EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO

K133509 · Biotest Medical Corp. · NBW · Feb 21, 2014 · Clinical Chemistry

Device Facts

• Record ID: K133509
• Device Name: EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO
• Applicant: Biotest Medical Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 21, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Easy Plus II Blood Glucose Monitoring System, Easy Plus II Multi Blood Glucose Monitoring System, Smartest Persona II Blood Glucose Monitoring System and Smartest Persona II Multi Blood Glucose Monitoring System are intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger, palm, forearm, upper arm, calf and thigh. The systems are 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. The systems are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates.

Device Story

System comprises blood glucose meter, test strips, control solutions, lancing device, and lancets. User inserts test strip; applies capillary blood drop. Glucose-reagent reaction generates electrical current proportional to glucose concentration. Meter calculates and displays quantitative concentration (mg/dL or mmol/L). Used at home (single-patient models) or professional healthcare settings (multi-patient models). Data download functionality optional. Healthcare providers use output to monitor diabetes control program effectiveness. Benefits include convenient, rapid glucose monitoring for diabetes management.

Clinical Evidence

Bench testing only. Disinfection efficacy validated using Clorox Bleach Germicidal Wipes (EPA Reg No: 67619-12) against hepatitis B virus. Robustness testing confirmed performance stability after 11,000 cleaning/disinfection cycles. Lay user questionnaire (n=20) confirmed ease of use and labeling clarity.

Technological Characteristics

Amperometric glucose measurement via reagent-coated test strips. Meter calculates concentration based on electrical current. Models 6276-S (single-patient) and 6276-M (multi-patient). Multi-patient models require single-use, auto-disabling lancets. Disinfection validated for 3-year use life. Optional data download capability.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood (finger/forearm) in people with diabetes to monitor control program effectiveness. Contraindicated for neonatal use, diabetes diagnosis, or screening. Multi-patient versions intended for professional healthcare settings using single-use, auto-disabling lancets.

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 Talk Blood Glucose Monitoring System, Model 6277 (K100560)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K133509

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 for the Easy Plus II Blood Glucose Monitoring System 6276-S, Easy Plus II Multi Blood Glucose Monitoring System 6276-M, Smartest Persona II Blood Glucose Monitoring System 6276-S and Smartest Persona II Multi Blood Glucose Monitoring System 6276-M:

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 Talk Blood Glucose Monitoring System, Model 6277 (k100560).

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:

A. Device name change from Easy Talk Blood Glucose Monitoring System, Model 6277 to Easy Plus II Blood Glucose Monitoring System 6276-S, Easy Plus II Multi Blood Glucose Monitoring System 6276-M, Smartest Persona II Blood Glucose Monitoring System 6276-S and Smartest Persona II Multi Blood Glucose Monitoring System 6276-M

B. Removal of speaking function

C. Changes to the meter housing, including colors and shape of buttons

D. The addition of validated cleaning and disinfection instructions to the labeling for multiple patient use

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

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).

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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. Usability studies were conducted to demonstrate that the users could still use the devices with the button modifications. 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.