GlucoSure HT Plus Blood Glucose Monitoring System

K202885 · Apex BioTechnology Corp. · NBW · Sep 15, 2021 · Clinical Chemistry

Device Facts

• Record ID: K202885
• Device Name: GlucoSure HT Plus Blood Glucose Monitoring System
• Applicant: Apex BioTechnology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Sep 15, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

GlucoSure HT Plus Blood Glucose Monitoring System is intended to quantitatively measure blood glucose in fresh capillary whole blood drawn from fingertips, palm, or forearm. Alternative site testing for glucose test should be performed only during steady-state (when glucose is not changing rapidly). It is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use. The GlucoSure HT Blood Glucose Test Strips are to be used with the GlucoSure HT Plus Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

Device Story

System consists of GlucoSure HT Plus meter and test strips; used by patients with diabetes at home for self-monitoring of blood glucose levels. Input: fresh capillary whole blood sample applied to test strip. Principle: electrochemical measurement of glucose concentration. Output: digital glucose reading displayed on meter LCD. Device features strip ejection button, backlight, and memory for 500 readings with averages. User interface includes meal/event tagging and hypo/hyperglycemic settings. Benefits: aids patients in monitoring diabetes control effectiveness. Operation: patient applies blood to strip; meter processes sample and displays result. Data management: stores readings for longitudinal tracking.

Clinical Evidence

User studies conducted with home users to evaluate ease of use and comprehension of the user manual. Results demonstrate performance substantially equivalent to the predicate system.

Technological Characteristics

Handheld glucose meter; electrochemical sensing principle; powered by two CR2032 lithium batteries; dimensions 96x58x16 mm; LCD display with backlight; memory capacity 500 results; includes strip ejection mechanism. Materials validated for 260 cleaning/disinfection cycles using Clorox Healthcare Bleach Germicidal Wipes.

Indications for Use

Indicated for the quantitative measurement of glucose in capillary whole blood from the fingertip, palm, or forearm by people with diabetes as an aid in monitoring the effectiveness of a diabetes control program. The system is intended for single-patient use only.

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

• BGM009 Plus Blood Glucose System (K170267)

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

K202885

B Applicant

Apex BioTechnology Corp.

C Proprietary and Established Names

GlucoSure HT Plus 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. BGM009 Plus Blood Glucose System, K170267. (For a preamendments device, a statement to this effect has been provided.)
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 device has not changed. This change was for:

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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- Dimensions of the meter were changed from 93x58x20.5 (mm) to 96x58x16 (mm)
- Added strip ejection button.
- Change of power source from two AAA batteries to two CR2032 lithium batteries.
- LCD size changed, added new icons and back light.
- The meter memory capacity was changed from 300 to 500 test results and added 1, 60, 90 day averaging feature.
- Addition of before meal, after meal, exercise, and event icons.
- Hypoglycemia and hyperglycemia warnings were added to the meter.
- Reorganized the definitions of error codes.
- Changed the product name from BGM009 Plus Blood Glucose Monitoring System to GlucoSure HT Plus Blood Glucose Monitoring System.
- Added individually wrapped test strips for use with the 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 (k182593) demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant Clorox Healthcare Bleach Germicidal Wipes (EPA Registration Number: 67619-12). A robustness study was performed by the sponsor demonstrating that there was no change in performance or in external materials of the meter after 260 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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