 |
| Device Name
and
Classification | Trade names: CareSens N LINK Blood Glucose Monitoring System
CareSens N LINK Multi Blood Glucose Monitoring System
Common name: Blood Glucose Test System
Classification product code: NBW, CGA
Regulation number: 21 CFR 862.1345 Glucose Test System
Classification panel: 75, Chemistry
Device class: Class II |
| Predicate Device | CareSens N Blood Glucose Monitoring System (K083468) |
| Device
Description | The CareSens N LINK Blood Glucose Monitoring System (BGMS) consists of a
blood glucose meter, single use test strips, and control solutions with two different
glucose concentrations ("Control A" and "Control B" ranges, sold separately).
The CareSens N LINK Multi BGMS consists of a blood glucose meter, multi use
test strips and the control solutions("Control A" and "Control B" ranges).
The CareSens N LINK and CareSens N LINK Multi BGMS are based on an
electrochemical biosensor technology (electrochemical). The Systems measure the
glucose level in whole blood samples using a small electrical current generated in
the test strips. |
| Intended Use: | CareSens N LINK Blood Glucose Monitoring System
The CareSens N LINK Blood Glucose Monitoring System is intended for the
quantitative measurement of glucose in fresh capillary whole blood samples drawn
from the fingertips and alternative sites such as the forearm, palm, thigh, and calf.
Alternative site testing should be used only during steady-state blood glucose
conditions. The CareSens N LINK Blood Glucose Monitoring System is intended
for self testing outside the body ( in vitro ) 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
LINK Blood Glucose Meter to quantitatively measure glucose in fresh capillary
whole blood samples drawn from the fingertips and alternative sites.
CareSens N LINK Multi Blood Glucose Monitoring System
The CareSens N LINK Multi Blood Glucose Monitoring System is intended for
the quantitative measurement of glucose in fresh capillary whole blood samples
drawn from the fingertips and alternative sites such as the forearm, palm, thigh,
and calf. Alternative site testing should be used only during steady-state blood
glucose conditions. The system is intended for use outside the body ( in vitro ) and
is intended for multiple-patient use in professional healthcare settings as an aid to
monitor the effectiveness of diabetes control. The system is only used with auto-
disabling, single use lancing device. It is not intended for use on neonates and is
not for the diagnosis or screening of diabetes.
The CareSens N Multi Blood Glucose Test Strips are for use with the CareSens N
LINK Multi Blood Glucose Meter to quantitatively measure glucose in fresh
capillary whole blood samples drawn from the fingertips and alternative sites. |
| Comparison to
the Predicate
Device | The candidate devices have the following features that are identical to the
predicate device:
Intended use Measurement principle Fundamental scientific technology Operating ranges |
| | The candidate devices are different from the predicate device for the following
aspects: |
| | The shape of meter's housing Test result average range Memory capacity Battery type Test strip ejector |
| | The candidate devices and predicate device use same control solutions. |
| Type of Test | Quantitative, Amperometric method, Glucose oxidase ( Aspergillus sp. ) |
| Test Principle | The reagent on the test strip produces a small electrical current using glucose as a
substrate in the blood sample. The meter converts electrical current to glucose
concentration. |
| Summary of
Pre-cleaning
and Disinfection | The device is intended for single patient home use and multiple patients use in a
professional healthcare setting. 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 hepatitis B
virus (HBV). The results demonstrated complete inactivation of live virus
inoculated on the materials of the meter and lancing device.
We have also demonstrated that 10,950 each of pre-cleaning and disinfection
cycles for meter with the same disinfectant designed to simulate 3 years of
multiple-patient use or 5 years (260 each of pre-cleaning and disinfection cycles
for meter and lancing device) of single patient device use has no effect on the
performance or the external materials of the meter and lancing device (for single
patient use only). |
| Data
demonstrating
substantial
equivalence | The candidate device was tested in accordance with ISO 15197:2003(E).
Analytical performance testing included system accuracy, repeatability, and
intermediate precision testing. A user performance evaluation assessed accuracy
of results and usability of the device in the hands of intended users. The candidate
device performed similarly to both the predicate device as well as to a laboratory
reference method, the Yellow Springs Instrument (YSI). All testing demonstrated
safety and effectiveness of the candidate device and substantial equivalence to the
predicate device. |
| | Although unlike the predicate device, the candidate device provides for the
wireless uploading of data from the monitor via Bluetooth transmission to a
Bluetooth paired digital devices such as the PC. However, the wireless transfer of
data has been validated and demonstrates a 100% correlation to actual monitor
data.
Therefore, there are no substantive differences between the products defined in
this 510(k) submission and the predicate device. |
| Conclusion | Based on the submitted information in this premarket notification, the
candidate devices are substantially equivalent to the predicate device.
Further, the candidate devices have met the performance, safety, and
effectiveness of the device for its intended use. |
1
Image /page/1/Picture/0 description: The image contains a logo with the text "i-sens" in a stylized font. The "i" is lowercase and enclosed in a circle. The word "sens" is also lowercase and connected to the "i". The logo appears to be for a company named i-sens.
.
,
2
3
Image /page/3/Picture/0 description: The image shows a logo with the word "i-sens" in a stylized font. The "i" is lowercase and has a circular design above it, resembling a stylized atom or a target. The rest of the word "sens" is in lowercase as well, with a slightly bolder font. The logo has a simple and modern design.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services-USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized eagle or bird in flight.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2013
i-SENS. Inc C/O Chae Yun Lim 27-36 Gwangun-ro, Nowon-gu, Seoul 139-845, Korea
Re: K130696
Trade/Device Name: CareSens N Link Blood Glucose Monitoring System CareSens N Link Multi Blood Glucose Monitoring System
Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: July 10, 2013 Received: July 11, 2013
Dear Chae Yun Lim:
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. Iisting 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 Part 801); 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.
5
Page 2-Chae Yun Lim
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/McdicalDevices/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Carol C. Benson -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
6
Indications for Use Form
510(k) Number (if known): K130696
Device Name: CareSens N LINK Blood Glucose Monitoring System
Indications for Use:
The CareSens N LINK Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The system is intended for self-testing outside the body (in vitro) 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 LINK Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use ਮ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Katherine Serrano -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) k1320696
Page 1 of 2
7
Indications for Use Form
510(k) Number (if known): K130696
Device Name: CareSens N LINK Multi Blood Glucose Monitoring System
Indications for Use:
The CareSens N LINK Multi Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The system is intended for use outside the body (in vitro) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control. The system is only used with auto-disabling, single use lancing device. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The CareSens N Multi Blood Glucose Test Strips are for use with the CareSens N LINK Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use X (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Katherine Serrano -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K130696
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