GLUCOCARD® W onyx Blood Glucose Monitoring System

K183306 · Arkray Factory, Inc. · NBW · Apr 10, 2019 · Clinical Chemistry

Device Facts

• Record ID: K183306
• Device Name: GLUCOCARD® W onyx Blood Glucose Monitoring System
• Applicant: Arkray Factory, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 10, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GLUCOCARD® W onyx Blood Glucose Monitoring System is comprised of GLUCOCARD® W onyx Blood Glucose Meter and disposable GLUCOCARD® W Blood Glucose Test Strips. The GLUCOCARD® W onyx Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip or palm. Testing is done outside the body (in vitro diagnostic use). It is intended for use at home by persons with diabetes, as an aid in monitoring the effectiveness of a diabetes control program. The GLUCOCARD® W onyx Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

Device Story

System measures glucose in fresh capillary whole blood via electrochemical biosensor technology using glucose oxidase enzyme. Input: capillary blood sample on disposable test strip; Output: plasma-equivalent glucose concentration displayed on meter. Used at home by patients with diabetes. Features: auto-coding for lot sensitivity, temperature correction, hematocrit correction, sample auto-detection (blood vs. control), and sensor insertion/removal detection. Data transmission via USB or Bluetooth to mobile devices. Output aids patients in monitoring diabetes control program effectiveness. Device redesign from predicate includes Bluetooth module, larger form factor, negative segment display with backlight, and sensor port light.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and comparison of technological characteristics.

Technological Characteristics

Electrochemical glucose monitoring. Power: 2 x 1.5V AAA batteries. Connectivity: Bluetooth 4.0. Display: Backlit, white font on black background. Features: Test strip port light, user-settable flags. Materials validated for 160 cleaning/disinfection cycles.

Indications for Use

Indicated for single patient home 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

• GLUCOCARD® W Blood Glucose Monitoring System (K170064)

Submission Summary (Full Text)

{0}

SPECIAL 510(K): DEVICE MODIFICATION OIR DECISION SUMMARY

510(k) Number: k183306

This 510(k) submission contains information/data on modifications made to the applicant’s own class II or class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the applicant’s previously cleared device: GLUCOCARD® W Blood Glucose Monitoring System (k170064).

2. Applicant’s statement that the INDICATION/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 the following:

- Addition of Bluetooth 4.0 wireless communication function
- Addition of user-settable hyperglycemia indicators, bedtime and daylight savings time flags
- Increase in meter size and weight
- Change of button material and position
- Addition of backlight to display and change in display from black font on white background to white font on black background
- Change from 1 x 3 lithium battery (CR2032) to 3-volt LR03/2 x 1.5 AAA
- Addition of test strip port light
- Change in device system name from GLUCOCARD W Blood Glucose Monitoring System to GLUCOCARD W onyx Blood Glucose Monitoring System

4. Comparison Information (similarities and differences) to applicant’s legally marketed predicate device including, labeling, intended use, physical characteristics, and component design.

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

{1}

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 applicant’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 applicant 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 GLUCOCARD W onyx Blood Glucose Monitoring System is intended for single patient home use. Disinfection efficacy studies were performed on the external materials comprising the meter by an outside commercial testing laboratory demonstrating complete inactivation of hepatitis B virus (HBV) with the chosen disinfectant, Clorox Germicidal Wipe (EPA Reg. No: 67619-12). The sponsor also conducted robustness studies and demonstrated that there was no change in performance or in the external materials of the meter after 160 cleaning and disinfection cycles representing 3 years of single patient use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.

2