(106 days)
The FORA G30 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 FORA G30 Blood glucose monitoring system can be used only during steady-state blood glucose conditions.
FORA G30 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 documentation is a 510(k) summary for the FORA G30 Blood Glucose Monitoring System. It describes the device, its intended use, and states that performance studies were conducted. However, it does not provide specific acceptance criteria or detailed results of those studies. The document confirms that the device was found to have "satisfactory performance" and be "suitable for its intended use" based on laboratory and clinical settings studies, but it lacks the quantitative data to fill out your requested table and answer many specific questions.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document | "demonstrates satisfactory performance" and "meets its intended use." Specific quantitative performance metrics (e.g., accuracy percentages, bias, precision) are not provided. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample size for test set: Not specified.
- Data provenance: "studied in the laboratory and in clinical settings". The country of origin is not explicitly stated for the studies themselves, but the submitter is from Taiwan. It's not specified if the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not specified.
- Qualifications of experts: Not specified. The studies involved "healthcare professionals and lay users," but the role of experts in establishing ground truth is not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication method: Not specified.
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:
- MRMC comparative effectiveness study: Not applicable. This device is a blood glucose monitoring system, not an AI-assisted diagnostic imaging device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone performance: The device itself is standalone in the sense that it provides a direct measurement. The performance studies would inherently assess the algorithm (meter and test strips) without human intervention in the result generation process. However, the document doesn't explicitly refer to "standalone performance" in the context of an algorithm separate from the device's main function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of ground truth: Not explicitly stated. For a blood glucose monitoring system, the ground truth would typically be established by a reference laboratory method (e.g., YSI analyzer) for comparison, but this is not specified in the provided text.
8. The sample size for the training set:
- Sample size for training set: Not specified. The document mentions "performance studies" but does not differentiate between training and test sets or their sizes.
9. How the ground truth for the training set was established:
- How ground truth for training set was established: Not specified.
{0}------------------------------------------------
MAY 12 2009
510 (k) Summary
Page 1-of-2
- Submitter Information Company name Contact person Address
TaiDoc Technology Corporation Yuhua Chen 6F, No. 127, Wugong 2nd Rd, Wugu Township, Taipei County, 24888, Taiwan (886-2) 6625-8188 (886-2) 6625-0288 yuhua.chen@taidoc.com Jan 23rd, 2009
- Name of Device Trade Names
Phone
Date Prepared
FAX
Common Names/Descriptions
Classification Names
FORA G30 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-4230 blood glucose monitoring system Blood Glucose Meter Blood Glucose Test Strips TaiDoc Technology Corporation K070472
{1}------------------------------------------------
4. Device Description
FORA G30 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
FORA G30 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
FORA G30 Blood Glucose Monitoring System has equivalent technological characteristics as the Clever Chek TD-4230 blood glucose monitoring system (K070472). FORA G30 Blood Glucose Monitoring System also has the same intended use as the Clever Chek TD-4230 blood glucose monitoring system
7. Performance Studies
The performance of FORA G30 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
FORA G30 Blood Glucose Monitoring System demonstrates satisfactory performance and is suitable for its intended use.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is rendered in black and white.
Public Health Service
MAY 12 2009
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
TaiDoc Technology Corporation c/o Yuhua Chen 6F, No. 127, Wugong 2nd Road Wugu Township, Taipei County China (Taiwan) 248
Re: K090187
Trade Name: FORA G30 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: NBW, CGA Dated: April 22, 2009 Received: April 24, 2009
Dear Yuhua Chen:
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).
{3}------------------------------------------------
Page - 2
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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/,
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 http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
$\mathcal{A}$ C.H.
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number: K090187
Device Name: FORA G30 Blood glucose monitoring system
Indications for Use:
The FORA G30 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 FORA G30 Blood glucose monitoring system can be used only during steady-state blood glucose conditions.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
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)
Kellu Schla
Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K090187
Page 1 of
ii
§ 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.