UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30

K973931 · Diagnostic Chemicals , Ltd. · CDQ · Nov 24, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973931
• Device Name: UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: CDQ · Clinical Chemistry
• Decision Date: Nov 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1770
• Device Class: Class 2

Intended Use

For the quantitative determination of urea in serum. For IN VITRO diagnostic use. The measurement of urea can be clinically useful in the diagnosis of kidney disfinction. Serum urea plays an important role in the discrimination between prerenal and postrenal azotemia.

Device Story

Urea-SL Assay is an in vitro diagnostic reagent for quantitative urea measurement in serum samples. Used in clinical laboratory settings by trained personnel. Principle of operation involves chemical reaction to measure urea levels; results assist clinicians in diagnosing kidney dysfunction and differentiating between prerenal and postrenal azotemia. Output is a quantitative urea concentration value used to inform clinical decision-making regarding renal health.

Clinical Evidence

No clinical data provided; device is an in vitro diagnostic reagent evaluated via bench testing and substantial equivalence comparison.

Technological Characteristics

In vitro diagnostic chemical assay for serum urea quantification. Reagent-based chemistry system. No software, electronics, or mechanical components.

Indications for Use

Indicated for quantitative determination of urea in serum for patients requiring assessment of kidney function and discrimination between prerenal and postrenal azotemia.

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)

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Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three overlapping human profiles facing to the right.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Karen Callbeck, R.T.B.Sc. .Requlatory Affairs Coordinator Diagnostic Chemicals Limited West Royalty Industrial Park Charolettetown, PE Canada C1E, 1B0

NOV 2 4 1997

Re : K973931 Urea-SL Assay Requlatory Class: II Product Code: CDQ Dated: October 1, 1997 Received: October 15, 1997

Dear Ms. Callbeck:

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. 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory In addition, FDA may publish further announcements action. 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.

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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 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, "Misbranding by reference to 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/dsmamain.html".

Sincerely yours,
Steven Sitman

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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510(k) Number (if known): K973931

Device Name: Urea-SL Assay

Indications For Use:

117/87

For the quantitative determination of urea in serum. For IN VITRO diagnostic use.

The measurement of urea can be clinically useful in the diagnosis of kidney disfinction. Serum urea plays an important role in the discrimination between prerenal and postrenal azotemia.

1. Tietz, N.W., Textbook of Clinical Chemistry, W.B. Saunders Co. 1286, 1986.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Number 6973931

Prescription Use
(Per 21 CFR 801.109)

and the same a subscription of the collection in

OR

Over-The-Counter Use .

(Optional Format 1-2-96)