(87 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the device and its operation does not mention any AI/ML components.
No
This device is a diagnostic tool used to measure blood glucose levels, aiding in the monitoring of a diabetes control program. It does not provide any therapeutic intervention or treatment.
No
The device is explicitly stated as "not for the diagnosis or screening of diabetes," but rather "as an aid in monitoring the effectiveness of a diabetes control program."
No
The device description explicitly lists hardware components such as a measuring meter, test strips, control solutions, lancing device, and lancets, indicating it is a hardware-based system with potentially embedded software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is intended for "in vitro (outside the body) testing at home by people with diabetes".
- Device Description: The description details how the system measures glucose in a "whole blood sample", which is a biological specimen tested outside the body.
- Definition of IVD: An In Vitro Diagnostic device is defined as a medical device intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, in order to provide information for diagnostic, monitoring or compatibility purposes. This device clearly fits this definition.
N/A
Intended Use / Indications for Use
The CareSens N POP Blood Glucose Monitoring System consists of a measuring meter, test strips and control solutions. The CareSens N POP Blood Glucose Meter is intended for use with the CareSens N Single Blood Glucose Test Strips for the quantitative measurement of glucose in capillary whole blood from the fingertip 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 Control Solutions are for use with the CareSens N POP Meter and CareSens N Single Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.
The CareSens N POP Blood Glucose Monitoring System is intended for self testing, in vitro (outside the body) testing at home by people with diabetes as an aid in monitoring the effectiveness of a diabetes control program. 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.
Product codes
CGA, NBW, JJX
Device Description
The CareSens N POP Blood Glucose Monitoring System (BGMS) measures the glucose level in whole blood sample by the meter using a small electrical current generated in the test strips. The system consists of the following: the CareSens N POP Meter, CareSens N Single Test Strips, CareSens Control Solutions with two different glucose concentrations ("Control A" and "Control B" ranges, sold separately), Lancing Device, Lancets, User's manual, Quick reference guide and Logbook.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip, forearm, palm, thigh and calf
Indicated Patient Age Range
Not intended for use on neonates
Intended User / Care Setting
self testing, in vitro (outside the body) testing at home by people with diabetes
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)
Disinfection studies were performed on the CareSens N POP meter and lancing device by an outside commercial testing service to determine the robustness of the meter and lancing device to the recommended pre-cleaning and disinfection protocol, and its effectiveness in preventing the spread of blood-borne pathogens, using hepatitis B virus (HBV). CLOROX GERMICIDAL Wipes (EPA Reg. No: 67619-12) was validated for complete inactivation of live virus inoculated on the materials of the meter and lancing device. We have also demonstrated that 260 each of pre-cleaning and disinfection cycles designed to simulate 5 years of use has affected neither the performance nor on the external materials for the meter and lancing device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/1 description: The image shows a logo with the text "I-sens" in a stylized font. The "I" is bold and slightly larger than the rest of the text. The logo is partially encircled by a circular graphic element, which appears to be a stylized representation of a globe or a similar round object. The overall design is simple and modern.
i-SENS, Inc. 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea
Tel. 82-2-916-6191
3 2012
510(k) Summary
(As required by 21 CFR 807.92)
Type of 510(k):
Special 510(k)
i-SENS, Inc.
Submitted By:
465-6, Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel.) +82-2-916-6191 Fax) +82-2-942-2514 www.i-sens.com .
Contact Person:
Dr. Hyun Joon Oh Tel.) +82-33-903-0760 Fax) +82-33-748-6191 e-mail: hjoh@j-sens.com
Prepared Date: .
February 1, 2012
Device Name:
Common Name:
Trade name: CareSens N POP Blood Glucose Monitoring System Glucose Test System
Regulatory Information: l ) Regulation section: 21 CFR 862.1345 Glucose Test System, 21 CFR 862.1660, Quality control material
- Classification:
Class II, Class I
- Product Code:
CGA - glucose oxidase, glucose NBW - system, test, blood glucose, over the counter JJX - Quality control material
- Panel:
Clinical Chemistry (75)
5 - 1
1
i-SENS, Inc. 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel. 82-2-916-6191
Intended Use:
The CareSens N POP Blood Glucose Monitoring System consists of a measuring meter, test strips and control solutions. The CareSens N POP Blood Glucose Meter is intended for use with the CareSens N Single Blood Glucose Test Strips for the quantitative measurement of glucose in capillary whole blood from the fingertip 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 Control Solutions are for use with the CareSens N POP Meter and CareSens N Single Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.
The CareSens N POP Blood Glucose Monitoring System is intended for self testing, in vitro (outside the body) testing at home by people with diabetes as an aid in monitoring the effectiveness of a diabetes control program. 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.
Device Description:
The CareSens N POP Blood Glucose Monitoring System (BGMS) measures the glucose level in whole blood sample by the meter using a small electrical current generated in the test strips. The system consists of the following: the CareSens N POP Meter, CareSens N Single Test Strips, CareSens Control Solutions with two different glucose concentrations ("Control A" and "Control B" ranges, sold separately), Lancing Device, Lancets, User's manual, Quick reference guide and Logbook.
Substantial Equivalence Information:
-
Predicate Device name: CareSens N Blood Glucose Monitoring System 2) Predicate 510(k) Number : K083468
-
Comparison with Predicate Device:
The modified CareSens N POP BGMS has the following features that are same to the predicate device:
- intended use
- I operating principle
5 - 2
2
Image /page/2/Picture/0 description: The image shows a logo with the text "I-sens" in a stylized font. The "I" is lowercase and has a circular design element to the left of it. The word "sens" is in a bolder, sans-serif font. The logo appears to be for a company or product named "I-sens."
i-SENS, Inc.
