(273 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing or training/test sets for algorithms. The performance studies focus on standard analytical and usability testing for a blood glucose meter.
No
Explanation: The device is an in vitro diagnostic device intended for the quantitative measurement of glucose, which is used to monitor the effectiveness of diabetes control. It does not treat or directly alleviate a medical condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The Bioland 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... as an aid to monitor the effectiveness of diabetes control." This quantitative measurement to monitor a health condition (diabetes) clearly indicates a diagnostic function, even though it's specified as "not for the diagnosis of or screening for diabetes" initially. The term "in vitro diagnostic use" further supports this.
No
The device description explicitly states that the system consists of a "Bioland Blood Glucose Meter" and "Bioland Blood Glucose Test Strips," which are hardware components. While it mentions data transfer via Bluetooth, the core functionality relies on physical hardware for measurement.
Yes, this device is an IVD (In Vitro Diagnostic).
The Intended Use section 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."
The Device Description also refers to the system as "an in vitro diagnostic device intended for the measurement of glucose in capillary blood."
N/A
Intended Use / Indications for Use
The Bioland Blood Glucose Monitoring System is comprised of Bioland Blood Glucose Meter and Bioland Blood Glucose Test Strips.
The Bioland 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 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 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The Bioland 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 Blood Glucose Monitoring System (hereafter as the System) is an in vitro diagnostic device intended for the measurement of glucose in capillary blood. The System consists of the Bioland Blood Glucose Meter, Bioland Blood Glucose Test Strips, lancing device / sterile lancet and Bioland Glucose Control Solution. The Bioland Glucose Control Solution is for use with the Bioland Blood Glucose Meter and Bioland Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. These products have been designed and tested to work together as a system to produce accurate blood glucose test results. The measured result can be transferred to the appointed equipment that has been connected via the Bluetooth function.
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)
Altitude study:
The testing results show the individual bias is less than ±10 % compared with the mean value of Glucose Analyzer YSI 2300 from altitude 298 feet (91 m) to 10,744 feet (3,275 m). The SD at blood glucose concentration 75 mg/dL. The test results meet the acceptance criteria. The Bioland Blood Glucose Monitoring System passes the Robustness validation study.
Short volume detection testing:
Under the directions CLSI EP7-A2 and FDA Guideline "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" issued on October 11, 2016. The test results met the acceptance criteria by applying the blood volume ≥ 0.7uL. The volume of blood sample required at least 0.7uL for Bioland Blood Glucose Monitoring System G-427B. If the blood volume is not enough, the device will detect this shortage situation, and the 5-second countdown procedure is not to start.
System operation conditions testing:
The study was performed in accordance with guidelines of ISO 23640:2011 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents. According to the test results, the bias or bias % was less than 10 mg/dL or 10% and CV/SD were less than 5.0% / 5.0 mg/dL. The test results met the acceptance criteria. So we can acclaim that the system operating conditions for the subject device are 50 °F - 104 °F, 15% - 85% RH.
Equipment temperature exposure limits for storage testing:
The study was performed in accordance with guideline of EN ISO 15197:2015, Section 5.11: Equipment temperature exposure limits for storage. According to the test results, the function and repeatability of the meters after being treated to extreme temperature, -4 °F or 131 °F fall within the acceptance criteria. That is, the meters could stand the extreme temperature (-4 °F to 131 °F), as required in EN ISO 15197:2015.
Equipment humidity exposure limits for storage testing:
The study was performed in accordance with guideline of EN ISO 15197:2015, Section 5.12: Equipment humiditv exposure limits for storage. According to the test results, the function and repeatability of the meters after being treated to extreme humidity, 93±3.0% RH at 89.6 °F, fall within the acceptance criteria. That is, the meters could stand the extreme humidity (93±3% RH, 89.6 °F) as required in EN ISO 15197:2015.
Vibration and Shock Test:
The study was performed in accordance with guideline of IEC 60068-2-64:2008, IEC 61010-1:2010 and EN ISO 15197:2015, Section 5.10: Mechanical resistance to vibration and shock. According to the test results, the function and repeatability after vibration and drop tests fall within the acceptance criteria. That is, the meters could stand the vibration and drop tests required in EN ISO 15197:2015, IEC 60068-2-64:2008 and IEC 61010-1:2010.
