CHOLESTECH BUN/CREATININE TEST SYSTEM

K972012 · Cholestech Corp. · CDN · Jul 24, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972012
• Device Name: CHOLESTECH BUN/CREATININE TEST SYSTEM
• Applicant: Cholestech Corp.
• Product Code: CDN · Clinical Chemistry
• Decision Date: Jul 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1770
• Device Class: Class 2

Intended Use

For the quantitative determination of Blood Urea Nitrogen and creatinine in whole blood. Creatinine values are used as indications of renal function. Blood Urea Nitrogen values are valuable in the diagnosis of renal disorders. For professional in vitro diagnostic use only.

Device Story

Cholestech BUN/Creatinine Test System II performs quantitative analysis of BUN and creatinine in whole blood samples. Device intended for professional in vitro diagnostic use. System provides diagnostic information regarding renal function and disorders. Healthcare providers use output to assess patient kidney health and guide clinical decision-making.

Technological Characteristics

In vitro diagnostic test system for quantitative measurement of BUN and creatinine in whole blood. Professional use device.

Indications for Use

Indicated for professional in vitro diagnostic use for the quantitative determination of Blood Urea Nitrogen (BUN) and creatinine in whole blood to assist in the diagnosis of renal disorders and assessment of renal function.

Regulatory Classification

Identification

A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is black and white.

- -

JUL 2 4 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Gary Hewett Cholestech Corporation 3347 Investment Boulevard Havward, California 94545-3808

K972012 Re : Cholestech BUN/Creatinine Test System II Requlatory Class: Product Code: CDN, JFY Dated: May 28, 1997 Received: May 30, 1997

Dear Mr. Hewett:

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 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. ਬੈ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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.

{1}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 qeneral 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/dsmamain.html".

Sincerely yours,
Steven Ditman

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

{2}------------------------------------------------

Page_of_of_l

10(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ evice Name: ( Chatestech; LOX ( BUN / Chestimise Panel

dications For-Use: .. . . . . . . . .

For the evantitative determination of Blood uven Nitrogen and crestining in while bloog). Creekinne values are used as inclications of renal function . Blood Unen Nitrogen values are valuable in the blaginosis of remal disocrees. For protessional in Urlus diagnostic ise only.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K972012 |

Prescription Use V OR Over-The-Counter Use_

(Per 21 CFR 801.109) (Optional Format 1-2-96)