(264 days)
DA01 Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood sample (from the finger and the palm). The alternate site testing can be only used during steady-state blood glucose monitoring. The DA01 Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates.
The DA01 Blood Glucose Test Strips are used with the DA01 Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the finger and the palm.
The DA06 Glucose Control Solutions are for use with the DA01 Blood Glucose Test Strips and the DA01 Glucose Meter as a quality control check that the meter and test strip are working together properly, and that the test is performing correctly.
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Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the DA01 Blood Glucose Monitoring System, as best as can be extracted from the given document:
This document is primarily a 510(k) clearance letter from the FDA, and as such, it does not contain detailed information about the acceptance criteria and study results. It confirms that the device has been cleared for marketing based on a determination of substantial equivalence to a predicate device.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's what can be extracted and inferred:
Acceptance Criteria and Device Performance Study for DA01 Blood Glucose Monitoring System
1. A table of acceptance criteria and the reported device performance
Unfortunately, the provided FDA 510(k) clearance letter does not contain the specific acceptance criteria or the reported device performance data from the studies submitted by Delbio Incorporation. These details would typically be found in the original 510(k) submission document itself, not in the clearance letter.
2. Sample sized used for the test set and the data provenance
- Test Set Sample Size: Not available in this document.
- Data Provenance: Not available in this document. (e.g., country of origin, retrospective/prospective)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not available in this document. For a blood glucose monitoring system, the "ground truth" is typically established by a highly accurate laboratory reference method, not by human expert interpretation in the same way it would be for imaging studies.
4. Adjudication method for the test set
Not applicable/available. As mentioned above, for a glucose meter, adjudication by experts is not the standard method for establishing ground truth.
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
Not applicable. This device is a blood glucose monitor, not an AI-assisted diagnostic imaging system that would involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the performance of the device itself (the meter and test strips) in measuring glucose levels. While the clearance implies such studies were done to demonstrate accuracy against a reference method, the details of those standalone performance tests are not provided in this document. The device operates as a standalone measurement tool.
7. The type of ground truth used
For a blood glucose monitoring system, the ground truth would typically be established by a a highly accurate laboratory reference method for glucose measurement (e.g., a YSI analyzer or similar). This document does not explicitly state the reference method used.
8. The sample size for the training set
Not applicable/available. For a hardware device like a blood glucose meter, the concept of a "training set" as understood in machine learning is not directly relevant. Performance is demonstrated through analytical and clinical studies on its accuracy and precision.
9. How the ground truth for the training set was established
Not applicable. See point 8.
Summary of what can be gleaned from the document:
- Device Name: DA01 Blood Glucose Monitoring System
- Intended Use: Quantitative measurement of glucose level in fresh capillary whole blood samples (finger and palm) for in vitro diagnostic use, at home, by a single person.
- Purpose: As an aid in monitoring the effectiveness of diabetes control programs.
- Limitations: Not for diagnosis or screening of diabetes, nor for testing neonates. Alternate site testing only during steady-state blood glucose monitoring.
- Regulatory Class: Class II
- What this document does convey: The FDA found the device substantially equivalent to a predicate device, allowing it to be marketed. This determination implies that Delbio Incorporation submitted data (including performance studies) that met FDA requirements for substantial equivalence, but the details of those studies are not in this letter.
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Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold font. The text is centered in the image. The image is a close-up of the text.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 11, 2012
Delbio Incorporation c/o Nicky Pan 3F, No. 252, Shangying Road Guishan Industrial Zone Taoyuan County China (Taiwan) 33341
Re: K120866
Trade/Device Name: DA01 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: October 3, 2012 Received: October 25, 2012
Dear Nicky Pan:
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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Nicky Pan
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C: Benson for
Courtney H. Lias, Ph.D. Director
Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K120866
Device Name: DA01 Blood Glucose Monitoring System
Indications for Use:
DA01 Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood sample (from the finger and the palm). The alternate site testing can be only used during steady-state blood glucose monitoring. The DA01 Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In addition, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis or screening of diabetes, nor for the testing of neonates.
The DA01 Blood Glucose Test Strips are used with the DA01 Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the finger and the palm.
The DA06 Glucose Control Solutions are for use with the DA01 Blood Glucose Test Strips and the DA01 Glucose Meter as a quality control check that the meter and test strip are working together properly, and that the test is performing correctly.
Prescription Use (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Rattun Summs
Division Sign-Of Office of In Vitro Diagnostics and Radiological Health
510(k) K120866
§ 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.