(92 days)
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.
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.
Here's an analysis of the provided text regarding the AUTO-CHEK Blood Glucose Monitoring System, focusing on acceptance criteria and study details. It's important to note that the provided document is a 510(k) summary for a "Special 510(k)" and primarily focuses on demonstrating substantial equivalence to a predicate device after a modification. Therefore, it does not contain extensive details about new clinical studies that would typically describe the acceptance criteria and performance as if it were a de novo submission.
The document states: "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." This implies that the 'acceptance criteria' were likely tied to demonstrating that the modified device performed equivalently to the predicate device, which would have previously met certain accuracy standards.
The document also mentions "performance, safety, and effectiveness of the device for its intended use" as being met, but it doesn't quantify these.
Acceptance Criteria and Reported Device Performance
Given the nature of this document (a special 510(k) for minor modification), specific numerical acceptance criteria and a detailed performance table from new clinical studies are not explicitly provided.
However, for blood glucose monitoring systems, the generally accepted performance criteria (often referenced by organizations like ISO 15197) involve accuracy within certain bounds compared to a laboratory reference method. Since this document states "The test results showed that the candidate device operated effectively, accurately, and safely," and claims substantial equivalence to the predicate "COOL Blood Glucose Monitoring System," it implicitly means it met the accuracy standards expected of such devices.
Based on typical regulatory expectations for glucose meters, hypothetical (but not explicitly stated in the document) acceptance criteria and their implied fulfillment would be:
| Acceptance Criteria (Hypothetical, based on industry standards like ISO 15197) | Reported Device Performance (Implied from the document) |
|---|---|
| Accuracy: | |
| - For glucose concentrations < 75 mg/dL: ≥ 95% of results within ± 15 mg/dL of laboratory reference. | "operated effectively, accurately, and safely" (implied compliance with predicate's accuracy) |
| - For glucose concentrations ≥ 75 mg/dL: ≥ 95% of results within ± 20% of laboratory reference. | "operated effectively, accurately, and safely" (implied compliance with predicate's accuracy) |
| Precision: Low coefficient of variation (CV) for repeated measurements. | Implied as part of "operated effectively, accurately, and safely" and substantial equivalence. |
| Interfering Substances: No significant bias due to common interfering substances. | Implied as no adverse effects due to modification. |
| User Performance: Lay user studies demonstrating correct usage and accurate results. | Not explicitly mentioned in this summary, but would be part of overall system validation. |
| Robustness: Maintenance of performance after simulated use/disinfection. | Demonstrated for disinfection cycles: "260 each of pre-cleaning and disinfection cycles... has not affected either the performance of the meter and the lancing device or the external materials." |
Other Study Information:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document implies that "validations were conducted" to verify the modified electric connector pattern. However, it does not specify the sample size for any test set related to blood glucose measurement accuracy.
- It does mention a sample size for robustness testing: "260 each of pre-cleaning and disinfection cycles." The provenance for this disinfection study is an "outside commercial testing service." No country of origin is specified for this particular study, nor is it explicitly stated if it's retrospective or prospective, though disinfection studies are typically prospective.
- For the core glucose measurement accuracy, the document refers to substantial equivalence to the predicate, suggesting that new large-scale clinical accuracy studies were not the primary focus of this specific 510(k) submission due to the minor modification.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not specified. The document does not describe a process of expert review or consensus for establishing ground truth, as it's a device for quantitative chemical measurement, where ground truth is typically established by a laboratory reference instrument (e.g., a YSI analyzer for glucose).
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not specified. This type of adjudication is typically used in image-based diagnostic studies involving human interpretation. For a blood glucose meter, ground truth is established by a reference chemical analyzer.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a blood glucose monitoring system, not an AI-assisted diagnostic tool that involves human readers/interpreters. There are no "human readers" in the context of this device.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The AUTO-CHEK Blood Glucose Monitoring System is a standalone device when performing a measurement. The "algorithm" in this context is the meter's firmware that converts the electrical current from the test strip into a glucose concentration. The document implies this "algorithm only" performance was assessed as part of the "effectively, accurately, and safely" statement by comparing it to standard glucose measurement methods (presumably the predicate device or a lab reference, though not explicitly detailed for this submission).
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implied: For blood glucose meters, the ground truth is typically established using a laboratory reference method (e.g., YSI glucose analyzer, hexokinase method) on the same blood samples. The document refers to "measurement principle" and "fundamental scientific technology" being the same as the predicate, which would have been validated against such reference methods.
-
The sample size for the training set
- Not applicable / Not specified. Blood glucose meters typically do not have a "training set" in the machine learning sense. Their "training" involves calibration during manufacturing based on known glucose concentrations. If this refers to design validation data, it's not specified.
-
How the ground truth for the training set was established
- Not applicable / Not specified. As above, the concept of a "training set" with established ground truth in the AI/ML context doesn't apply directly to a electrochemical blood glucose meter. The calibration of the device is done against precisely known glucose concentrations.
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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) |
.
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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:
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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
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(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
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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.
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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
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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
Page 1 of
§ 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.