ST AIA-PACK CA 125 ENZYME IMMUNOASSAY

K023891 · Tosoh Medics, Inc. · LTK · Dec 6, 2002 · Immunology

Device Facts

• Record ID: K023891
• Device Name: ST AIA-PACK CA 125 ENZYME IMMUNOASSAY
• Applicant: Tosoh Medics, Inc.
• Product Code: LTK · Immunology
• Decision Date: Dec 6, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Indications for Use

ST AIA-PACK CA 125 is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 125 in human serum on specific TOSOH AIA System analyzers. ST 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

ST AIA-PACK CA 125 is a two-site immunoenzymometric assay for quantitative measurement of CA 125 in human serum. Input: human serum sample. Principle: CA 125 binds to monoclonal antibody on magnetic solid phase and enzyme-labeled monoclonal antibody; magnetic beads washed to remove unbound label; incubation with fluorogenic substrate (4-methylumbelliferyl phosphate). Output: CA 125 concentration calculated via standard curve. Used in clinical laboratories on TOSOH AIA System analyzers; operated by laboratory technicians. Results assist healthcare providers in monitoring ovarian cancer therapy response. Benefits: provides quantitative data for serial monitoring of disease status.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of assay characteristics to the predicate device.

Technological Characteristics

Two-site immunoenzymometric assay. Components: monoclonal antibody immobilized on magnetic solid phase, enzyme-labeled monoclonal antibody, fluorogenic substrate (4-methylumbelliferyl phosphate). Form factor: AIA-PACK reagent system. Analyzers: TOSOH AIA System. Principle: Enzyme-linked immunoassay with magnetic separation.

Indications for Use

Indicated for quantitative measurement of CA 125 in human serum to monitor therapy response in patients with epithelial ovarian cancer. Serial testing to be used alongside 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.

Predicate Devices

• Tosoh AIA-PACK CA 125 (K990431)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Tosoh Medics, Inc. The logo consists of a black four-leaf clover shape with a white square in the center, followed by the text "TOSOH MEDICS, INC." in a bold, sans-serif font. Below the clover is the word "TOSOH" in a smaller font, and a horizontal line extends from the word to the right.

#### DEC 0 6 2002 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _______________________________________________________________________________________________________________________________________________

| Submitter: | Tosoh Medics, Inc.<br>347 Oyster Point Blvd., Suite 201<br>South San Francisco, CA 94080<br>Phone: [phone]<br>Fax: [phone] |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Lois Nakayama<br>Manager, Quality Assurance |
| Date of Summary Preparation: | November 8, 2002 |
| Device Name: | ST AIA-PACK CA 125 |
| Classification Name: | Test, Epithelial Ovarian Tumor-Associated Antigen |
| Predicate Device: | Tosoh AIA-PACK CA 125<br>Tosoh Corporation<br>Tokyo, Japan<br>K990431 |

# Device Description:

The ST AIA-PACK CA 125 is a two-site immunoenzymometric assay which is performed entirely in the AIA-PACK. CA 125 present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the AIA-PACK. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbellifery| phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the CA 125 concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.

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### Statement of Intended Use:

ST AJA-PACK CA 125 is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 125 in human serum on specific TOSOH AIA System analyzers. ST 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.

# Substantial Equivalence:

This Special 510(k) is for a modification in the packaging and incubation period of the AIA-PACK CA 125. which was previously cleared as K990431 on June 3, 1999. The intended use, assay principles, antibody type, analyte detected, and performance characteristics of both assays are equivalent.

### Conclusion:

The modified ST AIA-PACK CA 125, as described in this Special 510(k) is substantially equivalent to the predicate device. The proposed modifications in packaging and incubation period are not substantial changes and do not affect the safety and effectiveness of the device.

Image /page/1/Picture/6 description: The image shows the logo for TOSOH. The logo consists of a stylized, four-lobed shape resembling a plus sign with rounded edges, with a square cut out in the center. Below the symbol, the word "TOSOH" is printed in a simple, sans-serif font.

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# . DEPARTMENT OF HEALTH & HUMAN SERVICES

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Re:

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

Ms. Lois Nakayama Manager, Quality Assurance Tosoh Medics, Inc. 347 Oyster Point Boulevard, Suite 201 South San Francisco, California 94080

DEC 0 6 2002

k023891 -Trade/Device Name: ST AIA-PACK CA 125 Regulation Number: 21 CFR § 866.6010 Regulation Name: Test, Epithelial Ovarian Tumor-Associated Antigen Regulatory Class: II Product Code: LTK Dated: November 20, 2002 Received: November 22, 2002

Dear Ms. Nakayama:

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. Iisting 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 your 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). 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.

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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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Image /page/4/Picture/0 description: The image shows the logo for Tosoh Medics, Inc. The logo consists of a black cross-like symbol with a white square in the center, followed by the text "TOSOH MEDICS, INC." to the right. Below the symbol, the text "TOSOH" is written in a smaller font size.

K023891

#### Indications for Use Statement

| Device Name | ST AIA-PACK CA 125 Enzyme Immunoassay |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | ST AIA-PACK CA 125 is designed for IN VITRO<br>DIAGNOSTIC USE ONLY for the quantitative<br>measurement of CA 125 in human serum on specific<br>TOSOH AIA System analyzers. ST AIA-PACK CA 125 is<br>to be used as an aid in monitoring response to therapy<br>for patients with epithelial ovarian cancer. Serial testing<br>for patient CA 125 assay values should be used in<br>conjunction with other clinical methods used for monitoring<br>ovarian cancer. |

# PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

H. Reeves for J. Bautista

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K023891

سنيPrescription Use (Per 21CFR 801.109) OR

Over-The-Counter Use_