GlucoLeader Enhance 2 Blood Glucose Monitoring System

K212248 · Hmd Biomedical, Inc. · NBW · Aug 29, 2022 · Clinical Chemistry

Device Facts

• Record ID: K212248
• Device Name: GlucoLeader Enhance 2 Blood Glucose Monitoring System
• Applicant: Hmd Biomedical, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 29, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The device system is intended for single patient use only.

Device Story

System measures glucose in capillary whole blood via amperometric biosensor; requires 0.8 µL sample; 5-second reaction time. Comprises meter, test strips, control solutions, and check strip. Used at home by patients with diabetes; operated by patient or assistant. Meter displays results; aids in monitoring diabetes control effectiveness. Includes Bluetooth Low Energy (BLE) module for wireless data transmission to external devices; transmission occurs post-test under user authorization. Benefits include improved accuracy and HCT interference range (10-70%) via FAD-glucose dehydrogenase enzyme.

Clinical Evidence

No clinical data. Substantial equivalence supported by design control activities, risk analysis, and verification/validation of modifications. Disinfection efficacy and robustness studies (18,250 cycles) were previously established under K182428.

Technological Characteristics

Electrochemical glucose monitoring system. Connectivity: Bluetooth Low Energy (BLE). Materials: exterior meter materials validated for 18,250 cleaning/disinfection cycles using Clorox Germicidal Wipes (EPA Reg. No.: 67619-12).

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

• GlucoLeader Enhance Blood Glucose Monitoring System (K182428)

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

K212248

B Applicant

HMD BioMedical Inc.

C Proprietary and Established Names

GlucoLeader Enhance 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: GlucoLeader Enhance Blood Glucose Monitoring System, K182428.
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:

- Bluetooth Low Energy (BLE) connectivity was added to the meter.
- The meter’s display cover color was changed from blue to green.
- The device name was changed from GlucoLeader Enhance Blood Glucose Monitoring System to GlucoLeader Enhance 2 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 (K182428) by an outside testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant Clorox Germicidal Wipes (EPA Reg. No.: 67619-12). A robustness study was also previously performed by the sponsor demonstrating that there was no change in performance or in external materials of the meter after 18,250 cleaning and disinfection cycles to support 5 years of single-patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

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