(693 days)
Not Found
No
The description focuses on standard blood glucose measurement technology and does not mention any AI or ML components or capabilities.
No
This device is an in vitro diagnostic (IVD) device intended for measuring glucose levels, not for treating a condition. Its purpose is to monitor the effectiveness of diabetes control, not to provide therapy itself.
Yes
The device is explicitly stated to be for "in vitro diagnostic use" and is intended to quantitatively measure glucose, which is a diagnostic purpose to monitor diabetes control.
No
The device description explicitly lists hardware components: a meter, test strips, and control solutions. It is a system that includes physical components for measuring blood glucose.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use statement explicitly states: "It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control."
This clearly indicates that the device is designed to be used outside the body to test a biological sample (blood) for diagnostic purposes (monitoring glucose levels).
N/A
Intended Use / Indications for Use
The Bioland G-425-2V Blood Glucose Monitoring System is comprised of Bioland G-425-2V blood glucose meter and Bioland Blood Glucose Test Strips.
The Bioland G-425-2V Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The Bioland Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Bioland G-425-2V Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The Bioland G-425-2V Blood Glucose Monitoring System is not for use in neonates.
The Bioland G-425-2 Blood Glucose Monitoring System is comprised of Bioland G-425-2 blood glucose meter and Bioland Blood Glucose Test Strips.
The Bioland G-425-2 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The Bioland Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Bioland G-425-2 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The Bioland G-425-2 Blood Glucose Monitoring System is not for use in neonates.
Product codes (comma separated list FDA assigned to the subject device)
NBW
Device Description
The Bioland G-425-2V Blood Glucose Monitoring System consists of three main components: the meter (with voice feature, no Bluetooth features), test strip and control solutions. Bioland Blood Glucose Test Strips (Test strips are the same as K191657) and Bioland Glucose Control Solution (Control solution are the same as K191657) can be used with the Bioand G-425-2V Blood Glucose Monitoring System.
The Bioland G-425-2 Blood Glucose Monitoring System consists of three main components: the meter (No voice feature, no Bluetooth features), test strip and control solutions. Bioland Blood Glucose Test Strips (Test strips are the same as K191657) and Bioland Control Solution (Control solution are the same as K191657) can be used with the Bioland G-425-2 Blood Glucose Monitoring System.
The Bioland G-425-2V / G-425-2 Blood Glucose Monitoring System consists of:
- a) Bioland G-425-2V / G-425-2 Blood Glucose Meter;
- Bioland Blood Glucose Test Strips; b)
- C) Bioland Glucose Control Solution;
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip
Indicated Patient Age Range
Not for use in neonates.
Intended User / Care Setting
Used by a single person for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The risk analysis was conducted according to ISO 14971: 2019 Standard. A Failure Modes and Effects Analysis (FMEA) were assessed to identify potential hazard and unaccepted risks for each modification, The control measures were to mitigate these risks to acceptable level with the implemented verification and validation activities. The complete analysis was in risk management report in this submission.
The verification and validation (V&V) activities were conducted based on the impact of the modification and detailed in the risk management report. All test results met acceptance criteria and are included in the software validation report.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 12, 2022
Bioland Technology Ltd. Eric Tan Regulatory manager No. A6B7 (Block G). ShangRong Industrial Zone, No. 5 Baolong Longgang District Shenzhen, Guangdong 518116 China
Re: K202739
Trade/Device Name: Bioland G-425-2V Blood Glucose Monitoring System Bioland G-425-2 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: May 16, 2022 Received: May 16, 2022
Dear Eric Tan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202739
Device Name
Bioland G-425-2V Blood Glucose Monitoring System
Indications for Use (Describe)
The Bioland G-425-2V Blood Glucose Monitoring System is comprised of Bioland G-425-2V blood glucose meter and Bioland Blood Glucose Test Strips.
The Bioland G-425-2V Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The Bioland Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Bioland G-425-2V Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The Bioland G-425-2V Blood Glucose Monitoring System is not for use in neonates.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K202739
Device Name
Bioland G-425-2 Blood Glucose Monitoring System
Indications for Use (Describe)
The Bioland G-425-2 Blood Glucose Monitoring System is comprised of Bioland G-425-2 blood glucose meter and Bioland Blood Glucose Test Strips.
The Bioland G-425-2 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The Bioland Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Bioland G-425-2 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The Bioland G-425-2 Blood Glucose Monitoring System is not for use in neonates.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary K202739
1. Applicant
Name: Bioland Technology Ltd.
