EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM

K110435 · U. S. Diagnostics, Inc. · NBW · Sep 21, 2011 · Clinical Chemistry

Device Facts

• Record ID: K110435
• Device Name: EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: U. S. Diagnostics, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Sep 21, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The device is intended for single patient use only.

Device Story

EasyGluco® Plus Blood Glucose Monitoring System; in vitro diagnostic device for home use by patients with diabetes. System consists of a monitor and test strips. Input: fresh capillary whole blood sample applied to test strip. Principle: electrochemical reaction; dehydrogenase glucose in sample reacts with electrodes in strip; generates electrical current proportional to glucose concentration. Meter measures current; displays quantitative glucose result. Used by single patient for self-testing; aids in monitoring diabetes management effectiveness. Provides immediate feedback to patient for glycemic control.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and technological comparison to predicate device.

Technological Characteristics

In vitro diagnostic blood glucose monitor; electrochemical sensing principle using dehydrogenase glucose reaction. System includes handheld meter and disposable test strips. Operates on capillary whole blood samples. No specific materials, connectivity, or software architecture details provided.

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

• G5 Infinity Blood Glucose Monitoring System (k082201)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER: k110435

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) for the EasyGluco Plus Blood Glucose Monitoring System:

1. The name and 510(k) number of SUBMITTER'S previously cleared device: US Diagnostics, Inc., G5 Infinity Blood Glucose Monitoring System, cleared under k082201.
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:

1) Modifications to the design of the meter shape.
2) Change to the graphic design on the test strip.
3) Change in system name to "EasyGluco Plus Blood Glucose Monitoring System".

4. Comparison Information (similarities and differences) to applicant'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
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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 is intended for single patient use only. CaviWipe Disinfecting Towelettes with EPA registration # 46781-8 were validated demonstrating complete inactivation of live Hepatitis B virus for use with the meter and lancing device materials. The sponsor also demonstrated that there was no change in performance or in the external physical appearance of the meter and lancing device after 1825 cleaning and disinfection cycles (1 cycle = 1 cleaning wipe plus 1 disinfection wipe) designed to

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simulate 5 years of device use. Labeling was reviewed for adequate instructions for the validated cleaning and disinfection procedures.