GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM

K123517 · Sd Biosensor · NBW · Jan 17, 2014 · Clinical Chemistry

Device Facts

• Record ID: K123517
• Device Name: GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Sd Biosensor
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 17, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The SD GlucoMentor multi Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from fingertip, palm, upper arm, or forearm. The SD GlucoMentor multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The SD GlucoMentor multi Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes, or for neonatal use. Alternative site testing should be done only during steady state times (when glucose is not changing rapidly). The SD GlucoMentor multi Blood Glucose Test Strips are for use with the SD GlucoMentor multi Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.

Device Story

SD GlucoMentor is a portable, battery-operated blood glucose monitoring system. It utilizes test strips containing glucose oxidase and mediators to react with a capillary blood sample, generating an electric current proportional to glucose concentration. The meter measures this current and displays the result in mg/dL. The device stores 500 test results, including 7, 14, and 30-day averages for normal, pre-meal, and post-meal states. It features user-settable alarms for hypo-warning and meal-related events. Used by professional healthcare personnel (multi-patient) or diabetics at home (single-patient) to aid in diabetes management. Healthcare providers use the displayed results to assess the effectiveness of a patient's diabetes control program. The system includes a check strip for meter verification and a control solution for system validation.

Clinical Evidence

No clinical sensitivity or specificity testing performed. System accuracy evaluated via method comparison with predicate device per ISO 15197:2003. User performance study conducted with lay consumers using capillary blood from fingertip, palm, forearm, and upper arm to demonstrate accurate results.

Technological Characteristics

Portable, battery-operated electrochemical glucose meter. Uses glucose oxidase-based test strips. Features include 500-result memory, multi-day averaging, and alarm settings. Complies with ISO 15197:2003, IEC 61010-1, and IEC 61010-2. Connectivity includes codechip interface. Sterilization not specified.

Indications for Use

Indicated for quantitative blood glucose measurement in patients with diabetes to monitor control effectiveness. For use with fresh capillary whole blood from fingertip, palm, upper arm, or forearm. Contraindicated for neonatal use, diabetes diagnosis, or screening. 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

• SmartLink™ Gold (K100398)

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 K123517

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.) The predicate device SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM was cleared under k100398.

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. Modifications of Printed Circuit Board (PCB), including changes to the PCB dimension, material and net pattern's length and shape
b. Inner capillary space of the test strip (SD GlucoMentor) was modified.
c. Increase of memory capacity from 400 test results to 500 test results.
d. Change of icons locations, and addition of 3 more digits on the date display icon.
e. Modification of meter appearance (size, weight and color).
f. New brand name printed on the test strip.
g. Modification of check strip (different electrode space dimension).

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and comparison analysis. Studies performed include sample volume study, software validation, electric and magnetic safety, precision, linearity, accuracy and lay user studies. Additionally, the sponsor performed disinfection and robustness testing on the proposed device.

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.

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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.