LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580

K983807 · Bio-Rad · JJY · Dec 16, 1998 · Clinical Chemistry

Device Facts

• Record ID: K983807
• Device Name: LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580
• Applicant: Bio-Rad
• Product Code: JJY · Clinical Chemistry
• Decision Date: Dec 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Lyphochek Tumor Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Device Story

Lyphochek Tumor Marker Control is an in vitro diagnostic quality control product used by clinical laboratory professionals. It consists of human serum supplemented with human-derived constituents and pure chemicals, processed into a lyophilized form to enhance stability. The device serves as a reference material to monitor the precision and accuracy of laboratory testing procedures for various tumor marker analytes. By analyzing this control alongside patient samples, laboratory personnel can verify the performance of their testing systems and ensure the reliability of clinical results. It is intended for prescription use in professional laboratory environments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lyophilized human serum base with added human-derived constituents and pure chemicals. Formulated for stability as an assayed quality control material for tumor marker testing.

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for specific tumor marker analytes 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.

Predicate Devices

• Lyphochek Tumor Marker Control (K940433)

Submission Summary (Full Text)

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DEC 1 6 1998

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Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: [phone]

## 510(k) Summary

Submitter Bio-Rad Laboratories, ECS Division 9500 Jeronimo Road Irvine, CA 92618 [phone] Fax [phone]

Contact Person Elizabeth Platt

Date of Summary Preparation October 27, 1998

Device (Trade & Common Name) Lyphochek Tumor Marker Control

Classification Name Class 1, 75JJY CFR 862.1660: Multi-Analyte Controls, All Kinds (Assayed and Unassayed)

Devices to Which Substantial Equivalence is Claimed

Lyphochek Tumor Marker Control Bio-Rad Laboratories Irvine, CA K940433

## Statement of Intended Use

Lyphochek Tumor Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

## Description of the Device

Lyphochek Tumor Marker Control is prepared from human serum with added constituents of human origin and pure chemicals. The control is provided in lyophilized form for increased stability.

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DEC 16 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K983807 Lyphochek Tumor Marker Control Trade Name: Requlatory Class: I Product Code: JJY Dated: October 27, 1998 Received: October 28, 1998

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 leqally 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 requlations 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 Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory 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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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 labelinq 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 qeneral 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 Sutman

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) Number: __K983807 Device Name: Lyphochek Tumor Marker Control

Indications for Use:

Lyphochek Tumor Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Peter E. Mclain

(Div. in Off)
Div. al Laboratory Devices K983807

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

(Concurrence of CDRH, Office of Device Evaluation)

Prescription Use ✓

OR Over-The Counter Use _