Address: No. A6B7 (Block G) Shangrong Industrial.Zone, No.5 Baolong Road, Baolong Community Longgang District, 518116 Shenzhen, Guangdong PEOPLE'S REPUBLIC OF CHINA
Tel: +86 755 3690 0999
Fax: +86 755 3329 6299
Contact person: Eric Tan
E-mail: regulator-b@bioland.com.cn
The date of summary was prepared: 2021.12.30
2. Subject device
Trade name: Bioland G-425-2V Blood Glucose Monitoring System Bioland G-425-2 Blood Glucose Monitoring System Classification name: System, Test, Blood Glucose, Over the Counter Regulation Medical Specialty: Clinical Chemistry Product Code: NBW Regulation number: 862.1345 Device class: II Code of Federal Requlations: 21CFR 862.1345
3. Predicate Device
Device name: Bioland Blood Glucose Monitoring System K number: K191657 Manufacturer: Bioland Technology Ltd.
ব Indication for use
4.1 Bioland G-425-2V Blood Glucose Monitoring System
The Bioland G-425-2V Blood Glucose Monitoring System is comprised of Bioland G-425-2V Blood Glucose Meter and Bioland Blood Glucose Test Strips.
The Bioland G-425-2V Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The Bioland G-425-2V Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes
5
control. The Bioland G-425-2V Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The Bioland G-425-2V Blood Glucose Monitoring System is not for use in neonates.
4.2 Bioland G-425-2 Blood Glucose Monitoring System
The Bioland G-425-2 Blood Glucose Monitoring System is comprised of Bioland G-425-2 Blood Glucose Meter and Bioland Blood Glucose Test Strips.
The Bioland G-425-2 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The Bioland G-425-2 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Bioland G-425-2 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The Bioland G-425-2 Blood Glucose Monitoring System is not for use in neonates.
5. Device Description
The Bioland G-425-2V Blood Glucose Monitoring System consists of three main components: the meter (with voice feature , no Bluetooth features), test strip and control solutions. Bioland Blood Glucose Test Strips (Test strips are the same as K191657) and Bioland Glucose Control Solution (Control solution are the same as K191657) can be used with the Bioand G-425-2V Blood Glucose Monitoring System.
The Bioland G-425-2 Blood Glucose Monitoring System consists of three main components: the meter (No voice feature, no Bluetooth features), test strip and control solutions. Bioland Blood Glucose Test Strips (Test strips are the same as K191657) and Bioland Control Solution (Control solution are the same as K191657) can be used with the Bioland G-425-2 Blood Glucose Monitoring System.
The Bioland G-425-2V / G-425-2 Blood Glucose Monitoring System consists of:
- a) Bioland G-425-2V / G-425-2 Blood Glucose Meter;
- Bioland Blood Glucose Test Strips; b)
- C) Bioland Glucose Control Solution;
6. Principle of Operation
The Bioland G-425-2V Blood Glucose Monitoring System and Bioland G-425-2 Blood Glucose Monitoring System quantitatively measures the amount of glucose in whole blood from the
6
fingertip using amperometric technology. The test is based on the measurement of electrical current generated by the reaction of capillary whole blood glucose oxidase and a mediator on the test strip. The detected current signal is the glucose concentration in the sample, which is then calculated and displayed on the meter.
7. Substantial Equivalence table
7.1 Bioland G-425-2V Blood Glucose Monitoring System
Similarities
| Item | Predicate Device | Subject Device |
|---|---|---|
| Bioland Glucose Monitoring System | Bioland G-425-2V Glucose Monitoring | |
| System | ||
| Intended Use | Quantitative measurement of glucose in capillary whole blood from the fingertip. It is | |
| intended for use by people with diabetes mellitus at home (over-the-counter) as an aid | ||
| in monitoring the effectiveness of diabetes control program | ||
| Enzyme | Glucose oxidase | |
| Test Principle | Amperometric glucose biosensor | |
| Specimen Type | Capillary whole blood from fingertip | |
| Detecting Range | 40~600 mg/dL | |
| Measurement Unit | mg/dL | |
| Hematocrit Range | 20%~60% | |
| Sample Volume | ≥0.7uL | |
| Test strip calibration | No code function, no need to calibrate the meter | |
| Operating Range | 50 | |
| Measuring Time | 6s | |
| Memory | 448 Memories with date/time | |
| Power | "AAA" *2 Batteries | |
| Meter Size | 90mm54mm13mm | |
| Weight | 48.0g (Excluding batteries) |
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| External view | |
|---|---|
| Measurement mode | Test mode and control solution mode |
Differences
| Item | Predicate Device | Subject Device |
|---|---|---|
| Bioland Glucose Monitoring System | Bioland G-425-2V Glucose Monitoring System | |
| Bluetooth | Yes | No |
| Voice | No | Yes |
| Interface display | Image: Predicate Device Interface Display | Image: Subject Device Interface Display |
In comparison with the predicate device, the modifications of the subject device are as below:
-
- Trade name
Change the trade name from Bioland Blood Glucose Monitoring System to Bioland G-425-2V Blood Glucose Monitoring System in labeling;
- Trade name
-
- Bluetooth Function
Remove the Bluetooth function from the predicate device, both hardware and software have changed; The hardware changes are reflected in the removal of Bluetooth module and its supply circuit, but the product structure and the overall layout of PCB has not changed. The software changes remove the Bluetooth related software codes, and the glucose algorithm
- Bluetooth Function
8
and other software functions remain unchanged.
