SUPREME II CONTROL SOLUTIONS

K983432 · Chronimed, Inc. · JJX · Dec 17, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983432
• Device Name: SUPREME II CONTROL SOLUTIONS
• Applicant: Chronimed, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Dec 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The intended use of the Supreme II Control Solutions is to verify the performance of the Supreme II Blood Glucose Test System using solutions with a known amount of glucose The solutions are intended for in-vitro use only.

Device Story

Supreme II Control Solutions serve as quality control reagents for the Supreme II Blood Glucose Test System. Solutions contain known glucose concentrations; used by patients or clinicians to verify system accuracy and performance. Operation involves applying control solution to test strips; comparing resulting meter reading against expected range provided by manufacturer. Confirms proper function of test strips and meter; ensures reliable blood glucose monitoring for diabetic patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In-vitro diagnostic control solution containing known glucose concentrations. Designed for use with the Supreme II Blood Glucose Test System. No complex software, electronics, or specialized materials described.

Indications for Use

Indicated for use as an in-vitro diagnostic control to verify the performance of the Supreme II Blood Glucose Test System by providing solutions with a known glucose concentration.

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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DEC 17 1998

Mr. Jeffrey P. Heaton Manager, Quality Assurance and Requlatory Affairs Chronimed. Inc. 10900 Red Circle Drive Minnetonka, Minnesota 55343

K983432 Re: Supreme II Control Solutions Trade Name: Requlatory Class: I Product Code: JJX Dated: September 25, 1998 Received: September 29, 1998

Dear Mr. Heaton:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 misbrandinq and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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## Paqe 2

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance, at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K983432
510(k) Number (if known): unknown

Device Name: Supreme II Control Solutions

Indications for Use:

The intended use of the Supreme II Control Solutions is to verify the performance of the Supreme II Blood Glucose Test System using solutions with a known amount of glucose

The solutions are intended for in-vitro use only.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Device
510(k) Number K983432

Over-the-Counter Use

Prescription Use (Per 21 CFR 801.109) OR

(Optional Format 1-2-96)