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.

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;

AI/ML Overview

The provided text describes a 510(k) premarket notification for a Blood Glucose Monitoring System, which is a medical device, not an AI/ML algorithm. Therefore, the information required to answer the prompt regarding AI/ML acceptance criteria and study details (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) is not present in the document.

The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices that are not novel and are similar in intended use, technology, and performance to devices already on the market.

However, I can extract the acceptance criteria related to the device's performance as a blood glucose monitoring system, based on the inherent requirements for such devices, and the general claims of equivalence.

Extracted Information (based on typical blood glucose monitor requirements and general claims):

Device Name: Bioland G-425-2V Blood Glucose Monitoring System and Bioland G-45-2 Blood Glucose Monitoring System
Intended Use: Quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. Not for diagnosis or screening, and not for use in neonates.
Measurement Range: 40~600 mg/dL
Specimen Type: Capillary whole blood from fingertip
Enzyme: Glucose oxidase (indicating an electrochemical detection method)
Test Principle: Amperometric glucose biosensor
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~~104°F (10~~40°C), 15~85%RH
Measuring Time: 6s

Regarding "Acceptance Criteria" for this type of device:

For blood glucose monitors, acceptance criteria are typically defined by accuracy standards (e.g., ISO 15197:2013). While the exact numerical criteria from such standards are not explicitly stated in this document, the submission claims that "All test results met acceptance criteria" in reference to verification and validation activities. The core of the substantial equivalence claim relies on the subject device performing equivalently to the predicate device, which itself would have met relevant performance standards.

Table of Acceptance Criteria and Reported Device Performance:

Since the document does not explicitly list the specific numerical acceptance criteria (e.g., X% of results must be within +/- Y mg/dL of a reference method) nor detailed efficacy performance data, I can only populate the table with the claimed functional equivalence to the predicate device and the general performance specifications provided.

Acceptance Criteria (based on device specifications and implicit equivalence)	Reported Device Performance (as stated in the document, implying compliance)
Intended Use: Quantitative measurement of glucose in fresh capillary whole blood samples from fingertip for self-testing by people with diabetes. Aid to monitor effectiveness of diabetes control. Not for diagnosis/screening, not for neonates.	Met: Bioland G-425-2V Blood Glucose Monitoring System and Bioland G-425-2 Blood Glucose Monitoring System are intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. Intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. Not for diagnosis or screening, not for neonates. Claims substantial equivalence to predicate device (K191657) with identical intended use.
Glucose Measuring Range: 40~600 mg/dL	Met: Detecting Range: 40~600 mg/dL (Identical to predicate device).
Specimen Type: Capillary whole blood from fingertip	Met: Specimen Type: Capillary whole blood from fingertip (Identical to predicate device).
Enzyme: Glucose oxidase	Met: Enzyme: Glucose oxidase (Identical to predicate device).
Test Principle: Amperometric glucose biosensor	Met: Test Principle: Amperometric glucose biosensor (Identical to predicate device). 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.
Hematocrit Range: 20%~60%	Met: Hematocrit Range: 20%~60% (Identical to predicate device).
Sample Volume: ≥0.7uL	Met: Sample Volume: ≥0.7uL (Identical to predicate device).
Measuring Time: 6s	Met: Measuring Time: 6s (Identical to predicate device).
Operating Range (Temperature/Humidity): 10~~40°C (50~~104°F), 15~85%RH	Met: Operating Range: 50~~104°F (10~~40°C), 15~85%RH (Identical to predicate device).
Accuracy / Clinical Performance: The document states "All test results met acceptance criteria" and "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)." This implies that the device successfully passed the required accuracy and clinical performance tests to demonstrate equivalence, which typically involves comparing device readings to a laboratory reference method. Specific numerical accuracy data (e.g., % of results within certain error margins as per ISO 15197) is not provided in this summary document.	Met: The summary states "All test results met acceptance criteria and are included in the software validation report." and "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." The modifications (removal of Bluetooth, addition/removal of voice) are stated to not have changed the glucose algorithm or other core software functions related to measurement accuracy.

Regarding the AI/ML specific questions (for which the document provides NO information):

Sample size used for the test set and the data provenance: Not applicable/Not provided. This is a hardware device with an algorithm, not an AI/ML model being assessed in an independent test set in the way the prompt implies. The testing would be clinical (human subject studies) and analytical (bench testing).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth for a blood glucose monitor is typically established by comparing its readings to a highly accurate laboratory reference method (e.g., YSI analyzer), not by human expert consensus or radiologists.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided. See point 3.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable/Not provided. This is not an AI-assisted diagnostic tool for human readers. It's a direct measurement device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided. The device is the standalone measurement system for the user.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): The ground truth for blood glucose monitoring systems is established by comparison to a laboratory reference method (e.g., YSI Glucose Analyzer) which provides highly accurate and precise glucose concentration measurements. This is intrinsic to the analytical accuracy assessment of blood glucose meters.
The sample size for the training set: Not applicable/Not provided. Blood glucose meters use fixed algorithms based on electrochemistry, not AI/ML models that require training sets in the conventional sense. The "training" would be the initial development and calibration of the chemical and electrical components and the non-AI algorithm.
How the ground truth for the training set was established: Not applicable/Not provided. The ground truth in the development/calibration phase would also be established using highly accurate laboratory reference methods.

In summary: The provided document is a 510(k) summary for a conventional medical device (blood glucose monitor) demonstrating substantial equivalence. It does not pertain to an AI/ML algorithm requiring the specific types of studies and acceptance criteria outlined in the prompt for AI/ML performance. The "study that proves the device meets the acceptance criteria" in this context refers to standard analytical and clinical performance studies required for blood glucose meters, which are implicitly stated to have been successfully completed as part of the overall "verification and validation activities" that showed "All test results met acceptance criteria."

Summary

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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

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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

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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.

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.

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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.

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.

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."

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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

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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 / 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

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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 MonitoringSystem
Intended Use	Quantitative measurement of glucose in capillary whole blood from the fingertip. It isintended for use by people with diabetes mellitus at home (over-the-counter) as an aidin 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~~104°F (10~~40°C), 15~85%RH
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:

1. Trade name
  Change the trade name from Bioland Blood Glucose Monitoring System to Bioland G-425-2V Blood Glucose Monitoring System in labeling;
1. 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

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and other software functions remain unchanged.

1. 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.
1. Interface display
  Delete the icon " ... ", add the icon " (1) " , it is a change in the software.

7.2 Bioland G-425-2 Blood Glucose Monitoring System

Similarities

Item	Predicate DeviceBioland Glucose Monitoring System	Subject DeviceBioland G-425-2 Glucose Monitoring System
Intended Use	Quantitative measurement of glucose in capillary whole blood from the fingertip. It isintended for use by people with diabetes mellitus at home (over-the-counter) as an aidin 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~~104°F (10~~40°C), 15~85%RH
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	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 MonitoringSystem
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:

1. Trade name
  Change the trade name from Bioland Blood Glucose Monitoring System to Bioland G-425-2 Blood Glucose Monitoring System in labeling;
1. 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.
1. Interface display

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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.

Regulation Number and Section

§ 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.