SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268

K091815 · Biotest Medical Corp. · NBW · Nov 16, 2009 · Clinical Chemistry

Device Facts

• Record ID: K091815
• Device Name: SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268
• Applicant: Biotest Medical Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SuperCheck 1 Blood Glucose Monitoring System, Model 6268, 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. The SuperCheck 1 Blood Glucose Monitoring System is not intended for the diagnosis of 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

System measures glucose in capillary whole blood via glucose oxidase amperometry; requires 0.7 uL sample; 6-second reaction time. Meter includes speaking function for visually impaired users; RS232 port for data transfer. Used by patients at home or healthcare professionals in clinical settings. Input: blood sample on test strip; Output: quantitative glucose concentration displayed on LCD and provided via audible voice output. Benefits: enables self-monitoring of blood glucose levels for diabetes management. Device uses thermistor for automatic temperature compensation. No coding required; meter and strip reference numbers must match.

Clinical Evidence

Performance evaluated via laboratory and clinical studies involving both healthcare professionals and lay users. Studies confirmed system performance meets intended use criteria. No specific sensitivity/specificity metrics provided in summary.

Technological Characteristics

Electrochemical glucose monitoring system. Includes speaking function for audible results. Supports alternate site testing (forearm).

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from finger or forearm in patients with diabetes mellitus. Intended for use by healthcare professionals and patients at home. Contraindicated for neonates and for diagnosis or screening of diabetes. Forearm 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

• Prodigy Voice Blood Glucose Monitoring System (k073118)

Submission Summary (Full Text)

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K091815

# 510(k) Summary

## NOV 1 6 2009

#### Submitter Information 1.

| Company name | Biotest Medical Corporation |
|----------------|--------------------------------------|
| Contact person | Maggie Chu, President |
| Address | No. 3-2, Chien-kuo Road, TEPZ Tantzu |
| | Taichung 427, Taiwan |
| | Republic of China |
| Phone | 866 4-2532-6668 |
| Fax | 866 4-2532-6593 |

#### 2. Name of Device

| Trade Name | SuperCheck 1 Blood Glucose Monitoring System, Model 6268 |
|-----------------|---------------------------------------------------------------------------------------------------------|
| Common Names | Blood Glucose Meter<br>Blood Glucose Test Strips |
| Classifications | NBW, Over the Counter Blood Glucose Test, 862.1345<br>CGA, Glucose Oxidase, 862.1345<br>Class II device |

#### Predicate Device 3.

Prodigy Voice Blood Glucose Monitoring System Trade/Proprietary Common/Usual NameBlood Glucose Meter

| | Blood Glucose Test Strips |
|---------------|---------------------------|
| Submitter | Diagnostic Devices Inc. |
| 510(k) Number | K073118 |

#### Device Description 4.

The SuperCheck 1 Blood Glucose Monitoring System, Model 6268 consists of a blood glucose meter, blood glucose test strips, control solutions, the lancing device, and lancets. The meter also comes with a speaking function that provides audible test results for users with low vision. The SuperCheck 1 Model 6268 allows the forearm to be used as an alternate site. User performance testing was conducted to support an over-the-counter indication.

#### Intended Use 5.

The SuperCheck 1 Blood Glucose Monitoring System, Model 6268, 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. The SuperCheck 1 Blood Glucose Monitoring System is not intended for the diagnosis of 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.

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This system contains a speaking function that provides audible test results for users with low vision.

#### Comparison to Predicate Device 6.

The SuperCheck 1 Blood Glucose Monitoring System, Model 6268, has equivalent technological characteristics and intended use as the Prodigy Voice Blood Glucose Monitoring System; however, the SuperCheck 1 has one alternate site at this time, the forearm.

#### 7. Performance Studies

The performance of the SuperCheck 1 Blood Glucose Monitoring System, Model 6268 was studied in the laboratory and in clinical settings by healthcare professionals and lay users. The studies demonstrated that the performance of the SuperCheck 1 system meets its intended use.

#### Conclusion 8.

The SuperCheck 1 Blood Glucose Monitoring System, Model 6268 demonstrates satisfactory performance, is suitable for its intended use, and is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's name around the perimeter. Inside the circle is an abstract image of an eagle.

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

NOV 1 6 2009

Biotest Medical Corporation c/o Diane Mandell Horwitz, Ph.D., RAC Mandell Horwitz Consultants, LLC 2995 Steven Martin Dr., Fairfax, VA 22031

Re: k091815 SuperCheck 1 Blood Glucose Monitoring System Trade/Device Name: Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: October 29, 2009 Received: November 2, 2009

Dear Ms. Mandell Horwitz

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 I carrest surfields and regarding but not limited to: registration and listing (21 CFR Part 807); labeling (21 Act of equirements, and good manufacturing practice requirements as set forth in the quality systems {OS} regulation (21 CFR Part 820).

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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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/ResourcesforYou/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 Form

510(k) Number: K091815

Device Name: SuperCheck 1, Model 6268

Indications for Use:

The SuperCheck 1 Blood Glucose Monitoring System, Model 6268, 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 of 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 IF NEEDED)

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

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Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K091815

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