(92 days)
Not Found
No
The summary describes a standard blood glucose monitoring system that uses an electrical current to measure glucose. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on the electrical connector pattern, further indicating a non-AI/ML technology.
No
The device is a quantitative blood glucose monitoring system, used as an aid to monitor the effectiveness of diabetes control, not to actively treat the condition.
No
The text 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 not used for diagnosing a condition but rather for monitoring an already diagnosed condition (diabetes).
No
The device description explicitly lists hardware components such as the AUTO-CHEK Meter, Test Strips, Control Solutions, Lancing Device, and Lancets, indicating it is a hardware-based system with associated software, not a software-only device.
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 "self testing outside the body (in vitro) by people with diabetes at home". The term "in vitro" directly indicates that the testing is performed outside of a living organism.
- Measurement of Analytes: The system measures the quantitative level of glucose in blood samples. Measuring analytes in biological samples is a core function of IVD devices.
- Sample Type: It uses "fresh capillary whole blood samples", which are biological specimens.
- Purpose: The purpose is to "monitor the effectiveness of diabetes control", which is a diagnostic aid.
Therefore, based on the provided information, the AUTO-CHEK Blood Glucose Monitoring System clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AUTO-CHEK 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 AUTO-CHEK 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 AUTO-CHEK Blood Glucose Test Strips are for use with the AUTO-CHEK Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
The AUTO-CHEK Control Solutions are for use with the AUTO-CHEK Meter and AUTO-CHEK Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.
Product codes (comma separated list FDA assigned to the subject device)
CGA, NBW, JJX
Device Description
The AUTO-CHEK Blood Glucose Monitoring System (BGMS) measures the glucose level in whole blood samples using a small electrical current generated in the test strips. The system consists of the followings: the AUTO-CHEK Meter, AUTO-CHEK Test Strips, AUTO-CHEK Control Solutions with two different glucose concentrations ("Control A" and "Control B" ranges, sold separately), a Lancing Device, Lancets, a User's manual, and a Logbook.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
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 validations were conducted in order to verify that the modified electric connector pattern has not caused any adverse effects on the safety and effectiveness of the candidate device. The test results showed that the candidate device operated effectively, accurately, and safely.
Disinfection studies were performed on the AUTO-CHEK 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 260 each of pre-cleaning and disinfection cycles with the same disinfectant designed to simulate 5 years of use has not affected either the performance of the meter and the lancing device or the external materials of the meter and lancing device demonstrating the robustness of the meter and lancing 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
KI21654
Image /page/0/Picture/1 description: The image shows the logo for i-sens. The logo features a lowercase letter 'i' inside of a circle. To the right of the circle is the word 'sens' in lowercase letters. The font is bolded and black.
י א
465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea
Tel. 82-2-916-6191
510(k) Summary
SEP 5 2012
(As required by 21 CFR 807.92)
| Type of 510(k): | Special 510(k) |
|---|---|
| Submitted By: | i-SENS, Inc. |
| 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@i-sens.com | |
| Prepared Date: | May 25, 2012 |
| Device Name: | Trade name: AUTO-CHEK Blood Glucose Monitoring System |
| Common Name: Glucose Test System | |
| Regulatory Information: | 1) Regulation section: 21 CFR 862.1345 Glucose Test System, |
| 21 CFR 862.1660, Quality control material | |
| 2) Classification: Class II, Class I | |
| 3) Product Code: CGA - glucose oxidase, glucose | |
| NBW - system, test, blood glucose, over the counter | |
| JJX - Quality control material | |
| 4) Panel: Clinical Chemistry (75) |
.
1
Intended Use: The AUTO-CHEK 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 steadystate blood glucose conditions. The AUTO-CHEK 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 AUTO-CHEK Blood Glucose Test Strips are for use with the AUTO-CHEK Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites. The AUTO-CHEK Control Solutions are for use with the AUTO-CHEK Meter and AUTO-CHEK Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.
