DUAL VIAL CREATININE REAGENT

K983937 · Intersect Systems, Inc. · CGX · Jan 6, 1999 · Clinical Chemistry

Device Facts

• Record ID: K983937
• Device Name: DUAL VIAL CREATININE REAGENT
• Applicant: Intersect Systems, Inc.
• Product Code: CGX · Clinical Chemistry
• Decision Date: Jan 6, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

A creatinine test system is an in vitro device intended to measure creatinine quantitatively in serum, plasma or urine. Creatinine measurements are used in the diagnosis and treatment of certain renal functions.

Device Story

Dual Vial Creatinine Reagent is an in vitro diagnostic reagent used to measure creatinine levels in serum, plasma, or urine samples. The device functions as a chemical test system for clinical laboratory use. By quantifying creatinine concentrations, the reagent assists clinicians in assessing renal function and diagnosing kidney-related conditions. The output is a quantitative measurement provided to healthcare professionals to inform clinical decision-making regarding patient renal health.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the device's intended use and technological characteristics as a standard creatinine test system.

Technological Characteristics

In vitro diagnostic reagent for quantitative creatinine measurement. Operates via chemical analysis of serum, plasma, or urine. Classified as a Creatinine Test System under 21 CFR 862.1345.

Indications for Use

Indicated for the quantitative measurement of creatinine in serum, plasma, or urine to aid in the diagnosis and treatment of renal diseases. For prescription use.

Regulatory Classification

Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Submission Summary (Full Text)

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## 6 1999 JAN

Mark E. Legaz, Ph.D., DABCC President Intersect Systems, Inc. 1152 3rd Avenue, Suite D/E P.O. Box 2219 Lonqview, Washington 98632

Re: K983937 Dual Vial Creatinine Reagent Trade Name: Requlatory Class: II Product Code: CGX Dated: October 29, 1998 November 5, 1998 Received:

Dear Dr. Legaz:

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 misbranding 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 Requlations, 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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 requlations.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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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 leqally 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 requlation (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, "Misbrandinq 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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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

Enclosure

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## Indication for Use

Trade Name of the Device: Dual Vial Creatinine Reagent

510(k) Number: K983937

Classification Name; Number: Creatinine Test System; 21 CFR §862.1345

Indications for Use

- A creatinine test system is an in vitro device intended to measure creatinine quantitatively in * serum, plasma or urine. Creatinine measurements are used in the diagnosis and treatment of certain renal functions.
Sean Cooper 1/4/99
(Division Sign-Off)

Division of Clinical boratory Devices 510(k) Number

Prescription Use ✓