GlucoSure ADVANCE Link Blood Glucose Monitoring System

K222234 · Apex BioTechnology Corp. · NBW · Dec 21, 2022 · Clinical Chemistry

Device Facts

• Record ID: K222234
• Device Name: GlucoSure ADVANCE Link Blood Glucose Monitoring System
• Applicant: Apex BioTechnology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 21, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The GlucoSure ADVANCE Link Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use. The GlucoSure ADVANCE Link Blood Glucose Monitoring System is comprised of the GlucoSure ADVANCE Link Blood Glucose Meter and GlucoSure ADVANCE Link Blood Glucose Test Strips.

Device Story

System measures glucose in capillary blood via test strips; electrochemical sensing principle. User inserts strip into meter; applies blood sample; meter calculates glucose concentration using established algorithm. Designed for home self-testing by patients with diabetes. New feature: Bluetooth connectivity for wireless data transfer to mobile devices. Meter displays results; stores up to 700 results. Provides error messages for Bluetooth failures (Er5-Er8). Benefits: enables convenient tracking of glucose levels to manage diabetes. Healthcare providers review stored data to assess treatment effectiveness.

Clinical Evidence

Usability study conducted to confirm system accuracy, operation according to design, and ease of use. No clinical diagnostic performance data (e.g., sensitivity/specificity) provided in summary; relies on bench testing and usability validation.

Technological Characteristics

Electrochemical glucose test system. Components: meter, test strips, control solution. Connectivity: Bluetooth for mobile data transfer. Power: Battery-operated. Software: Embedded firmware with Bluetooth communication and data storage. Materials: Identical to predicate BGM014 (previously cleared).

Indications for Use

Indicated for single-patient use as a blood glucose monitoring system for the quantitative measurement of glucose in capillary whole blood.

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

• BGM014 Blood Glucose Monitoring System (K161299)

Submission Summary (Full Text)

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SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY

I Background Information:

A 510(k) Number
K222234

B Applicant
Apex BioTechnology Corp.

C Proprietary and Established Names
GlucoSure ADVANCE 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.
BGM014 Blood Glucose Monitoring System, K161299

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. The modifications are listed below:

- Bluetooth Low Energy (BLE) connectivity was added to the meter along with the associated addition of the Bluetooth icon to the meter display and the addition of Bluetooth related error messages.
- The color of the test strip ejection button was changed from gray to white and the color on the backside of the meter display cover was changed from grey to blue.
- The control solution test process was changed from 4 steps to 3 steps.
- The meter memory was decreased from 1000 to 700 test results.
- The battery life claim was decreased from 1000 tests to 750 tests.
- The device system name was changed from BGM014 Blood Glucose Monitoring System to GlucoSure ADVANCE Link Blood Glucose Monitoring System.
- The meter name was changed from BGM014 Blood Glucose Meter to GlucoSure ADVANCE Link Blood Glucose Meter.
- The test strip name was changed from BGM014 Blood Glucose Test Strips to GlucoSure ADVANCE Link Blood Glucose Test Strips.

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 by outside testing laboratories demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant products including: Dispatch® Hospital Cleaner Disinfectant Towels with Bleach (EPA Reg#56392-8) (K113098, K143750), Clorox Healthcare® Bleach Germicidal and Disinfectant Wipes (EPA#67619-12) (K131750), Medline Micro-Kill+™ Bleach Germicidal Bleach Wipes (EPA#69687-1-37549) (K150396), Medline Micro-Kill+™ Disinfecting, Deodorizing, Cleaning Wipes with Alcohol (EPA#59894-10) (K150396, K143750), and Super Sani-Cloth® Germicidal Disposal Wipe (EPA#9480-4) (K182992). Robustness studies were also previously performed by

Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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the sponsor (K161299 and K182992) demonstrating that there was no change in performance or external materials of the meter after 1825 cleaning and disinfection cycles with the chosen wipes described above. The robustness studies were designed to support 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
K222234 - Page 3 of 3