BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System

K220421 · Apex BioTechnology Corp. · NBW · Nov 4, 2022 · Clinical Chemistry

Device Facts

• Record ID: K220421
• Device Name: BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System
• Applicant: Apex BioTechnology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 4, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device system is intended for single-patient use only.

Device Story

BGM039 and BGM039 Link are blood glucose monitoring systems for home self-testing by patients with diabetes. Systems consist of a meter and single-use test strips. Input: fresh capillary whole blood sample applied to test strip. Operation: electrochemical measurement of glucose concentration; BGM039 Link includes Bluetooth module for wireless data transfer to mobile devices. Output: quantitative blood glucose level displayed on meter LCD. Healthcare providers use output to monitor diabetes control effectiveness. Benefits: enables patient self-monitoring of glucose levels to manage diabetes. BGM039 Link adds wireless connectivity; BGM039 is the base model without Bluetooth. Both models use the same test strips and core glucose measurement algorithm as the predicate.

Clinical Evidence

No clinical testing was conducted. Substantial equivalence is supported by non-clinical bench testing, including robustness, drop, battery life, linearity, intermediate precision, within-run precision, accuracy, usability, EMC, electrical safety, and software verification/validation.

Technological Characteristics

Glucose test system (21 CFR 862.1345). Electrochemical sensing principle. Uses single-use test strips. BGM039 Link includes Bluetooth module for wireless connectivity. Dimensions: 86Lx58Wx18H (mm). Software includes Bluetooth communication and error messaging (Err5-Err8).

Indications for Use

Indicated for single-patient use for blood glucose monitoring.

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

• GlucoSure HT Plus Blood Glucose Monitoring System (K202885)

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

K220421

B Applicant

Apex BioTechnology Corp.

C Proprietary and Established Names

BGM039 Blood Glucose Monitoring System

BGM039 Link 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: GlucoSure HT Plus Blood Glucose Monitoring System, K202885.
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

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for:

- Changes common to both the BGM039 and BGM039 Link Blood Glucose Meters:
- Change in meter dimensions from 96Lx58Wx16H (mm) to 86Lx58Wx18H (mm)
- Removal of the test strip ejection button and removal of the USB port and functionality
- Change in the position of all the buttons from the front to the side of the meter and a change in the position of the test strip port from the top to the bottom of the meter
- Changes to the color of the buttons, the battery cover, and the upper and lower case of the meter
- Changes to the circuit and to the microcontroller unit

- Addition of Bluetooth functionality to the BGM039 Link Blood Glucose System only including associated meter display changes and the addition of Bluetooth pairing and data transmission related error massages
- The device name was changed from GlucoSure HT Plus Blood Glucose Monitoring System to BGM039 Blood Glucose Monitoring System or BGM039 Link Blood Glucose Monitoring System

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 system is intended for single-patient use only. Disinfection efficacy studies were previously performed on the exterior meter materials (K50396) demonstrating complete inactivation of hepatitis B virus (HBV) with Clorox Healthcare Bleach Germicidal Wipes (EPA Reg. No.:67619-12). A robustness study was performed by the sponsor to demonstrate that the meter is robust to one cleaning and one disinfection cycle per week over a 5-year use life of the meter (260 cycles). Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

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