(77 days)
The GLUCOLAB™ Diabetes Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings., including physician's office laboratories and point of care sites . The GLUCOLAB™ System provides plasma equivalent results. The GLUCOLAB™ System is not intended to be used with neonatal blood samples. The GLUCOLAB™ System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the forearm, upper arm, palm, calf and thigh.
The GLUCOLAB™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood, which is used with the GLUCOLAB™ Test Strips. The test principle is: This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result.
Infopia, Co., Ltd. GLUCOLAB™ Blood Glucose Monitoring System Study Analysis
This analysis is based on the provided 510(k) summary for the Infopia, Co., Ltd. GLUCOLAB™ Blood Glucose Monitoring System.
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., accuracy percentages, error ranges). Instead, the document focuses on substantial equivalence to predicate devices. The implicit acceptance criterion is that the GLUCOLAB™ system performs comparably to the identified predicate devices: LifeScan, Inc., OneTouch® Ultra®, LifeScan, Inc. SURESTEP®, and Roche Diagnostics Corp. Accu-Chek Advantage.
The summary indicates that the GLUCOLAB™ Module is "substantially equivalent to the other products in commercial distribution intended for similar use." This is the reported device performance in relation to the acceptance criteria of substantial equivalence.
2. Sample Size and Data Provenance
The provided 510(k) summary does not contain information regarding:
- Sample size used for the test set.
- Data provenance (e.g., country of origin of the data, retrospective or prospective).
Without a detailed clinical study report, these crucial details cannot be extracted from the given text.
3. Number and Qualifications of Experts for Ground Truth
The provided 510(k) summary does not contain information regarding:
- Number of experts used to establish the ground truth for the test set.
- Qualifications of those experts.
For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods, not necessarily by human experts in the same way an imaging device might use radiologists. However, the document does not specify how the accuracy of the blood glucose readings was verified.
4. Adjudication Method
The provided 510(k) summary does not contain information regarding the adjudication method used for the test set. Given the nature of blood glucose testing, traditional adjudication methods like 2+1 or 3+1 concensus are unlikely to be directly applicable. Instead, the "ground truth" would be established by a gold standard laboratory method. However, the exact process is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used for diagnostic imaging devices where human readers interpret medical images. This device is an in vitro diagnostic (IVD) device for quantitative measurement of glucose, and its performance is assessed through its direct measurement accuracy, not through human interpretation of complex data. Therefore, the concept of "human readers improving with AI vs without AI assistance" is not relevant to this type of device.
6. Standalone Performance Study
Yes, a standalone (i.e., algorithm only without human-in-the-loop performance) study was effectively done. For an in vitro diagnostic device like a blood glucose meter, the "standalone" performance refers to the accuracy of the device itself in measuring glucose levels. The 510(k) summary states that "The GLUCOLAB™ Monitor is an in vitro diagnostic device designed for measuring the concentration of glucose in whole blood..." and that "The test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. This reaction is measured by the Meter and displayed as your blood glucose result." This describes the direct, standalone operation of the device to produce a measurement.
While the document doesn't explicitly detail the study methodology to prove this standalone performance (e.g., through clinical trials comparing device readings to a laboratory standard), the entire 510(k) submission process for a blood glucose meter inherently requires demonstrating accurate performance of the device itself. The claim of "substantial equivalence" is based on the device's ability to produce similar accurate readings to the predicate devices.
7. Type of Ground Truth Used
The specific type of ground truth used to establish the accuracy of the GLUCOLAB™ system is not explicitly stated in the provided 510(k) summary. However, for blood glucose monitoring systems, the ground truth is typically established using laboratory reference methods (e.g., hexokinase method, glucose oxidase method) performed on blood samples. These methods are considered the "gold standard" for blood glucose measurement.
8. Sample Size for the Training Set
The provided 510(k) summary does not contain information regarding the sample size for the training set. Blood glucose meters typically do not involve "training sets" in the same way machine learning AI models do. Their calibration and established performance are based on engineering design, chemical reactions, and manufacturing consistency, validated through clinical performance studies.
9. How Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" with associated ground truth is not typically applicable to a blood glucose meter in the context of an AI/machine learning model. The device operates based on a direct electrochemical principle. Therefore, there is no information provided on how ground truth for a training set was established because such a concept is not directly relevant to the described device and its underlying technology. The closest equivalent would be the manufacturing calibration process and subsequent validation against laboratory reference methods.
