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

Intended 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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K093764/

# 510(k) Summary (Per 21 CFR 807.92)

Updated on February 18, 2010

# MAR - 2 2010

#### 1. Submitter Information

| Company name | Biotest Medical Corporation |
|----------------|------------------------------------------------------------------------------------|
| Contact person | Maggie Chu, President |
| Address | No. 3-2, Chien-Kuo Road, TEPZ, Tantzu<br>Taichung 427, Taiwan<br>Republic of China |
| Phone | 886-919099431 |
| Fax | 886-425326593 |

## 2. Name of Device

| Trade Name | SoloV2TM Blood Glucose Monitoring System |
|-----------------|---------------------------------------------------------------------------------------------------------|
| Common Name | Blood Glucose Meter |
| Classifications | NBW, Over the Counter Blood Glucose Test, 862.1345<br>CGA, Glucose Oxidase, 862.1345<br>Class II device |

#### 3. Predicate Device

| Trade name | SuperCheck 1 Blood Glucose Monitoring System (SuperCheck 1). |
|---------------|--------------------------------------------------------------|
| | Model 6268 |
| Common name | Blood Glucose Meter |
| Submitter | Biotest Medical Corporation |
| 510(k) number | K091815 |

#### 4. Device Description

The SoloV2TM Blood Glucose Monitoring System consists of a blood glucose meter, test strips, control solutions, lancing device, and commercially available lancets. The meter has a bilingual speaking feature that provides audible test results for users with low vision. The forearm may be used as an alternate site for capillary blood.

#### 5. Intended 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.

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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.

## 6. Comparison to Predicate Device

Modifications to the cleared device include additional buttons for volume and language adjustment, additional pre-meal and post-meal Logging Flags, substitution of a USB connection for the previous RS232 cable, addition of an insufficient blood error message, and the removal of the test strip ejector mechanism. The size and shape of the device have also been modified to differentiate from the predicate. The SoloV240 Blood Glucose Monitoring System has the same indented use and fundamental scientific technology as the previous version, the SuperCheck 1 Blood Glucose Monitoring System, Model 6268.

## 7. Performance Studies

Biotest Medical Corp. has conducted a risk analysis and has performed the necessary verification and validation activities to demonstrate that the design outputs of the modified device meet the design input requirements.

## 8. Conclusion

In summary, the modified SoloV2TM Blood Glucose Monitoring System has the same intended use and fundamental scientific technology as the previous version of the device, which received 510(k) clearance (K091815). Therefore, the subject device is substantially equivalent to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three stylized wing segments.

Biotest Medical Corp. c/o Maggie Chu No.3-2, Chien-Kuo Road, Tepz, Tantzu Taichung, 427 China (Taiwan)

MAR - 2 2010

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Re: k093764

Trade/Device Name: SoloV2™ Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: January 26, 2010 Received: February 1, 2010

Dear: Ms. Chu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Signature

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): k093764

Device Name: SoloV2TM Blood Glucose Monitoring System

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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use . X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K093764

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