Shelf life evaluation:
Two components were evaluated respectively for Bioland Blood Glucose Test Strips and Bioland Glucose Control Solutions. There are two cases to conduct for each component. One case is to evaluate the stability of first opening vial in real-time study and another case is shelf life evaluation for unopened vial in real-time study. According to the test results, the unopened vials of the Bioland Blood Glucose Test Strips were stable for 24 months and 90 days for in-use (opened) vials. The unopened vials of the Bioland Glucose Control Solutions were stable for 12 months and 90 days for in-use (opened) vials.
Sample perturbation study:
Under the FDA Guideline "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" issued on October 11, 2016 and CLSI EP7-A2, the results show the sampling perturbation has no significant effect on precise blood glucose measurement for Bioland Blood Glucose Monitoring System.
Testing with used strips:
Under the directions of FDA Guideline "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" issued on October 11, 2016, the test results showed when the Bioland Blood Glucose Monitoring System is tested with a used test strip, the System will not provide any measurement data, and the 5-second countdown will not activate.
User performance study (Lay user study):
This User performance study was conducted under the directions of FDA Guideline "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" issued on October 11, 2016. After a certain period of reading user manual, the Bioland Blood Glucose Monitoring System G-427B can be operated properly by a lay user. The test results show that the populations of individual bias ±15% for glucose concentration across the entire range are over 95%. The test results meet the acceptance criteria. We claim that the Bioland Blood Glucose Monitoring System can be operated properly by lay users even in the case of the absence of any guidance.
Satisfaction evaluation:
More than 85% of volunteers agree that the labels on the packing and the user manual provided enough information of the product for the readers. More than 95 % of volunteers' score were higher than 80 points. It indicates that the written materials could provide enough information of the product for the lay users, so they can comprehend the contents easily even without the explanation from the professionals.
Usability engineering file:
This usability engineering file is prepared in accordance with EN 60601-1-6: 2010 (IEC 60601-1-6: 2010) and EN 62366: 2008 (IEC 62366: 2007). It contains the records/documents generated for usability engineering process activities. After reviewing the records of usability validation activities, evidence shows that there is no usability problem when validated under normal condition and the worst case scenarios.
Virucidal efficacy against Hepatitis B surface Antigen (HBsAg):
Virucidal efficacy against Hepatitis B surface Antigen (HBsAg) by the Clorox Germicidal Wipes disinfectant is conducted on the following parts: On main housing materials of ABS, On test slot (port) of PMMA (transparent), and On LCD display lens of PC (transparent). The results passed the acceptance criteria for three parts of the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
User performance study (Lay user study):
Summary of data within specified mg/dL of the comparator method for glucose concentrations across the entire range:
Within ±5% : 173/351 ( 49.29% )
Within ±10% : 293/351 ( 83.48% )
Within ±15% : 346/351 ( 98.58% )
Within ±20% : 351/351 ( 100% )
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 & 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.
March 20, 2020
Bioland Technology Ltd. % Ke-Min Jen No. A6B7 (Block G), ShangRong Industrial Zone No. 5 Baolong Road, Baolong Community, Longgang District, Shenzhen, CN 518116 Guangdong
Re: K191657
Trade/Device Name: Bioland Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: June 12, 2019 Received: June 21, 2019
Dear Ke-Min Jen:
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 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
1
- 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 (OS) 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.
Marianela Perez-torres -S
Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191657
Device Name Bioland Blood Glucose Monitoring System
Indications for Use (Describe)
The Bioland Blood Glucose Monitoring System is comprised of Bioland Blood Glucose Meter and Bioland Blood Glucose Test Strips.
The Bioland 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 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 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The Bioland 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) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image contains the word "bioland" in blue font, followed by three Chinese characters. The characters are also in blue and appear to be part of the brand name. There is a small registered trademark symbol next to the "d" in "bioland" and another one next to the last Chinese character.
有 爱 有 快 乐
Telephone: +86 755 2896 1218 Facsimile: +86 755 2896 2868 Website: http:// www.bioland.com.cn
Bioland Technology Ltd.
