NOVA GLUCOSE CONTROL SOLUTIONS

K033433 · Nova Biomedical Corp. · JJX · Jan 2, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033433
• Device Name: NOVA GLUCOSE CONTROL SOLUTIONS
• Applicant: Nova Biomedical Corp.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jan 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Nova Glucose Control Solution assayed quality control material is used to verify the performance of BD Glucose Monitoring Systems and the BD/Medtronic MiniMed Blood Glucose Monitoring Systems. This control is an OTC product intended for use in the home setting. The Nova Glucose Control Solutions are for in vitro diagnostic use ONLY.

Device Story

Nova Glucose Control Solution is an assayed quality control material used to verify performance of specific blood glucose monitoring systems. Used in home settings by patients or caregivers; provides known glucose concentration to check accuracy/precision of glucose meters and test strips. Output is a verification of system function; helps ensure reliable glucose readings for clinical decision-making. No complex processing; manual application of control solution to test strip.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Assayed aqueous glucose control solution. Formulated to provide specific glucose concentrations for verification of glucose monitoring system performance. Standalone product; no software or electronic components.

Indications for Use

Indicated for use by individuals using BD Glucose Monitoring Systems or BD/Medtronic MiniMed Blood Glucose Monitoring Systems to verify system performance. Intended for OTC home use. In vitro diagnostic use only.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Paul W. MacDonald Chief Ouality Assurance and Regulatory Affairs Officer Nova Biomedical 200 Prospect Street Waltham, MA 02454-9141

Re: k033433

Trade/Device Name: Nova Glucose Control Solution Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: October 27, 2003 Received: October 28, 2003

Dear Mr. 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 http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director 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: | K033433 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Nova Glucose Control Solution |
| Indications For Use: | The Nova Glucose Control Solution assayed quality control material is used to verify the performance of BD Glucose Monitoring Systems and the BD/Medtronic MiniMed Blood Glucose Monitoring Systems. This control is an OTC product intended for use in the home setting. The Nova Glucose Control Solutions are for in vitro diagnostic use ONLY. |

Prescription Use (Part 21 CFR 801 Subpart D)

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AND/OR

11 Over-The-Counter Use (21 CFR 807 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)

Division Sign-Off

1201 Colizer ft ' Office of In Vitro Diagnostic Device Evaluation and Safety

K c.2 7 433

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