CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1, MODEL AP11001, LEVEL 2, MODEL AP22002

K980514 · Medical Analysis Systems, Inc. · JJY · Mar 4, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980514
• Device Name: CHEMTRAK PLATINUM COMPREHENSIVE LIQUID ASSAYED CHEMISTRY AND TDM CONTROL LEVEL 1, MODEL AP11001, LEVEL 2, MODEL AP22002
• Applicant: Medical Analysis Systems, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

chemTRAK® Platinum Comprehensive Liquid Assayed Chemistry and TDM Control is a bovine based quality control material for use as a consistent test sample of known concentrations that is assayed along with patient serum specimens when assaying for any of the listed constituents. The material is used in various general chemistry and TDM procedures to monitor analytical precision, as well as reagent and instrument performance.

Device Story

chemTRAK® Platinum Comprehensive Liquid Assayed Chemistry and TDM Control is a bovine-based quality control material. It serves as a consistent test sample with known concentrations of specific constituents. Clinical laboratory personnel use the product alongside patient serum specimens during general chemistry and TDM assays. By comparing recovered values against known concentrations, the device allows for the monitoring of analytical precision, reagent stability, and instrument performance. It is intended for use in clinical laboratory settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bovine-based liquid control material; provided in three levels (1, 2, and 3) with known concentrations of chemistry and TDM constituents.

Indications for Use

Indicated for use as a quality control material in clinical laboratories to monitor analytical precision and performance of reagents and instruments during general chemistry and therapeutic drug monitoring (TDM) testing of patient serum specimens.

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

MAR - 4 1998

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

Re : K980514 chem®TRAK Platimum Comprehensive Liquid Assayed Chemistry and TDM Control, Levels 1, 2, and 3 Regulatory Class: I Product Code: JJY February 9, 1998 Dated: Received: February 10, 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 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 General regulation (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 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

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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 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 "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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Analysis Systems, Inc 542 Flynn Road · Camarillo, CA 93012-8058 echnology Park . [phone] · FAX: [phone]

## MEDICAL ANALYSIS SYSTEMS, INC.

510(k) Notification · February 9, 1998 510(K) Notifcation > February 9, 1996
chemTRAK® Platinum Comprehensive Liquid Assayed Chemistry and TDM Control Levels 1, 2 and 3

## Statement of Indications for Use

chemTRAK® Platinum Comprehensive Liquid Assayed Chemistry and TDM Chem I RAR "Haman Oompronomaterial used in various general chemistry

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(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K9805151