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Infopia, Co., Ltd.
510(k) for In Vitro Diagnostic Device
KOS/28)
510(k) SUMMARY (As required by 21.CFR.807.92) According to the requirements of 21 CFR.807.92, the following Introduction: information provides sufficient data to understand the basis for a determination of substantial equivalence. Infopia Co., Ltd. Submitted By: No. 1603, Dongil Technotown A bldg., 889-3 Kwanyang2-dong, Dongan-gu, Anyang Kyunggi, 431-716 Korea Phone: 82-31-423-6170 Fax: 82-31-423-6171 Byeong Woo, Bae Contact Person: Phone: 82-31-423-6170 Fax: 82-31-423-6171 Date Summary, Prepared: May 16, 2005 Propriety Name: GLUCOLABTM Device Name: Common Name: Blood Glucose Test System Classification Name: Class II, 862.1345 Glucose Blood Tester Predicate Device: We claim substantial equivalence to the LifeScan, Inc., OneTouch® Ultra®. Device GLUCOLAB™ Monitor is an in vitro diagnostic device Description: The designed for measuring the concentration of glucose in whole blood, which is used with the GLUCOLAB™ Test Strips. The test principle is: This device is an in vitro diagnostic product intended for the measurement of glucose concentration in human blood. The principle of the test relies upon a specific type of glucose in the blood sample, the dehydrogenase glucose that reacts to electrodes in the test strip. The test strip employs an electrochemical signal generating an electrical current that will stimulate a chemical reaction. This reaction is measured by the Meter and displayed as your blood glucose result. The GLUCOLABTM Diabetes Monitoring System is used for the Intended Use: quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. GLUCOLABTM System is for
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Infopia, Co., Ltd. 510(k) for In Vitro Diagnostic Device
510(k) Summary, Continued
| testing outside the body (in vitro diagnostic use only). Testingsites include the traditional fingertip testing along with alternatesite testing on the arm, palm, and thigh giving it an attractive,nearly painless alternative to the more painful fingertip site. . | |
|---|---|
| Comparison toPredicate Device: | The Infopia Co., Ltd. GLUCOLAB™ Module is substantiallyequivalent to the other products in commercial distributionintended for similar use. The most notable, it is substantiallyequivalent to the currently marketed item, the OneTouch® Ultra®by LifeScan, Inc. |
| Conclusion: | The GLUCOLAB™ Blood Glucose Monitoring System issubstantially equivalent to the following predicate devices:K024194 – LifeScan, Inc. OneTouch® Ultra®K984261 – LifeScan, Inc. SURESTEP®K021513 – Roche Diagnostics Corp. Accu-Chek Advantage |
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Image /page/2/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
AUG 2 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Infopia Co., Ltd. C/O Edward Letko American Healthcare, Inc. 304 Park Avenue South Suite 218 New York, NY 10010
$\pm$
Re: K051285
Trade/Device Name: Glucolab™ Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA, NBW, JJX Dated: May 16, 2005 Received: May 17, 2005
Dear Mr. Letko:
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).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benam
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Infopia, Co., Ltd. 510(k) for In Vitro Diagnostic Device
Indications for Use
K651285 510(k) Number:
Device Name: GLUCOLAB™
The GLUCOLAB™ Diabetes Monitoring System is used for the Indications For Use: Indications for ose. - The Occose level in whole blood as an aid in monitoring the quartitative "measurent in the home and in clinical settings., including physician's office laboratories and point of care sites . The GLUCOLAB™ System provides plasmaonlice laboratories and point of care System is not intended to be used with neonatal blood equivalent Tesalla. The OEM System is for testing outside the body (in vitro diagnostic use only). Samples. The GEOOOE.ID - Oyclorial is top tosting along with alternate site testing on the forearm, upper arm, palm, calf and thigh.
GlucoLab™ control is used with GlucoLab™ Brand System to check that the meter and test strips Oldcorab - online is a system and that you are performing the test correctly. It is very are working together as a system and that you are getting accurate results.
Control Solutions are sold separately
Prescription Use (Part 21 CFR 801 Subpart D)
Image /page/4/Picture/8 description: The image shows the text "AND/OR". The word "AND" is circled. The text is written in black ink on a white background.
Over-The-Counter Use X (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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vision/Sign-Off
ffice of In Vitro Diagnostic Device valuation and Safety
10(k) 051285
§ 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.