Device Description:
The AUTO-CHEK Blood Glucose Monitoring System (BGMS) measures the glucose level in whole blood samples using a small electrical current generated in the test strips. The system consists of the followings: the AUTO-CHEK Meter, AUTO-CHEK Test Strips, AUTO-CHEK Control Solutions with two different glucose concentrations ("Control A" and "Control B" ranges, sold separately), a Lancing Device, Lancets, a User's manual, and a Logbook.
l ) Predicate Device Name: COOL Blood Glucose Monitoring System
Substantial Equivalence Information:
-
Predicate 510(k) Number: K103396
-
Comparison with Predicate Device:
The modified AUTO-CHEK BGMS has the following features that are identical to the predicate device:
2
i-SENS, Inc. 465-6 Wolgye-dong, Nowon-gu, Seoul 139-845, Korea
Tel. 82-2-916-6191
- Intended use
- . Measurement principle
- I Fundamental scientific technology
- 1 Technical specifications
- Operating ranges
The modifications that was made on the AUTO-CHEK BGMS compared to COOL BGMS are:
- . The shape of meter's housing
- . The electric connector pattern of the test strip
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.
Technological The AUTO-CHEK BGMS has the same fundamental scientific technology as Characteristics: the predicate device.
Assessment of Performance Characteristics:
When compared with the predicate device, the basic features of the candidate device, the intended use, measurement principle, fundamental scientific technology, technical specifications, and operating ranges, are all the same, The only differences are the shape of meter's housing and electric connector pattern of the test strip. The validations were conducted in order to verify that the modified electric connector pattern has not caused any adverse effects on the safety and effectiveness of the candidate device. The test results showed that the candidate device operated effectively, accurately, and safely.
Summary of Pre-cleaning and Disinfection:
Disinfection studies were performed on the AUTO-CHEK 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
3
(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 pre-cleaning and disinfection cycles with the same disinfectant designed to simulate 5 years of use has not affected either the performance of the meter and the lancing device or the external materials of the meter and lancing device demonstrating the robustness of the meter and lancing device.
Conclusion:
Based on the validation results, the candidate device, AUTO-CHEK BGMS, is substantially equivalent to the predicate device. Further, the AUTO-CHEK BGMS has met the performance, safety, and effectiveness of the device for its intended use.
7 - 4
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
10903 New Hampshire Avenue Silver Spring, MD 20993
I-SENS, Inc. c/o Hyun Joon Oh Division Manager, Quality Assurance 465-6 Wolgye-Dong, Nowon-GU SEOUL, Republic of Korea 139-845
SEP 5 2012
K121654 Re:
Trade Name: AUTO-CHEK Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: CGA, NBW, JJX Dated: August 1, 2012 Received: August 6, 2012
Dear Dr. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
Image /page/4/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms, representing care and protection.
5
Page 2 .
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your do need in our incomes on Safety at (301) 796-5450. Also,
contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (3 contact the Office of in Virto Diagnound Boding by reference to premarket notification" (21) please note the regarding postmarket surveillance, please contact CDRH's CFK Farl 607.97). Por questions regulains postmarket Surveillance at (301). Office of Survelliance and Drometre s (OB a) of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
CFK Fall 805), picaso go to map 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 You may outain other general mormation on your consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address (800) 036-2041 of (594-2041 of (50-10-2017) ou/Industry/default.htm
Sincerely yours,
N
Couriney 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
6
Indications for Use Form
510(k) Number (if known): K121654
Device Name: AUTO-CHEK Blood Glucose Monitoring System.
Indications for Use:
The AUTO-CHEK 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 AUTO-CHEK 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 AUTO-CHEK Blood Glucose Test Strips are for use with the AUTO-CHEK Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
The AUTO-CHEK Control Solutions are for use with the AUTO-CHEK Meter and AUTO-CHEK Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ ਮ
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Kathleen Lewis
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121654
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