GAL-1A Plus Blood Glucose Monitoring System

K213887 · Apex BioTechnology Corp. · NBW · Mar 29, 2022 · Clinical Chemistry

Device Facts

• Record ID: K213887
• Device Name: GAL-1A Plus Blood Glucose Monitoring System
• Applicant: Apex BioTechnology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 29, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The GAL-1A Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger. The system is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not for use on neonates.

Device Story

The GAL-1A Plus Blood Glucose Monitoring System is an in vitro diagnostic device for home use by patients with diabetes. It measures glucose levels in fresh capillary whole blood samples obtained from the finger. The system consists of a handheld meter and test strips. The user applies a blood sample to the test strip, which the meter analyzes to provide a quantitative glucose concentration reading. This output assists patients in monitoring their diabetes management. The device is intended for single-patient use. The current modification involves changes to the meter's physical form factor (shape changed from rectangle to oval) and aesthetic appearance (color changed from black and white to gray), while maintaining the fundamental scientific technology of the previously cleared GAL-1A system.

Clinical Evidence

No new clinical data provided. Substantial equivalence is supported by design control activities, risk analysis, and verification/validation of the physical modifications. Disinfection efficacy and robustness studies (1825 cycles over 5 years) were previously established and maintained.

Technological Characteristics

Glucose test system (21 CFR 862.1345). Electrochemical sensing principle. Handheld meter with oval form factor (77Lx51Wx14H mm). Uses same test strips and algorithm as predicate device. No software or connectivity features described.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from the finger for single-patient use by individuals with diabetes to monitor glycemic control. Not for neonatal use or diabetes diagnosis/screening.

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

• GAL-1A Blood Glucose System (k113208)

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

K213887

B Applicant

Apex BioTechnology Corp.

C Proprietary and Established Names

GAL-1A 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. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.): GAL-1A Blood Glucose Monitoring System, (k113208)

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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- The meter case shape was changed from rectangle to oval
- The color of meter case was changed from black and white to gray
- The device trade name was changed from GAL-1A Blood Glucose Monitoring System to GAL-1A Plus 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 (k113208) demonstrating complete inactivation of hepatitis B virus (HBV) with the Dispatch towel (EPA Reg# 56392-8). A robustness study was performed by the sponsor to demonstrate that the meter is robust to one cleaning and one disinfection cycle per day over a 5-year use life of the meter (1825 cycles). Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

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