SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM

K122525 · Biotest Medical Corp. · NBW · May 2, 2013 · Clinical Chemistry

Device Facts

• Record ID: K122525
• Device Name: SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Biotest Medical Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: May 2, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Smartest™ Glucowise Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus.

Device Story

System comprises blood glucose meter, test strips, control solutions, lancing device, and lancets. User inserts test strip; applies capillary blood drop. Glucose reacts with reagents on strip; generates electrical current proportional to glucose concentration. Meter calculates and displays quantitative glucose concentration (mg/dL or mmol/L). Used by patients at home or healthcare professionals in clinical settings. Data download functionality optional. Modification from predicate (K091815) involves removal of voice/talking feature. Benefits include monitoring diabetes control effectiveness.

Clinical Evidence

Bench testing only. Verification and validation activities were conducted to demonstrate that design outputs of the modified device meet design input requirements.

Technological Characteristics

In vitro diagnostic glucose test system using electrochemical sensing (glucose oxidase). System includes meter, test strips, and control solutions. Modification involved removal of speaker and talking software module. Sterilization, shelf-life, and biocompatibility remain equivalent to predicate.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood (fingertip/forearm) as an aid to monitor diabetes control. Intended for home self-testing (Model 6267-S) or professional multi-patient use (Model 6267-M). Contraindicated for diabetes diagnosis, screening, or neonatal use. Alternative site testing restricted to steady-state glucose conditions.

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 (k091815)

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 k122525

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 Smartest Glucowise Blood Glucose Monitoring System, Model 6267-S and Smartest Glucowise MULTI Blood Glucose Monitoring System, Model 6267-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.) SuperCheck 1 Blood Glucose Monitoring System (k091815).

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 SuperCheck 1 Blood Glucose Monitoring System to Smartest™ Glucowise Blood Glucose Monitoring System Model 6267-S and Smartest™ Glucowise MULTI Blood Glucose Monitoring System Model 6267-M
B. Removal of speaking function

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. 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.

Smartest Glucowise Blood Glucose Monitoring System Model 6267-S is intended for single-patient use, and Smartest Glucowise MULTI Blood Glucose Monitoring System Model 6267-M for multiple patient use/healthcare professional use. Efficacy of the COLORX Bleach Germicidal Wipes (with EPA registration# 67619-12) was validated using hepatitis B surface antigen testing and materials from the meter and lancing device (for use with the single-patient use system only).

The sponsor also performed robustness studies demonstrating that there was no change in performance or in the materials of the meters and lancing device after 11,000 cleaning and disinfection cycles designed to simulate 3 year use life of the devices. Adequate instructions for the validated cleaning and disinfection procedures have been reflected in the labeling of the devices.