ST AIA-PACK CEA ENZYME IMMUNOASSAY

K023893 · Tosoh Medics, Inc. · DHX · Dec 18, 2002 · Immunology

Device Facts

• Record ID: K023893
• Device Name: ST AIA-PACK CEA ENZYME IMMUNOASSAY
• Applicant: Tosoh Medics, Inc.
• Product Code: DHX · Immunology
• Decision Date: Dec 18, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Intended Use

ST AIA-PACK CEA is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Carcinoembryonic Antigen (CEA) in human serum to aid in the management of cancer patients in whom changing concentrations of CEA are observed on specific TOSOH AIA System analyzers.

Device Story

ST AIA-PACK CEA is a two-site immunoenzymometric assay for quantitative measurement of CEA in human serum. Input: human serum sample. Principle: CEA binds to monoclonal antibody immobilized on magnetic solid phase and enzyme-labeled monoclonal antibody within the AIA-PACK. Magnetic beads are washed to remove unbound label, then incubated with fluorogenic substrate 4-methylumbelliferyl phosphate (4MUP). Output: fluorescence intensity proportional to CEA concentration. Used in clinical laboratory settings on TOSOH AIA System analyzers. Healthcare providers use results to monitor changing CEA concentrations in cancer patients, aiding clinical management.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on analytical performance characteristics and design modifications to a previously cleared predicate device.

Technological Characteristics

Two-site immunoenzymometric assay. Components: monoclonal antibodies, magnetic solid phase, enzyme-labeled monoclonal antibody, 4-methylumbelliferyl phosphate (4MUP) substrate. Form factor: AIA-PACK reagent cartridge. Analyte: Carcinoembryonic Antigen (CEA). Detection: fluorometric.

Indications for Use

Indicated for the quantitative measurement of Carcinoembryonic Antigen (CEA) in human serum to aid in the management of cancer patients. For use on specific TOSOH AIA System analyzers. Prescription use only.

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 CEA (P910053)

Reference Devices

• AIA-PACK CEA (P910006)

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 stylized four-leaf clover shape with a square in the center, followed by the text "TOSOH MEDICS, INC." The word "TOSOH" is also printed below the clover shape. A horizontal line is placed below the word "TOSOH".

### 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: H0238893

| 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 CEA |
| Classification Name: | System, Test, Carcinoembryonic Antigen |
| Predicate Device: | Tosoh AIA-PACK CEA<br>Tosoh Corporation<br>Tokyo, Japan<br>P910053 |

### Device Description:

The ST AIA-PACK CEA is a two-site immunoenzymometric assay which is performed entirely in the AIA-PACK. CEA present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the AJA-PACK. The magnetic beads are washed to remove unbound enzyme-labeled monoclonal antibody and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the CEA 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 AIA-PACK CEA is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Carcinoembryonic Antigen (CEA) in human serum to aid in the management of cancer patients in whom changing concentrations of CEA are observed on specific TOSOH AIA System analyzers.

# Substantial Equivalence:

This Special 510(k) is for a modification in the packaging, incubation period, conjugate concentration and certain components of the conjugate diluent of the AIA-PACK CEA, which was previously cleared as P910006 on February 19, 1993. The intended use, assay principles, antibody type, analyte detected, and performance characteristics of both assays are equivalent.

### Conclusion:

The modified ST AIA-PACK CEA, as described in this Special 510(k) is substantially equivalent to the predicate device. The proposed modifications in packaging, incubation period, conjugate and conjugate diluent 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-leaf clover shape in black, with a white square in the center. Below the logo, the word "TOSOH" is printed in a simple, sans-serif font.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administrat 2098 Gaither Road Rockville MD 20850

DEC 1 8 2002

Ms. Lois Nakayama Manager, Quality Assurance Tosoh Medics, Inc. 347 Ovster Point Blvd. - Suite 201 South San Francisco, CA 94080

Re:

k023893 Trade/Device Name: ST AIA-PACK CEA Enzyme Immunoassay Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: Class II Product Code: DHX: JIS 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, 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 (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 lisuing (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).

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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.

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 and white symbol that looks like a plus sign with rounded edges and a square in the center. To the right of the symbol is the text "TOSOH MEDICS, INC." in a bold, sans-serif font.

### Indications for Use Statement

**Device Name**

Indications for Use

ST AIA-PACK CEA Enzyme Immunoa

ST AIA-PACK CEA is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Carcinoembryonic Antigen (CEA) in human serum to aid in the management of cancer patients in whom changing concentrations of CEA are observed on specific TOSOH AIA System Analyzers.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

A. P. Lever for J. Bautista

(Division Sign-Off) Division of Clinical Laboratory Devices 102-3893 510(k) Number .

Prescription Use √
(Per 21CFR 801.109)

OR

Over-The-Counter Use