AIA-PACK CA 125

K990431 · Tosoh Medics, Inc. · LTK · Jun 3, 1999 · Immunology

Device Facts

• Record ID: K990431
• Device Name: AIA-PACK CA 125
• Applicant: Tosoh Medics, Inc.
• Product Code: LTK · Immunology
• Decision Date: Jun 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Indications for Use

AIA-PACK CA 125 is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 125 in human serum on TOSOH AIA System analyzers. AIA-PACK CA 125 is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

Device Story

AIA-PACK CA 125 is an in vitro diagnostic assay for quantitative measurement of CA 125 antigen in human serum. Used on TOSOH AIA System analyzers; operates via automated immunoassay technology. Provides serial CA 125 concentration values to clinicians to monitor therapeutic response in epithelial ovarian cancer patients. Results are interpreted alongside other clinical diagnostic methods. Intended for professional use in clinical laboratory settings.

Technological Characteristics

In vitro diagnostic immunoassay for use on TOSOH AIA System analyzers. Quantitative measurement of CA 125 in human serum.

Indications for Use

Indicated for the quantitative measurement of CA 125 in human serum to monitor therapy response in patients with epithelial ovarian cancer. Intended for use in conjunction with other clinical monitoring methods.

Regulatory Classification

Identification

A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.

Special Controls

*Classification.* Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.

Submission Summary (Full Text)

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3 1999 JUN

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Judith E. Loebel Director of Customer Support Tosoh Medics, Inc. 347 Oyster Point Boulevard, Suite 201 South San Francisco, California 94080

Re: K990431 Trade Name: AIA-PACK CA 125 Assay Regulatory Class: II Product Code: LTK Dated: April 30, 1999 Received: May 3, 1999

Dear Ms. Loebel:

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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## PREMARKET NOTIFICATION

## INDICATION FOR USE STATEMENT

## AIA-PACK CA 125

AIA-PACK CA 125 is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 125 in human serum on TOSOH AIA System analyzers. AIA-PACK CA 125 is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

Peta E. Makoni

10ivision Sign-Off) Division of Clinical Laboratory Devic 510(k) Number

Prescription
Use

0004