EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277

K100560 · Biotest Medical Corp. · NBW · May 12, 2010 · Clinical Chemistry

Device Facts

• Record ID: K100560
• Device Name: EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277
• Applicant: Biotest Medical Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: May 12, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SuperCheck 1 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger, palm, and forearm. It is intended for use by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Device Story

Easy Talk Blood Glucose Monitoring System measures glucose in capillary whole blood samples via test strips. System includes meter, test strips, control solutions, lancing device, and lancets. Meter features bilingual speaking function for audible results, aiding users with low vision. Used by healthcare professionals or patients at home for monitoring diabetes control programs. Forearm testing permitted only during steady-state glucose conditions. Device provides quantitative glucose concentration output. Modifications from predicate include added backlight, changed error message (E7 to E4), and updated physical form factor.

Clinical Evidence

Clinical performance study conducted to validate usability and accuracy for consumer use. Results demonstrated substantial equivalence to predicate device.

Technological Characteristics

Glucose oxidase-based electrochemical test system. Includes meter with backlight and bilingual audio output for low vision users. Capillary blood sampling from finger or forearm. Standalone device.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from finger, palm, and forearm; intended for home use by individuals with diabetes to monitor glycemic control; not for diabetes diagnosis/screening; not for neonates.

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

• SuperCheck 1 Blood Glucose Monitoring System, Model 6268 (k091815)

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 k100560

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:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (k091815 - SuperCheck 1 Blood Glucose Monitoring System, Model 6268).
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.
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:

Addition of back light feature, error message change, and modification of outer case dimensions.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and sample type. Studies include software validation, data transmission test, talking feature test, system accuracy test, mechanical resistance to drop and vibration, evaluation of the effects of temperature and humidity, and user study evaluation.
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.