SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM

K093764 · Biotest Medical Corp. · NBW · Mar 2, 2010 · Clinical Chemistry

Device Facts

• Record ID: K093764
• Device Name: SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Biotest Medical Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 2, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The SoloV2TM Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the forearm. It is intended for use by healthcare professionals and people with diabetes mellitus at home and as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis or screening for diabetes mellitus, nor for use with neonates. The alternative site testing (forearm) in this system can only be used during steady-state blood glucose conditions. This system contains a speaking function that provides audible test results for users with low vision.

Device Story

SoloV2 Blood Glucose Monitoring System measures glucose in capillary whole blood; utilizes test strips and meter; provides quantitative results. Features bilingual speaking function for low-vision users; includes pre-meal/post-meal logging flags; USB connectivity. Used by healthcare professionals or patients at home for diabetes management. Input: capillary blood sample on test strip. Output: visual and audible glucose concentration readings. Assists in monitoring diabetes control program effectiveness. Modifications from predicate include volume/language buttons, USB port, insufficient blood error message, and removal of strip ejector.

Clinical Evidence

Bench testing only; no clinical data provided. Verification and validation activities performed per design control procedures to assess impact of modifications.

Technological Characteristics

Glucose oxidase-based electrochemical blood glucose meter. Features USB connectivity, audible output for low vision, and logging flags. Powered by battery. Form factor modified from predicate. No specific material standards or software architecture details provided.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from finger or forearm in patients with diabetes mellitus. Not for neonates. Forearm testing restricted to steady-state glucose conditions. Includes audible results for low-vision users.

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

To: THE FILE
RE: DOCUMENT NUMBER k093764

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary) for the SOLOV2 Blood Glucose Monitoring System:

1. The name and 510(k) number of Biotest Medical Corp.'s previously cleared device, SuperCheck 1, Blood Glucose Monitoring System, Model 6268 cleared under k091815. (For a preamendments device, a statement to this effect has been provided.)
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 outer case dimension and shape, user interface functions such as addition of Up/Down speaker volume control, language button, pre / post meal logging flags, and insufficient blood error message. Plus the removal of strip ejector function, and changed data transmission port from RS232 to mini-USB.

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

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.