LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580

K992172 · Bio-Rad · JJY · Sep 2, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992172
• Device Name: LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580
• Applicant: Bio-Rad
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 2, 1999
• 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; prepared from human serum with added human-origin constituents and pure chemicals; provided in lyophilized form for stability. Used by laboratory professionals to monitor precision of testing procedures for various tumor marker analytes. The control is reconstituted and analyzed alongside patient samples; results are compared against expected values provided in the package insert to verify assay performance. Benefits include ensuring accuracy and reliability of clinical laboratory testing for tumor markers, aiding in consistent diagnostic results.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized human serum matrix; stored at 2-8°C. Stability: 14 days at 2-8°C (with specific exceptions for immediate assay) or 30 days frozen at -10°C to -20°C (with specific exceptions).

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 (K983807)

Submission Summary (Full Text)

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**SEP - 2 1999**

K992172

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aboratories

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

## 510(k) Summary

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

Contact Person Elizabeth Platt

Date of Summary Preparation June 25, 1999

Device (Trade & Common Name) Lyphochek Tumor Marker Control

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

Devices to Which Substantial Equivalence is Claimed Lyphochek Tumor Marker Control Bio-Rad Laboratories Irvine, California K983807

## 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.

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

## 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.

## Statement of How Technological Characteristics Compare to Substantial Equivalence Device

A table is provided below comparing the similarities between the Bio-Rad Lyphochek Tumor Marker Control and the devices to which substantial equivalence is claimed.

| | Bio-Rad Lyphochek Tumor Marker<br>Control (New Device) | Bio-Rad Lyphochek Tumor Marker<br>Control (Substantially Equivalent<br>Device) |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | An assayed quality control serum to<br>monitor the precision of laboratory<br>testing procedures for the analytes<br>listed in the package insert. | An assayed quality control serum to<br>monitor the precision of laboratory<br>testing procedures for the analytes<br>listed in the package insert. |
| Form | Lyophilized | Lyophilized |
| Matrix | Human serum | Human serum |
| Storage | 2-8°C | 2-8°C |
| Open Vial<br>Claim | • 14 days when stored tightly<br>capped at 2-8°C, with the following<br>exceptions: ACTH, Free PSA, PSA<br>and Calcitonin should be assayed<br>immediately following<br>reconstitution.<br>• 30 days after reconstituting and<br>freezing at -10°C to -20°C with the<br>following exceptions: (1) PSA will<br>be stable for 20 days when stored<br>frozen at -10°C to -20°C and (2)<br>ACTH and Calcitonin do not have<br>frozen stability claims. | • 14 days when stored tightly<br>capped at 2-8°C, with the following<br>exceptions: ACTH, Free PSA, PSA<br>and Calcitonin should be assayed<br>immediately following<br>reconstitution.<br>• 30 days after reconstituting and<br>freezing at -10°C to -20°C with the<br>following exceptions: (1) PSA will<br>be stable for 20 days when stored<br>frozen at -10°C to -20°C and (2)<br>ACTH and Calcitonin do not have<br>frozen stability claims. |
| Differences | Same analytes as the substantially<br>equivalent device and additional<br>claims for the following : CA 50,<br>CA 195, CA 549 and CASA. | Refer to attached substantially<br>equivalent device product insert. |

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP -2 1999

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

> K992172 Trade Name: Lyphochek Tumor Marker Control Regulatory Class: I Product Code: JJY Dated: June 25, 1999 Received: June 28, 1999

Dear Ms. Platt:

Re:

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 [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: ______________________________________________________________________________________________________________________________________________________________ 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 the package insert.

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

(Concurrence of CDRH, Office of Device Evaluation)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K992172 |

Prescription Use

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2

1994

OR Over-The Counter Use _________________________________________________________________________________________________________________________________________________________