URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2

K981933 · Medical Analysis Systems, Inc. · JJW · Jun 29, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981933
• Device Name: URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2
• Applicant: Medical Analysis Systems, Inc.
• Product Code: JJW · Clinical Chemistry
• Decision Date: Jun 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

UrichemTRAK Liguid Assayed Control is a human urine based quality control material used in various general chemistry assays. The product is intended for use as a consistent test sample of known concentrations that is assayed along with patient urine specimens when performing urine chemistry assays. The Clinician can compare recovered values over an extended period of time as a means of evaluating analytical precision, as well as reagent and instrument performance.

Device Story

UrichemTRAK Liquid Assayed Control is a human urine-based quality control material; provided in two levels of known concentrations. Used in clinical laboratories to monitor performance of general chemistry assays. Clinicians process control samples alongside patient urine specimens; recovered values compared against expected ranges to assess analytical precision, reagent stability, and instrument performance over time. Serves as a consistent reference material to ensure accuracy and reliability of patient test results.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Human urine-based liquid control material; provided in two levels. Formulated for use in general chemistry assays to monitor analytical precision and instrument performance.

Indications for Use

Indicated for use as a quality control material for human urine-based general chemistry assays to evaluate analytical precision and instrument/reagent performance 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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 9 1998

Scot D. Kinghorn Director, Quality and Regulatory Affairs Medical Analysis Systems, Inc. Lincoln Technology Park 542 Flynn Road Camarillo, California 93012-8058

Re : K981933 Urichem TRAK Liquid Assayed Control, Levels 1 and 2 Regulatory Class: I Product Code: JJW Dated: May 29, 1998 Received: June 2, 1998

Dear Mr. Kinghorn:

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 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 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 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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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your tial equivalence of your device to a legally finding or subbeanstar of results in a classification for your markets product of mits your device to proceed to the market. at 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 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 "[e-mail]".

Sincerely yours,

Steven Autman

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) Notification ● May 29, 1998 UrichemTRAK Liquid Assayed Control Levels 1 and 2

## Statement of Indications for Use

UrichemTRAK Liguid Assayed Control is a human urine based quality control material used in various general chemistry assays. The product is intended for use as a consistent test sample of known concentrations that is assayed along with patient urine specimens when performing urine chemistry assays. The Clinician can compare recovered values over an extended period of time as a means of evaluating analytical precision, as well as reagent and instrument performance.

Prescription Use

Carol C. Benarsh Alfred Montgomery

ivision Sign-Off) Division of Clinica 510(k) Number