GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System

K142336 · Arkray Factory, Inc. · CGA · Sep 17, 2014 · Clinical Chemistry

Device Facts

• Record ID: K142336
• Device Name: GLUCOCARD 01 Blood Glocose Monitoring System/ReliOn Confirm Blood Glucose Monitoring System
• Applicant: Arkray Factory, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Sep 17, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The GLUCOCARD 01 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home by persons with diabetes 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 intended for use on neonates. It is intended for single patient use and should not be shared with other individuals. The GLUCOCARD 01 SENSOR PLUS Blood Glucose Test Strips are intended to be used with the GLUCOCARD 01 Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm.

Device Story

System comprises blood glucose meter, test strips, and control solution; used by patients with diabetes at home for self-monitoring. Input: fresh capillary whole blood sample applied to test strip. Meter performs electrochemical measurement of glucose concentration; displays quantitative result to user. Output assists patients in tracking diabetes control effectiveness. Modifications in this submission involve changes to exterior meter case materials to support cleaning and disinfection durability. Device is intended for single-patient use.

Clinical Evidence

Bench testing only. Studies included viral elimination effectiveness on meter surfaces, cleaning and disinfection durability testing, drop testing, and button durability studies to validate the robustness of modified exterior materials.

Technological Characteristics

Glucose test system (21 CFR 862.1345). Electrochemical sensing principle. Meter includes modified exterior case materials designed for cleaning and disinfection durability. Standalone device.

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

• GLUCOCARD 01 Blood Glucose Monitoring System and ReliOn Confirm Blood Glucose Monitoring System (K124021)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K142336

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

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.) GLUCOCARD 01 Blood Glucose Monitoring System and ReliOn Confirm Blood Glucose Monitoring System (K124021)
2. Submitter'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: modifications to certain exterior materials of the meters, specifically the lens, body, button plastics, and meter label.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics. Studies performed include viral elimination effectiveness, drop test and meter robustness studies.
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 GLUCOCARD 01 Blood Glucose Monitoring System and ReliOn Confirm Blood Glucose Monitoring System are intended for single-patient use. Disinfection efficacy of the Clorox Healthcare Germicidal Wipes (EPA #67619-12) was validated using materials from the meters demonstrating complete inactivation of duck hepatitis B virus (HBV). The sponsor also performed robustness studies demonstrating that there was no change in performance or in the materials of the meters after 416 cleaning and disinfection cycles designed to simulate a 4-year use life of the device (with 2 cleaning/disinfection cycles per week). The labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.