(120 days)
The Maximed Exichek TD 4224 Blood glucose monitoring system is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The alternative site testing in the Maximed Exichek TD 4224 Blood glucose monitoring system can be used only during steady-state blood glucose conditions.
Maximed Exichek TD 4224 blood glucose monitoring system consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.
The provided text describes the 510(k) summary for the Maximed Exichek TD 4224 Blood Glucose Monitoring System. However, it does not contain specific details regarding acceptance criteria, reported device performance metrics (e.g., accuracy, precision), sample sizes for test or training sets, ground truth establishment methods, or information about expert involvement found in more comprehensive study reports.
The provided document only generally states that "The studies demonstrated that the performance of this system meets its intended use." and "Maximed Exichek TD 4224 blood glucose monitoring system demonstrates satisfactory performance and is suitable for its intended use."
Therefore, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific numerical acceptance criteria or detailed performance metrics (e.g., bias, precision, accuracy percentages within specific ranges) are provided in the document. The document only makes a general statement about meeting intended use.
Therefore, this table cannot be generated from the given text.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: The studies were conducted "in the laboratory and in clinical settings by healthcare professionals and lay users." The country of origin for the data is implied to be Iran (where the submitter company Exir Pharmaceutical Company is located), but this is not explicitly stated as the origin of the study data. The studies are prospective as they were conducted as part of the device's validation for 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document.
4. Adjudication method for the test set:
This information is not provided in the document.
5. 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:
This is a blood glucose monitoring system, not an imaging or diagnostic device typically requiring reader studies for interpretation. An MRMC study is not applicable in this context, and no such study is mentioned or implied. The device measures glucose levels directly.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is a blood glucose monitoring system with a meter and test strips. Its primary function is the "algorithm only" measurement of glucose from a blood sample. The "human-in-the-loop" aspect is the user collecting the sample and operating the device, but the measurement itself is standalone. The performance studies evaluated the system's ability to quantitatively measure glucose.
7. The type of ground truth used:
For blood glucose monitoring systems, the "ground truth" or reference method is typically obtained using a highly accurate laboratory reference instrument (e.g., YSI glucose analyzer) or a similar established method. This document does not explicitly state the specific ground truth method used, but it would be a standardized laboratory measurement.
8. The sample size for the training set:
Blood glucose meters typically do not involve "training sets" in the same way machine learning algorithms do. The device's calibration and algorithm are developed based on extensive characterization using chemical and biological samples, but a distinct "training set" as described for AI models is not applicable or mentioned here.
9. How the ground truth for the training set was established:
As mentioned, a "training set" in the AI sense is not applicable. The device's underlying principles and calibration would be established through a rigorous process of chemical and biological experimentation, compared against highly accurate laboratory reference methods for glucose measurement.
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MAY 2 5 2007
510 (k) Summary
Page 1-of-2
- Submitter Information Company name Contact person Address
Phone FAX E-mail
Date Prepared
- Name of Device Trade Names
Common Names/Descriptions
Classification Names
Exir Pharmaceutical Company Pejman Hosseinpour No.15,Rahmati alley,Valiasr st., (North of Valiasr sq.), Tehran, Iran, 15949 0098 ( ) 2188918466-7 0098 ) 2188899358 ( Hoseinpour@exir.co.ir Hoseinpour@exirpharma.com Jan 18th , 2007
Maximed Exichek TD 4224 Blood glucose monitoring system Blood Glucose Meter Blood Glucose Test Strips Class II devices (21 CFR Section 862.1345, Glucose Test System)
- Predicate Device Trade/Proprietary Name:
Common/Usual Name:
Manufacturer 510 (k) Number
Clever Chek TD-4223 blood glucose monitoring system Blood Glucose Meter Blood Glucose Test Strips TaiDoc Technology Corporation K063212
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4. Device Description
Maximed Exichek TD 4224 blood glucose monitoring system consists of a meter and test strips. The system utilizes an electrochemical method-based meter and dry reagent biosensor (test strips) for blood glucose testing. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measurement of glucose in fresh whole blood and control solutions.
5. Intended Use
Maximed Exichek TD 4224 blood glucose monitoring system is indicated for the quantitative measurement of glucose in fresh capillary whole blood taken from the finger and the alternative sites for self testing by persons with diabetes in the home or by healthcare professionals in healthcare facilities. Testing is done outside the body (in vitro diagnostic use).
The alternative site testing (the plam, the forearm, the upper arm, the calf and the thigh) in this system can be used only during steady-state blood glucose conditions.
6. Comparison to Predicate Device
Maximed Exichek TD 4224 blood glucose monitoring system has equivalent technological characteristics as the Clever Chek TD-4223 blood glucose monitoring system (K063212). Maximed Exichek TD 4224 blood glucose monitoring system also has the same intended use as the lever Chek TD-4223 blood glucose monitoring system
7. Performance Studies
The performance of Maximed Exichek TD 4224 blood glucose monitoring system was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the performance of this system meets its intended use.
8. Conclusion
Maximed Exichek TD 4224 blood glucose monitoring system demonstrates satisfactory performance and is suitable for its intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Exir Pharmaceutical Company c/o Erica Li TaiDoc Technology Corporation 4F, No. 88, Sec. 1, Kwang-Fu Rd., San-Chung - Taipei County Taiwan 241
MAY 2 5 2007
K070239 Re: Trade/Device Name: Maximed Exichek TD-4224 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: May 14, 2007 Received: May 18, 2007
Dear Ms. Li:
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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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) remarket notification. The FDA finding of substantial equivalence of your device to a legally president 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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. 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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Indications for Use
510(k) Number:
Device Name: Maximed Exichek TD 4224 Blood glucose monitoring system
Indications for Use:
The Maximed Exichek TD 4224 Blood glucose monitoring system is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The alternative site testing in the Maximed Exichek TD 4224 Blood glucose monitoring system can be used only during steady-state blood glucose conditions.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (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)
ii
Carol C. Benson
Sign-Off
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ാ of In Vitro Diagnostic Device Firstion and Safety
§ 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.