(247 days)
The DIAVUE Prudential Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. It is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples (from finger). This system is intended to be used by a single person and should not be shared. It should not be used for the diagnosis of or screening for diabetes, or testing on neonates.
The DIAVUE Blood Glucose Test Strips are to be used with the DIAVUE Prudential Blood Glucose Meter; it measures glucose in capillary whole blood taken from a fingertip. It is for use outside of body (in vitro diagnostic use). It is intended for lay use by people with diabetes and should only be used by a single patient. This system should not be shared. They are not indicated for the diagnosis or screening of diabetes or for neonatal use.
The DIAVUE Control Solutions are used with the DIAVUE Prudential Blood Glucose Meter and DIAVUE Blood Glucose Test Sreips to indicate appropriate user technique and to indicate that the test strip and meter are functioning properly.
The DIAVUE Prudential Blood Glucose Monitoring System consists of glucose meter, quick start user guide, user manual, warranty card, and carrying bag. Test strips, control solutions or sterile lancets can be purchased separately.
DIAVUE Control Solution contains a known amount of glucose that reacts with test strips made by BioCare. Three levels of control solutions are available : level 1.level 2 and level 3.Operation of the control solution test is similar to blood glucose test except that you use DIAVUE control solution instead of a drop of blood. The control solutions should provide results within an expected range printed on the test strip vial label.
This 510(k) summary does not contain the detailed study information needed to fully answer the request. The document focuses on demonstrating substantial equivalence to a predicate device for the purpose of regulatory clearance, rather than presenting a comprehensive clinical study report with acceptance criteria and performance data in the requested format.
Here's an analysis of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not include a table of acceptance criteria or detailed reported device performance in the typical format requested (e.g., accuracy against a reference method with specific percentages within certain glucose ranges). Instead, it states the device is "substantially equivalent" to a predicate device, which implies its performance is comparable and therefore acceptable.
Missing Information: Specific numerical acceptance criteria for accuracy, precision, or other performance metrics. Details of the device's actual performance against these criteria.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). Substantial equivalence claims often rely on bench testing and comparison to predicate device specifications, which may not involve large human subject studies detailed in this document.
Missing Information: Sample size for the test set, country of origin of data, and whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The 510(k) summary does not mention the use of experts to establish a ground truth for a test set. For glucose monitoring systems, ground truth is typically established by laboratory reference methods rather than expert consensus on interpretive tasks.
Missing Information: Number of experts, their qualifications.
4. Adjudication Method for the Test Set
Since expert consensus for ground truth is not mentioned, an adjudication method is also not applicable or not detailed in this summary.
Missing Information: Adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
MRMC studies are typically for devices where human interpretation of images or other data is central. For a blood glucose monitoring system, the "reader" is the device itself, and the "case" is the blood sample. This type of study is not applicable to a glucose meter in the way it would be for an imaging device. The document does not describe any study involving human readers improving with or without AI assistance.
Missing Information: MRMC study details, effect size.
6. Standalone Performance Study (Algorithm Only)
The DIAVUE Prudential Blood Glucose Monitoring System is an algorithm/device that performs measurement without human intervention in the measurement process itself (human-in-the-loop is for sample application and reading the result, not for interpreting raw data). Therefore, the "device performance" (alone) is what is being reviewed. However, the document does not present the detailed results of such a study, only the claim of substantial equivalence.
Information Present: The device is a standalone algorithm/device for measurement.
Missing Information: The results of a standalone performance study.
7. Type of Ground Truth Used
For a blood glucose monitoring system, the ground truth would typically be established by a laboratory reference method, such as a YSI glucose analyzer, which is considered highly accurate. The 510(k) summary does not explicitly state the type of ground truth used but it is implied to be a highly accurate chemical analysis method.
Missing Information: Explicit statement of the specific reference method used for ground truth.
8. Sample Size for the Training Set
The 510(k) summary does not mention any "training set." Glucose monitoring systems are typically calibrated during manufacturing and validated through performance testing, rather than "trained" in the manner of machine learning algorithms.
