EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014

K061992 · Eps Bio Technology Corp. · CGA · Sep 19, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061992
• Device Name: EASYPLUS SELF MONITORING GLUCOSE TEST SYSTEM, MODEL EPS04014
• Applicant: Eps Bio Technology Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Sep 19, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

The EasyPlus Self-Monitoring Blood Glucose System is used by individuals with diabetes. It is for the quantitative measurement of glucose levels in fresh capillary whole blood from fingerstick, as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings.

Device Story

EasyPlus Self-Monitoring Blood Glucose System; electrochemical biosensor for quantitative glucose measurement. Input: fresh capillary whole blood applied to disposable dry reagent strip. Operation: glucose oxidase (Aspergillus niger) catalyzes glucose oxidation; mediator transfers electrons to carbon electrode; current generated proportional to glucose concentration. Output: glucose concentration displayed on meter screen after 5 seconds. Used in home or clinical settings by patients or healthcare professionals. System includes meter, test strips, auto lancet, check strip, code card, and control solutions. Provides quantitative data to assist in diabetes management monitoring.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures (21 CFR 820.30) and FMEA risk analysis to confirm performance following hardware and software modifications.

Technological Characteristics

Glucose oxidase electrochemical sensing; capillary whole blood sample; meter housing with LCD; modified amplifier gain settings; test strips (color changed from white to blue).

Indications for Use

Indicated for use by patients for the quantitative measurement of glucose in capillary whole blood from the fingerstick.

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

• Easy Pain Supreme Self Monitoring Blood Glucose System (k043245)

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k061992

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.) Easy Pain Supreme Blood Glucose Monitoring System k043245
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

Hardware (meter housing, LCD, position of on/off button), software (reduction in amplifier gain setting), change color of the test strip from white to blue, control solution glucose concentration.

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

Differences: change in amplifier gain settings, hardware, test strip color change from white to blue, reportable range change from 40-600 mg/dL to 30-550 mg/dL.

Similarities: algorithm for calculation of glucose value, glucose oxidase test methodology, capillary whole blood from fingerstick, sample volume

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 The sponsor performed a Failure Mode Effect Analysis(FMEA.)
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.