UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)

K971477 · Trace America, Inc. · CDQ · May 27, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971477
• Device Name: UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)
• Applicant: Trace America, Inc.
• Product Code: CDQ · Clinical Chemistry
• Decision Date: May 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1770
• Device Class: Class 2

Intended Use

Intended for the In Vitro, quantitative determination of Urea Nitrogen) in human serum and urine for clinical diagnosis. "This Urea (Urea Nitrogen) test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases." CFR 862.1770

Device Story

TRACE Urea (Urea Nitrogen) - DST Reagent is an in vitro diagnostic test system. It measures urea nitrogen, an end-product of nitrogen metabolism, in human serum, plasma, and urine samples. The device is used in clinical laboratory settings to assist healthcare providers in diagnosing and monitoring renal and metabolic conditions. Results are provided to clinicians to inform clinical decision-making regarding patient treatment and disease management.

Clinical Evidence

No clinical data provided; device is an in vitro diagnostic reagent system.

Technological Characteristics

In vitro diagnostic reagent system for quantitative determination of urea nitrogen. Operates via chemical analysis of serum, plasma, or urine samples. Class I device per 21 CFR 862.1770.

Indications for Use

Indicated for the quantitative determination of urea nitrogen in human serum, plasma, and urine to aid in the diagnosis and treatment of renal and metabolic diseases.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 27 1997

David Johnston · Technical Director TRACE America, Inc. 7260 North West 58th Street Miami, Florida 33166

Re : K971477 Urea Nitrogen Requlatory Class: I Product Code: CDO Dated: April 7, 1997 Received: April 23, 1997

Dear Mr. Johnston:

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 The general controls provisions of the Act 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 regulations.

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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 deyice 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 diaqnostic 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 Gutman

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): | (to be assigned) |
|---------------------------|------------------------------------------|
| Device Name: | TRACE Urea (Urea Nitrogen) - DST Reagent |

Indications for Use:

Intended for the In Vitro, quantitative determination of Urea Nitrogen) in human serum and urine for clinical diagnosis.

"This Urea (Urea Nitrogen) test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases." CFR 862.1770

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Concurrence of CDRH, Office of Device Evaluation (QDE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Numiber 971447

Prescription Use _ (Per 21 CFR 801.109) OR

Over-The-Counter Use _

(Optional Format 1-2-96)