Missing Information: Sample size for the training set.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, this information is also not available in the document.
Missing Information: Method for establishing ground truth for the training set.
In conclusion: The provided 510(k) summary serves as a regulatory document for demonstrating substantial equivalence. It does not contain the detailed clinical study data, acceptance criteria, or methodological specifics that would be found in a full clinical trial report or a comprehensive validation study. The closest the document comes to "study information" is a list of similarities and differences with a predicate device, which is the basis for its claim of substantial equivalence.
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喬聯科技
www.biocare.com.tw
510(k) Summar
JULY 15 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
The Assigned 510(k) number is: K122307
1. Submitter's Name: BioCare Corporation
Address: 4F, No.12, Lane 5, Sec. 2, Nanshan Rd., Lujhu Township,
Taoyuan County 33852, Taiwan.
Contact person: Shuchi Chang / Administrator Phone: +886-3-2616678#6533
Fax: +886-3-2616679
E-mail:shuchichang@biocare.com.tw
2. Device Name and Classification
2.1 DIAVUE Prudential Blood Glucose Monitoring System
Trade name: DIAVUE Prudential Blood Glucose Monitoring System
Regulation section: 21 CFR 862.1345 Glucose Test System
Classification Code: CGA, Glucose Oxidase,
NBW, System, Test, Blood Glucose, Over The Counter
Classification Panel: Chemistry (75)
Device Classification: Class II
2.2 Control Solution
Trade name: DIAVUE Control Solution
Regulation section: 21 CFR 862.1660, Quality Control Material (Assayed and
Unassaved)
Classification Code: JJX-Single (Specified) Analyze Controls (Assayed and Unassayed)
Classification Panel: Clinical Chemistry (75)
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Image /page/1/Picture/0 description: The image shows a logo with Chinese characters and the website address "www.biocare.com.tw" underneath. The Chinese characters are written in a traditional style, and the logo has a simple design. The website address is written in a sans-serif font. The logo is likely for a company or organization based in Taiwan.
The Commitment to nignes vnige
BioCARE Corporation
Tot: +886 3 2616678 Fax:+88632616679
4F, No.12, Lane 5, Sec. 2, Nanshan Rd., Lujhu
Township, Taoyuan County 33852, TAIWAN
Device Classification: Class I
3. Predicate Device
3.1 Blood Glucose Monitoring System
The predicate device is URIGHT TD-4254 Blood Glucose Monitoring System (K082482) marketed by TaiDoc Technology Corporation.
3.2 Control Solution
The predicate device is TaiDoc Control Solution and FORA Control Solution (K093724) marketed by TaiDoc Technology Corporation.
4. Device Description
The DIAVUE Prudential Blood Glucose Monitoring System consists of glucose meter, quick start user guide, user manual, warranty card, and carrying bag. Test strips, control solutions or sterile lancets can be purchased separately.
DIAVUE Control Solution contains a known amount of glucose that reacts with test strips made by BioCare. Three levels of control solutions are available : level 1.level 2 and level 3.Operation of the control solution test is similar to blood glucose test except that you use DIAVUE control solution instead of a drop of blood. The control solutions should provide results within an expected range printed on the test strip vial label.
5. Intended Use
DIAVUE Prudential Blood Glucose Monitoring System :
The DIAVUE Prudential Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. It is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples (from finger). This system is intended to be used by a single person and should not be shared. It should not be used for the diagnosis of or screening for diabetes, or testing on newborns.
ર-2
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BIOCARE
The Commitment to Higher Value
BioCARE Corporation
Tel: +886 3 2616678 Fax: +886 3 2616679
4F, No.12, Lane 5, Sec. 2, Nanshan Rd., Lujhu
Township, Taoyuan County 33852, TAIWAN
DIAVUE Blood Glucose Test Strips:
The DIAVUE Blood Glucose Test Strips are to be used with the DIA VUE Prudential Blood Glucose Meter, it measures glucose in capillary whole blood taken from a fingertip. It is for use outside of body (in vitro diagnostic use). It is intended for lay use by people with diabetes and should only be used by a single patient. This system should not be shared. They are not indicated for the diagnosis or screening of diabetes or for neonatal use.
