ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01

K990317 · Bio-Rad · JJY · Mar 18, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990317
• Device Name: ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01
• Applicant: Bio-Rad
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Liquid Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the anlaytes listed in the value sheet.

Device Story

Abbott Liquid Urine Chemistry Control is an assayed quality control material used in clinical laboratories to monitor the precision of urine chemistry testing procedures. The device consists of a liquid urine matrix containing specific analytes. Laboratory personnel use the control to verify the performance and accuracy of analytical testing systems by comparing observed results against established values provided in the product value sheet. This monitoring process helps ensure the reliability of patient test results and assists in identifying potential analytical errors or instrument drift. The device is intended for professional use in a clinical laboratory environment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid urine-based control material containing specific analytes for quality control of laboratory testing procedures. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for analytes listed in the value sheet in clinical laboratory settings.

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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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of a human figure with outstretched arms, resembling a bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 8 1999

Ms. Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017

Re: K990317

Trade Name: Abbott Liquid Urine Chemistry Control Regulatory Class: I Product Code: JJY Dated: January 26, 1999 Received: January 29, 1999

Dear Ms. Platt:

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 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 regulation (21 CFR Part 820) and that, through periodic OS 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 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_yitro 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.gov/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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X990317 510(k) Number: _ Abbott Liquid Urine Chemistry Control Device Name:

Indications for Use:

Liquid Urine Chemistry Control is intended for use as an assayed quality control urine to monitor the precision of laboratory testing procedures for the anlaytes listed in the value sheet.

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

(Concurrence of CDRH, Office of Device Evaluation)


(Division Sign-Off)
Division of Clinical Laboratory Devices

| 510(k) Number | K990317 |
|---------------|---------|
|---------------|---------|

| Prescription Use | <div>✓</div> | OR | Over-The Counter Use | |
|------------------|--------------|----|----------------------|--|
|------------------|--------------|----|----------------------|--|

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