-
- Voice function
Add the voice function from the predicate device. For the G-425-2V blood glucose meter, it broadcasts measurement value after completing measurement. Both hardware and software have changed, the hardware changes increase the horn, voice IC and its supply circuit, but the product structure and the overall layout of PCB does not change. The software change added the software code related to voice function, but the glucose algorithm and other software functions did not change.
- Voice function
-
- Interface display
Delete the icon " ... ", add the icon " (1) " , it is a change in the software.
- Interface display
7.2 Bioland G-425-2 Blood Glucose Monitoring System
Similarities
| Item | Predicate Device
Bioland Glucose Monitoring System | Subject Device
Bioland G-425-2 Glucose Monitoring System |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Intended Use | Quantitative measurement of glucose in capillary whole blood from the fingertip. It is
intended for use by people with diabetes mellitus at home (over-the-counter) as an aid
in monitoring the effectiveness of diabetes control program | |
| Enzyme | Glucose oxidase | |
| Test Principle | Amperometric glucose biosensor | |
| Specimen Type | Capillary whole blood from fingertip | |
| Detecting Range | 40600 mg/dL | |40°C), 15~85%RH | |
| Measurement Unit | mg/dL | |
| Hematocrit Range | 20%60% | |104°F (10
| Sample Volume | ≥0.7uL | |
| Test strip calibration | No code function, no need to calibrate the meter | |
| Operating Range | 50
| Measuring Time | 6s | |
| Memory | 448 Memories with date/time | |
| Power | "AAA" 2 Batteries | |
| Meter Size | 90mm54mm*13mm | |
| Weight | 48.0g (Excluding batteries) | |
9
| External view | Image: bioland device |
|---|---|
| Measurement mode | Test mode and control solution mode |
Differences
| Item | Predicate Device | Subject Device |
|---|---|---|
| Bioland Glucose Monitoring System | Bioland G-425-2 Glucose Monitoring | |
| System | ||
| Bluetooth | Yes | No |
| Interface display | Image: Predicate Device Interface Display | Image: Subject Device Interface Display |
In comparison with the predicate device, the modifications of the proposed device are as below:
-
- Trade name
Change the trade name from Bioland Blood Glucose Monitoring System to Bioland G-425-2 Blood Glucose Monitoring System in labeling;
- Trade name
-
- Bluetooth Function
Remove the Bluetooth function from the predicate device, both hardware and software have changed; The hardware changes are reflected in the removal of Bluetooth module and its supply circuit, but the product structure and overall layout of PCB has not changed. The software changes remove the Bluetooth related software codes, and the glucose algorithm and other software functions remain unchanged.
- Bluetooth Function
-
- Interface display
10
Delete the icon " W , it is a change in the software.
8. Summary of Design Control Activities
Based on the modifications, the risk analysis was assessed, and the risks were identified and controlled with verifications and validation activities which mitigated the risk index to acceptability. The risk analysis and design control activities were summarized below:
8.1 Risk Analysis
The risk analysis was conducted according to ISO 14971: 2019 Standard. A Failure Modes and Effects Analysis (FMEA) were assessed to identify potential hazard and unaccepted risks for each modification, The control measures were to mitigate these risks to acceptable level with the implemented verification and validation activities. The complete analysis was in risk management report in this submission.
8.2 Verification and Validation activities
The verification and validation (V&V) activities were conducted based on the impact of the modification and detailed in the risk management report. All test results met acceptance criteria and are included in the software validation report.
9. Conclusion
The Bioland G-425-2V Blood Glucose Monitoring System and Bioland G-425-2 Blood Glucose Monitoring System are substantially equivalent to the predicate device (K191657), Bioland Blood Glucose Monitoring System.