465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel. 82-2-916-6191
- fundamental scientific technology i
- I operating ranges
The test strips and the control solutions are the same as those of the predicate system, CareSens N Test Strips and CareSens Control Solutions.
The modifications from the predicate device are as follows:
- physical design
- 동 user interface
- software of meter 을
- software of displaying averages stored in the meter's memory
* Similarities and Differences between candidate and predicate device
| Features | CareSens N BGMS (K083468, Predicate Device) | CareSens, N.POP BGMS (Candidate Device) |
|---|---|---|
| Intended Use | It is intended to be used for quantitative measurement of glucose in fresh capillary whole blood as an aid to monitor the effectiveness of diabetes control in people with diabetes. | Same |
| Enzyme | Glucose Oxidase | Same |
| Measurement principle | Amperometric method | Same |
| Test principle | Electro-chemical reaction | Same |
| Sample | Capillary whole blood | Same |
| Test Time | 5 seconds | Same |
| Sample volume | Minimum 0.5 µL | Same |
| Test Range | 20 - 600 mg/dL | Same |
| Temperature | 50 - 104°F (10 - 40℃) | Same |
| Operating Humidity | 10 - 90% | Same |
| Hematocrit range | 20 - 60% | Same |
| Power | Two(2) 3.0 V lithium battery (CR2032) | Same |
3
Image /page/3/Picture/0 description: The image shows a logo with the text "i-sen" next to a graphic. The graphic is a circular design with a pattern of curved lines, resembling a stylized globe or network. The text "i-sen" is in a simple, sans-serif font, with the "i" in lowercase and the "sen" in lowercase as well.
Type of Test:
Tel. 82-2-916-6191 '
| Battery life | 1,000 tests | Same |
|---|---|---|
| Memory Capacity | 250 blood glucose values | 500 blood glucose values |
| Averaging | 14 days | 1, 7, 14, 30 and 90 days |
Quantitative, Amperometric method, Glucose oxidase (Aspergillus sp.)
The reagent on the test strip produces a small electrical current using glucose Test Principle: as a substrate in the blood sample. The Meter converts the electrical current to a concentration of glucose.
The CareSens N POP BGMS has the same fundamental scientific technology Technological Characteristics: as the predicate CareSens N BGMS.
Assessment of Performance Characteristics: When compared with CareSens N BGMS, the basic features of the CareSens N POP BGMS (including the intended use, operating principle, and fundamental scientific technology) are all the same except for the meter's appearance and output value. The CareSens N POP BGMS uses the same test strips (just a different name) and control solutions being used in the CareSens N POP BGMS. So, its performance, safety and effectiveness show results similar to the predicate device. Therefore, to check the features newly added to the CareSens N POP, validation testing was conducted and each feature was checked through the test results on whether or not they operated properly.
Summary of Pre-cleaning and Disinfection:
Disinfection studies were performed on the CareSens N POP meter and lancing device by an outside commercial testing service to determine the robustness of the meter and lancing device to the recommended pre-cleaning and disinfection protocol, and its effectiveness in preventing the spread of blood-borne pathogens, using hepatitis B virus (HBV). CLOROX GERMICIDAL Wipes (EPA Reg. No: 67619-12) was validated for complete inactivation of live virus inoculated on the materials of the meter and lancing device. We have also demonstrated that 260 each of pre-cleaning and disinfection cycles designed to simulate 5 years of use has affected neither
ર - 4
4
i-SENS, Inc.
Image /page/4/Picture/1 description: The image shows a logo with the text "I-sens" in bold, sans-serif font. To the left of the text is a circular graphic with three concentric rings, resembling an eye or a target. The logo has a slightly distressed or textured appearance, giving it a somewhat vintage or worn look.
465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea Tel. 82-2-916-6191
the performance nor on the external materials for the meter and lancing . deviçe.
Conclusion: ·
Based on the information provided in this submission, the CareSens N POP BGMS is substantially equivalent to the predicate CareSens N BGMS. The CareSens N POP BGMS has met the performance, safety, and effectiveness of the device for its intended use.
ર - ર
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird in flight.
10903 New Hampshire Avenue Silver Spring, MD 20993
I-Sens. Inc. c/o Hvun Joon Oh Division Manager, Quality Assurance 465-6 Wolgye-dong Nowon-gu Seoul, Republic of Korea 139-845
MAY - 3 2012
K120351 Re:
Trade/Device Name: CareSens N POP Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: April 2, 2012 Received: April 4, 2012
Dear Hyun Joon Oh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
6
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours,
C.
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use Form
510(k) Number (if known):
Device Name: _ CareSens N POP Blood Glucose Monitoring System
Indications for Use:
The CareSens N POP Blood Glucose Monitoring System consists of a measuring meter, test strips and control solutions. The CareSens N POP Blood Glucose Meter is intended for use with the CareSens N Single Blood Glucose Test Strips for the quantitative measurement of glucose in capillary whole blood from the fingertip 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 Control Solutions are for use with the CareSens N POP Meter and CareSens N Single Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.
The CareSens N POP Blood Glucose Monitoring System is intended for self testing, in vitro (outside the body) testing at home by people with diabetes as an aid in monitoring the effectiveness of a diabetes control program. 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.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
R. Chm
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K120351
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