No. A6B7 (Block G), ShangRong Industrial Zone No.5 Baolong Road, Baolong Community, Longgang District 518116 Shenzhen, Guangdong, People's Republic of China
5. 510(k) Summary (Per 21 CFR 807.92) 510(k) number: K191657
| Type of 510(k) submission | Traditional |
|---|---|
| Basis for the submission | A New Device |
| Common Name of the Proposed | |
| Device | Self-Monitoring Blood Glucose Test Systems |
| Trade name | Bioland Blood Glucose Monitoring System |
| 510(k) submitter | Bioland Technology Ltd. |
| No. A6B7 (Block G), ShangRong Industrial Zone | |
| No. 5 Baolong Road, Baolong Community, Longgan | |
| District 518116, Shenzhen, Guangdong, People's | |
| Republic of China | |
| Website: http://www.bioland.com.cn | |
| Email: bioland-c@bioland.com.cn | |
| Phone: +86-755-2896-1218 | |
| Fax: +86-755-2896-2868 | |
| Registered Establishment Number | 3004101980 |
| Owner number | 9057599 |
| Date prepared | March 17, 2020 |
| Contact person | Dr. JEN, KE-MIN |
| TEL: +886-3-5208829 FAX: +886-3-5209783 | |
| Email: ceirs.jen@msa.hinet.net | |
| Preference for continued | |
| confidentiality (21 CFR 807.95) | 510(k) Summary |
| Classification regulation | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE |
| COUNTER (21 CFR 862.1345) | |
| Class | 2 |
| Panel | Clinical Chemistry |
| Product code | NBW |
| Predicate Device | Manufacturer: Bioland Technology Ltd. |
| Proprietary name: Bioland G-423 Blood Glucose Monitoring System | |
| 510(k) number: K113077 |
4
Telephone: +86 755 2896 1218 Facsimile: +86 755 2896 2868 Website: http:// www.bioland.com.cn
Bioland Technology Ltd.
No. A6B7 (Block G), ShangRong Industrial Zone No.5 Baolong Road, Baolong Community, Longgang District 518116 Shenzhen. Guangdong. People's Republic of China
● Indications For Use:
The Bioland Blood Glucose Monitoring System is comprised of Bioland Blood Glucose Meter and Bioland Blood Glucose Test Strips.
The Bioland 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 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 Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. The Bioland Blood Glucose Monitoring System is not for use in neonates.
● Device Description:
The Bioland Blood Glucose Monitoring System (hereafter as the System) is an in vitro diagnostic device intended for the measurement of glucose in capillary blood. The System consists of the Bioland Blood Glucose Meter, Bioland Blood Glucose Test Strips, lancing device / sterile lancet and Bioland Glucose Control Solution. The Bioland Glucose Control Solution is for use with the Bioland Blood Glucose Meter and Bioland Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. These products have been designed and tested to work together as a system to produce accurate blood glucose test results. The measured result can be transferred to the appointed equipment that has been connected via the Bluetooth function.
● Test Principle
Electrochemical biosensor with carbon electrodes that is referring to detection of glucose by the test strips. The test is based on the measurement of electrical current generated by the reaction of capillary whole blood glucose with glucose oxidase on the test strip. The meter measures the strength of the current which is proportional to the concentration of glucose present and displays the corresponding blood glucose level.
5
Image /page/5/Picture/0 description: The image contains the word "bioland" in blue, followed by Chinese characters. The Chinese characters are also in blue and appear to be a translation or a related term to "bioland". The font is sans-serif and the overall design is simple and clean. There are two circled R symbols on the top right of the words.
有 爱 有 快 乐
Telephone: +86 755 2896 1218 Facsimile: +86 755 2896 2868 Website: http:// www.bioland.com.cn
● Comparison Table
Bioland Technology Ltd.
