QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2

K993631 · Seracare Technology · JJY · Dec 9, 1999 · Clinical Chemistry

Device Facts

• Record ID: K993631
• Device Name: QUALITROL TUMOR MARKER CONTROL, LEVELS 1 AND 2
• Applicant: Seracare Technology
• Product Code: JJY · Clinical Chemistry
• Decision Date: Dec 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

QUALITROL TUMOR MARKER CONTROL, Levels 1 and 2, is a lyophilized human serum based assayed quality control material intended to monitor the naman of clinical immunological test procedures that analyze for tumor associated antigens.

Device Story

Qualitrol Tumor Marker Control (Levels 1 and 2) is a lyophilized, human serum-based quality control material. It is used in clinical laboratories to monitor the performance and accuracy of immunological test procedures designed to detect tumor-associated antigens. By providing a known reference value, the control allows laboratory personnel to verify that assay systems are functioning correctly, ensuring the reliability of patient test results. It does not perform diagnostic analysis itself but serves as a standard for quality assurance in clinical testing workflows.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lyophilized human serum-based control material. Formulated for use as an assayed quality control for tumor marker immunological assays.

Indications for Use

Indicated for use as an assayed quality control material to monitor the performance of clinical immunological test procedures analyzing tumor-associated antigens in human serum. No specific patient population or contraindications provided.

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

DEC - 9 1999

Mr. Rusty Sewell Product Development Engineer SeraCare Technology, Inc. 2170 Woodward Street Austin, Texas 78744-1832

K993631 Re: Trade Name: Qualitrol Tumor Marker Control, Levels 1 and 2 Regulatory Class: I Product Code: JJY Dated: October 29, 1999 Received: October 27, 1999

Dear Mr. Sewell:

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 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 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 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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

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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## INDICATIONS FOR USE STATEMENT

510(k) number (if known): K 993621

Device name:

QUALITROL TUMOR MARKER CONTROL, Levels 1 and 2

Indications for use:

QUALITROL TUMOR MARKER CONTROL, Levels 1 and 2, is a lyophilized human serum based assayed quality control material intended to monitor the naman of clinical immunological test procedures that analyze for tumor associated antigens.

Peter G. Maken