DIAVUE Control Solutions:
The DIAVUE Control Solutions are used with the DIAVUE Prudential Blood Glucose Monitoring Systems to indicate appropriate user technique and to indicate that the test strip and meter are functioning properly.
6. Comparison with predicate:
The DIAVUE Prudential Blood Glucose Monitoring System has the following similarities to the predicate device:
- Same operating principle, �
- � Same fundamental scientific technology,
- Incorporate the same material, �
- Same shelf life.
- Package using the same materials
The differences between the two devices list as: weight, dimensions, display, parameters and appearance. There are no significant differences that affect the safety and effectiveness. Therefore, BioCare DIAVUE Prudential Blood Glucose Monitoring System is substantially equivalent to the legally marketed device URIGHT TD-4254 Blood Glucose Monitoring System manufactured by TaiDoc Technology Corporation, K082482.
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| Image: [Logo of 僑聯聯科技 and www.biocare.com.tw] | Image: [BioCARE Logo and BioCARE Corporation contact information] | |
|---|---|---|
| DIAVUE Control Solution | Predicate Device:TaiDoc Control Solution andFORA Control Solution(K093724) | |
| Indications for Use | To indicate appropriate usertechnique and to indicate thatthe test strip and meter arefunctioning properly. | To check the performance ofblood glucose monitoringsystems manufactured byTaiDoc. |
| Analyte | d-glucose | Same |
| Matrix | Aqueous | Same |
| Number of Level(s) | 3 | 3 |
7. Test Principle:
The detection and measurement of glucose in blood is by an electrochemical biosensor technology using glucose oxidase.
8. Conclusions
Based on the information provided in this submission, the DIAVUE Prudential Blood Glucose Monitoring System is substantially equivalent to the predicate URIGHT TD-4254 Blood Glucose Monitoring System. The DIAVUE Control Solution is substantially equivalent to the predicate TaiDoc Control Solution and FORA Control Solution (K093724).
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2013
BioCare Corporation C/O Shuchi Chang 4F, NO. 12, LANE 5, SEC. 2 NASHAN RD LUJHU TOWNSHIP TAOYUAN COUNTY CHINA, (TAIWAN) 33852
Re: K122307
Trade/Device Name: DIAVUE Prudential Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: CGA, NBW, JJX Dated: February 25, 2013 Received: March 28, 2013
Dear Shuchi Chang:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carol G. Benson -S 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): K122307
DIAVUE Prudential Blood Glucose Monitoring System
The DIAVUE Prudential Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. It is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples (from finger). This system is intended to be used by a single person and should not be shared. It should not be used for the diagnosis of or screening for diabetes, or testing on neonates.
DIAVUE Blood Glucose Test Strips
The DIAVUE Blood Glucose Test Strips are to be used with the DIAVUE Prudential Blood Glucose Meter; it measures glucose in capillary whole blood taken from a fingertip. It is for use outside of body (in vitro diagnostic use). It is intended for lay use by people with diabetes and should only be used by a single patient. This system should not be shared. They are not indicated for the diagnosis or screening of diabetes or for neonatal use.
DIA VUE Control Solutions
The DIAVUE Control Solutions are used with the DIAVUE Prudential Blood Glucose Meter and DIAVUE Blood Glucose Test Sreips to indicate appropriate user technique and to indicate that the test strip and meter are functioning properly.
Prescription Use (Part 21 CFR 801 Subpart D)
AND / OR
Over-The-Counter Use মি (21 CFR 801 Subpart C)
(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Image /page/6/Picture/13 description: The image shows the name "Katherine Serrano" in a bold, sans-serif font. The name is written in black ink on a white background. The letters are evenly spaced and easy to read. The name appears to be a signature or a title.
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§ 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.