No. A6B7 (Block G), ShangRong Industrial Zone No.5 Baolong Road, Baolong Community, Longgang District 518116 Shenzhen, Guangdong, People's Republic of China
| Comparison
| Items | Predicate device | Subject device | Verdict |
|---|---|---|---|
| Manufacturer | Bioland Technology Ltd. | Bioland Technology Ltd. | Same |
| Device name | |||
| model number | Bioland Blood Glucose | ||
| Monitoring System, G-423 | Bioland Blood Glucose | ||
| Monitoring System, G-427B | Similar | ||
| Product Code | NBW | NBW | Same |
| 510(k) Number | K113077 | K191657 | -- |
| Indications for | |||
| Use (IFU) | Intended to be used for the | ||
| 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. | Intended to be used for the | ||
| 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. | Same | ||
| Test Principle | Electrochemical biosensor with | ||
| carbon electrodes that is | |||
| referring to detection of glucose | |||
| by the test strips. The test is | |||
| based on the measurement of | |||
| electrical current generated by | |||
| the reaction of capillary whole | |||
| blood glucose with glucose | |||
| oxidase on the test strip. The | |||
| meter measures the strength of | |||
| the current which is proportional | |||
| to the concentration of glucose | |||
| present and displays the | |||
| corresponding blood glucose | |||
| level. | Electrochemical biosensor with | ||
| carbon electrodes that is | |||
| referring to detection of glucose | |||
| by the test strips. The test is | |||
| based on the measurement of | |||
| electrical current generated by | |||
| the reaction of capillary whole | |||
| blood glucose with glucose | |||
| oxidase on the test strip. The | |||
| meter measures the strength of | |||
| the current which is proportional | |||
| to the concentration of glucose | |||
| present and displays the | |||
| corresponding blood glucose | |||
| level. | Same | ||
| Enzyme | Glucose oxidase | Glucose oxidase | Same |
| Measuring | |||
| method | Amperometric technology using | ||
| glucose oxidase | Amperometric technology using | ||
| glucose oxidase | Same | ||
| Display | LCD | LCD with backlight | Similar |
| Specimen type | Capillary whole blood from | ||
| fingertip | Capillary whole blood from | ||
| fingertip | Same | ||
| Detecting Range | 20 ~ 600 mg/dL | 40 ~ 600 mg/dL | Similar |
| Operating | |||
| conditions | 50°F~104°F (10 °C ~ 40 °C) | ||
| Humidity 75 mg/dL. The test results meet the acceptance criteria. The Bioland Blood Glucose Monitoring System passes the Robustness validation study. |
. Short volume detection testing:
Under the directions CLSI EP7-A2 and FDA Guideline "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" issued on October 11, 2016. The test results met the acceptance criteria by applying the blood volume ≥ 0.7uL. The volume of blood sample required at least 0.7uL for Bioland Blood Glucose Monitoring System G-427B. If the blood volume is not enough, the device will detect this shortage situation, and the 5-second countdown procedure is not to start.
. System operation conditions testing
The study was performed in accordance with guidelines of ISO 23640:2011 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents. According to the test results, the bias or bias % was less than 10 mg/dL or 10% and CV/SD were less than 5.0% / 5.0 mg/dL. The test results met the acceptance criteria. So we can acclaim that the system operating conditions for the subject device are 50 °F - 104 °F, 15% - 85% RH.
. Equipment temperature exposure limits for storage testing
The study was performed in accordance with guideline of EN ISO 15197:2015, Section 5.11: Equipment temperature exposure limits for storage. According to the test results, the function and repeatability of the meters after being treated to extreme temperature, -4 °F or 131 °F fall within the acceptance criteria. That is, the meters could stand the extreme temperature (-4 °F to 131 °F), as required in EN ISO 15197:2015.
. Equipment humidity exposure limits for storage testing
The study was performed in accordance with guideline of EN ISO 15197:2015, Section 5.12: Equipment humiditv exposure limits for storage. According to the test results, the function and repeatability of the meters after being treated to extreme humidity, 93±3.0% RH at 89.6 °F, fall within the acceptance criteria. That is, the meters could stand the extreme humidity (93±3% RH, 89.6 °F) as required in EN ISO 15197:2015.
13
Image /page/13/Picture/0 description: The image shows the word "bioland" in blue, followed by Chinese characters. The word "bioland" is in lowercase letters, and the Chinese characters are in a similar blue color. There is a registered trademark symbol next to the word "bioland" and the Chinese characters. The text is likely a logo or brand name.
Telephone: +86 755 2896 1218 Facsimile: +86 755 2896 2868 Website: http:// www.bioland.com.cn
有 爱
Bioland Technology Ltd.
No. A6B7 (Block G), ShangRong Industrial Zone No.5 Baolong Road, Baolong Community, Longgang District 518116 Shenzhen. Guangdong. People's Republic of China
. Vibration and Shock Test
The study was performed in accordance with guideline of IEC 60068-2-64:2008, IEC 61010-1:2010 and EN ISO 15197:2015, Section 5.10: Mechanical resistance to vibration and shock. According to the test results, the function and repeatability after vibration and drop tests fall within the acceptance criteria. That is, the meters could stand the vibration and drop tests required in EN ISO 15197:2015, IEC 60068-2-64:2008 and IEC 61010-1:2010.
