MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3

K023867 · Medical Analysis Systems, Inc. · JJY · Dec 17, 2002 · Clinical Chemistry

Device Facts

• Record ID: K023867
• Device Name: MAS T-MARKER, LEVEL 1,2 AND 3, DADE SPECIAL-T MARKER, LEVEL 1,2 AND 3
• Applicant: Medical Analysis Systems, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Dec 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

MAS® T-Marker Control is intended for use in the clinical laboratory as a quantitative. control for monitoring test procedures used to assay human serum for tumor markers. Include T-Marker Control with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument. DADE® Special-T Marker® Control is intended for use in the clinical laboratory as a quantitative control for monitoring test procedures used to assay human serum for tumor markers. Include Special-T Marker® Control with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

Device Story

MAS® T-Marker and DADE® Special-T Marker® are quality control materials used in clinical laboratories. These controls are processed alongside patient serum specimens during tumor marker assays. By comparing observed assay values against provided expected ranges, laboratory personnel monitor the consistency and accuracy of reagent and instrument performance. The device serves as a standard reference to validate the reliability of clinical testing procedures for tumor markers.

Clinical Evidence

No clinical data; bench testing only. The device is a quality control material intended for monitoring assay performance, not for diagnostic use on patients.

Technological Characteristics

Quality control material for tumor marker assays. Formulated for use in clinical laboratory systems. Provides assayed values for specific instrument platforms to verify performance consistency.

Indications for Use

Indicated for use in clinical laboratories as a quantitative control for monitoring human serum tumor marker assay procedures. Intended for professional use to ensure consistent performance of reagents and instruments.

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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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Penny M. Layman Manager, Regulatory Affairs Medical Analysis Systems, Inc. 5300 Adolfo Road Camarillo, CA 93012

k023867 Re: Trade/Device Name: MAS® T-Marker, Level 1, 2 and 3 DADE ® Special-T Marker®, Level 1, 2 and 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) . Regulatory Class: Class I Product Code: JJY Dated: November 15. 2002 Received: November 20, 2002

Dear Ms. Layman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA s issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE FORM

510(k) Number (if known): 40 43 86 MAS® T-Marker , Level 1, 2 and 3 Device Name: DADE® Special-T Marker®, Level 1, 2 and 3

Indications for Use:

MAS® T-Marker Control is intended for use in the clinical laboratory as a quantitative. control for monitoring test procedures used to assay human serum for tumor markers. Include T-Marker Control with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

DADE® Special-T Marker® Control is intended for use in the clinical laboratory as a quantitative control for monitoring test procedures used to assay human serum for tumor markers. Include Special-T Marker® Control with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

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Concurence of CDRH, Office of Device Evaulation (ODE)

- Prescription use

Hluero for J. Bautista

(Division Sign-Off) Division of Clinical Laboratory Devices 112 356 1 510(k) Number

(Optional Format 3-10-98)