Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System

K202739 · Bioland Technology, Ltd. · NBW · Aug 12, 2022 · Clinical Chemistry

Device Facts

• Record ID: K202739
• Device Name: Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System
• Applicant: Bioland Technology, Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 12, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The device systems are intended for single-patient use only.

Device Story

Bioland G-425-2V and G-425-2 are blood glucose monitoring systems for home use by patients with diabetes. Devices consist of a meter, test strips, and control solution. Input: fresh capillary whole blood sample (≥0.7uL) applied to test strip. Principle: amperometric biosensor using glucose oxidase enzyme; meter measures electrical current generated by reaction; current signal converted to glucose concentration (40-600 mg/dL). Output: digital display of glucose value; G-425-2V model includes voice broadcast of results. Operated by patient; no Bluetooth connectivity. Results aid in monitoring diabetes control effectiveness. Benefits: provides convenient, quantitative glucose monitoring for home management.

Clinical Evidence

Bench testing only. Verification and validation activities were conducted to assess the impact of hardware and software modifications (removal of Bluetooth, addition of voice feature). All test results met acceptance criteria as documented in the software validation report and risk management report.

Technological Characteristics

Glucose test system (21 CFR 862.1345). Modifications: removal of Bluetooth module; addition of voice synthesis module for G-425-2V. Meter materials validated for 3,650 cleaning/disinfection cycles using EPA-registered bleach wipes. Single-patient use design.

Indications for Use

Indicated for single-patient use for the quantitative measurement of glucose in capillary whole blood from the finger, palm, or forearm. Intended for use by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Bioland Blood Glucose Monitoring System (K191657)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K202739

B Applicant

Bioland Technology Ltd.

C Proprietary and Established Names

Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NBW | Class II | 21 CFR 862.1345 - Glucose Test System | CH - Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: Bioland Blood Glucose Monitoring System, K191657.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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device has not changed. This change was for creating two device systems from the predicate device and included:

- A change to the device trade name from Bioland Blood Glucose Monitoring System to Bioland G-425-2 Blood Glucose Monitoring System and Bioland G-425-2V Blood Glucose Monitoring System.
- The removal of the Bluetooth function from both meters.
- The addition of a voice function to the G-425-2V meter that speaks the result after each blood glucose and control solution test.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

The device systems are intended for single-patient use only. Disinfection efficacy studies were previously performed (K191657) with the external meter materials by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with Clorox Healthcare Bleach Germicidal Wipes (EPA Reg. No: 67619-12). The sponsor also conducted robustness studies demonstrating that there was no change in performance or in the external materials of the meter after 3,650 cleaning and disinfection cycles using the chosen wipe representing 5 years of single patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

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