. Shelf life evaluation:
The study was performed in accordance with guidelines of ISO 23640:2011. Two components were evaluated respectively for Bioland Blood Glucose Test Strips and Bioland Glucose Control Solutions. There are two cases to conduct for each component. One case is to evaluate the stability of first opening vial in real-time study and another case is shelf life evaluation for unopened vial in real-time study. According to the test results, the unopened vials of the Bioland Blood Glucose Test Strips were stable for 24 months and 90 days for in-use (opened) vials. The unopened vials of the Bioland Glucose Control Solutions were stable for 12 months and 90 days for in-use (opened) vials.
. Sample perturbation study:
Sample perturbation occurs when a user has applied an appropriate volume of blood to the test strip for glucose measurement but an event such as wicking of blood away from the test strip, flicking of the test strip or flicking of the meter occurs during the start of measurement. Under the FDA Guideline "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" issued on October 11, 2016 and CLSI EP7-A2, the results show the sampling perturbation has no significant effect on precise blood glucose measurement for Bioland Blood Glucose Monitoring System.
. Testing with used strips:
Under the directions of FDA Guideline "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" issued on October 11, 2016, the test results showed when the Bioland Blood Glucose Monitoring System is tested with a used test strip, the System will not provide any measurement data, and the 5-second countdown will not activate.
14
Image /page/14/Picture/0 description: The image shows the word "bioland" in blue, followed by three Chinese characters, also in blue. The font is sans-serif and the text is left-aligned. There is a trademark symbol to the right of the word "bioland" and above the Chinese characters.
有 爱 有 快 乐
Telephone: +86 755 2896 1218 Facsimile: +86 755 2896 2868 Website: http:// www.bioland.com.cn
Bioland Technology Ltd.
No. A6B7 (Block G), ShangRong Industrial Zone No.5 Baolong Road, Baolong Community, Longgang District 518116 Shenzhen, Guangdong, People's Republic of China
. User performance study (Lay user study):
This User performance study was conducted under the directions of FDA Guideline "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use" issued on October 11, 2016. After a certain period of reading user manual, the Bioland Blood Glucose Monitoring System G-427B can be operated properly by a lay user. The test results show that the populations of individual bias ±15% for glucose concentration across the entire range are over 95%. The test results meet the acceptance criteria. We claim that the Bioland Blood Glucose Monitoring System can be operated properly by lay users even in the case of the absence of any guidance.
Summary of data within specified mg/dL of the comparator method for glucose concentrations across the entire range:
| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
|---|---|---|---|
| 173/351 ( 49.29% ) | 293/351 ( 83.48% ) | 346/351 ( 98.58% ) | 351/351 ( 100% ) |
. Satisfaction evaluation
More than 85% of volunteers agree that the labels on the packing and the user manual provided enough information of the product for the readers. More than 95 % of volunteers' score were higher than 80 points. It indicates that the written materials could provide enough information of the product for the lay users, so they can comprehend the contents easily even without the explanation from the professionals.
. Usability engineering file:
This usability engineering file is prepared in accordance with EN 60601-1-6: 2010 (IEC 60601-1-6: 2010) and EN 62366: 2008 (IEC 62366: 2007). It contains the records/documents generated for usability engineering process activities. After reviewing the records of usability validation activities, evidence shows that there is no usability problem when validated under normal condition and the worst case scenarios.
- . Virucidal efficacy against Hepatitis B surface Antigen (HBsAg) by the Clorox Germicidal Wipes disinfectant is conducted on the following parts:
- On main housing materials of ABS,
- On test slot (port) of PMMA (transparent), and
- On LCD display lens of PC (transparent).
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Image /page/15/Picture/0 description: The image shows the word "bioland" in blue, followed by three Chinese characters that also appear in blue. There is a registered trademark symbol to the upper right of the "d" in "bioland", and another registered trademark symbol to the upper right of the last Chinese character. The font is sans-serif and the overall design is simple and clean.
Telephone: +86 755 2896 1218 Facsimile: +86 755 2896 2868 Website: http:// www.bioland.com.cn
Bioland Technology Ltd.
No. A6B7 (Block G), ShangRong Industrial Zone No.5 Baolong Road, Baolong Community, Longgang District 518116 Shenzhen, Guangdong, People's Republic of China
The results passed the acceptance criteria for three parts of the subject device.
● Conclusions
The conclusions drawn from the non-clinical and clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device identified in the submission. Thus, the subject device is substantially equivalent to the predicate device.