NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

K063821 · Nova Biomedical Corp. · CGA · Jan 24, 2007 · Clinical Chemistry

Device Facts

• Record ID: K063821
• Device Name: NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Applicant: Nova Biomedical Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jan 24, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Nova StatStrip Glucose Hospital Meter is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous, arterial, and neonate whole blood. It is indicated for use in a clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control. Nova StatStrip Glucose Test Strips are intended for use only with the StatStrip Glucose Hospital Meter for quantitative tests. The glucose meter is intended to quantitatively measure glucose (sugar) in whole blood. The Glucose Meter is calibrated to provide plasma equivalent results to laboratory methods. Nova StatStrip Glucose Test Strips are for testing outside the body (in vitro diagnostic use only). Nova StatStrip Control Solutions is intended for use with the Nova StatStrip Glucose Hospital Meter and Nova StatStrip Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. There are three levels of controls, (Level 1, Level 2, and Level 3). These solutions will be offered for sale separately from the meter. Nova StatStrip Glucose Linearity Kit solutions are used to check the linearity of the Nova StatStrip Glucose Hospital Meter System. There are five levels of linearity solutions, (Level 1, Level 2, Level 3, Level 4, and Level 5).

Device Story

Nova StatStrip Glucose Hospital Meter System is a point-of-care diagnostic device for quantitative glucose measurement in whole blood (capillary, venous, arterial, neonate). Operated by healthcare professionals in clinical settings; provides plasma-equivalent glucose results to aid diabetes management. System includes meter, test strips, control solutions, and linearity kits. Meter performs electrochemical analysis of blood samples applied to test strips; results displayed to clinician for immediate clinical decision-making. Benefits include rapid, accurate bedside glucose monitoring, reducing need for central laboratory testing.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on bench testing and performance verification of the glucose measurement system.

Technological Characteristics

Electrochemical glucose measurement system; handheld meter form factor; utilizes disposable test strips; includes liquid control solutions and linearity kits for quality assurance; calibrated for plasma-equivalent results.

Indications for Use

Indicated for quantitative glucose measurement in capillary, venous, arterial, and neonate whole blood by healthcare professionals in clinical settings to monitor diabetes control effectiveness.

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.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Paul W. MacDonald, Ph.D. Nova Biomedical Corp. 200 Prospect Street Waltham, MA 02454-9141

JAN 2 4 2007

Re: k063821 Trade/Device Name: Nova StatStrip Glucose Hospital Meter System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system. Regulatory Class: Class II Product Codes: CGA, JJX Dated: December 20, 2006 Received: December 26, 2006

Dear Dr. MacDonald:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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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.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97). 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 [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Coopes, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. 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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## 4. Indications for Use

Indications for Use

K063821

510(k) Number:

Device Name:

Nova StatStrip Glucose Hospital Meter System

Indications for Use:

The Nova StatStrip Glucose Hospital Meter System is intended for in vitro diagnostic use by health care professionals and for Point-Of-Care usage for the quantitative measurement of glucose in capillary, venous, arterial, and neonate whole blood. It is indicated for use in a clinical setting by healthcare professionals as an aid to monitor the effectiveness of diabetes control.

Nova StatStrip Glucose Test Strips are intended for use only with the StatStrip Glucose Hospital Meter for quantitative tests. The glucose meter is intended to quantitatively measure glucose (sugar) in whole blood. The Glucose Meter is calibrated to provide plasma equivalent results to laboratory methods. Nova StatStrip Glucose Test Strips are for testing outside the body (in vitro diagnostic use only).

Nova StatStrip Control Solutions is intended for use with the Nova StatStrip Glucose Hospital Meter and Nova StatStrip Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. There are three levels of controls, (Level 2, and Level 3). These solutions will be offered for sale separately from the meter.

Nova StatStrip Glucose Linearity Kit solutions are used to check the linearity of the Nova StatStrip Glucose Hospital Meter System. There are five levels of linearity solutions. (Level 2, Level 3. Level 4. and Level 5).

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

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Carol C. Benson

Tos of In Vitro Diagnostic Device Juation and Safety

K 06871