ST AIA-PACK CA 19-9

K023240 · Tosoh Corp. · NIG · Dec 23, 2002 · Immunology

Device Facts

• Record ID: K023240
• Device Name: ST AIA-PACK CA 19-9
• Applicant: Tosoh Corp.
• Product Code: NIG · Immunology
• Decision Date: Dec 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Indications for Use

ST AIA-PACK™ CA 19-9 is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 19-9 tumor associated antigen in human serum on TOSOH AIA Nex•IA and AIA-600II Immunoassay analyzers. Serial testing using the ST AIA-PACK™ CA 19-9 is to be used as an aid in monitoring the disease status in patients who have been diagnosed with pancreatic cancer and who show measurable CA 19-9 results over the course of their disease. Results of CA 19-9 testing should be used in conjunction with other clinical methods that are standard of care for monitoring disease status in these patients.

Device Story

ST AIA-PACK CA 19-9 is an in vitro diagnostic immunoassay for quantitative measurement of CA 19-9 tumor-associated antigen in human serum. Device operates on TOSOH AIA Nex•IA and AIA-600II analyzers. Used by laboratory professionals to perform serial testing on patients with diagnosed pancreatic cancer. Output provides quantitative antigen levels to assist clinicians in monitoring disease progression or response to therapy. Results are intended for use alongside other standard clinical diagnostic methods. Benefits include objective tracking of tumor marker levels over time to support clinical decision-making in oncology management.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

In vitro diagnostic immunoassay; quantitative measurement of CA 19-9 antigen in human serum; designed for use on TOSOH AIA Nex•IA and AIA-600II automated immunoassay analyzers.

Indications for Use

Indicated for serial monitoring of disease status in patients diagnosed with pancreatic cancer who exhibit measurable CA 19-9 levels. For use in clinical laboratories as an aid to standard 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 23 2002

Ms. Judith E. Loebel Director of Clinical and Regulatory Affairs Diagnostic Oncology CRO, Inc. 73 Cogwheel Lane Seymour, CT 06483

k023240 Re:

Trade/Device Name: ST AIA-PACK TM CA 19-9 Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated antigen immunological test system Regulatory Class: Class II Product Code: NIG: JIS Dated: December 8, 2002 Received: December 10, 2002

Dear Ms. Loebel:

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 vour 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 (OS) 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 Putman

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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# 510(k) Number (if known): I

Device Name:

## Indications For Use:

#### ST AIA-PACK™ CA 19-9

ST AIA-PACK™ CA 19-9 is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 19-9 tumor associated antigen in human serum on TOSOH AIA Nex•IA and AIA-600II Immunoassay analyzers. Serial testing using the ST AIA-PACK™ CA 19-9 is to be used as an aid in monitoring the disease status in patients who have been diagnosed with pancreatic cancer and who show measurable CA 19-9 results over the course of their disease. Results of CA 19-9 testing should be used in conjunction with other clinical methods that are standard of care for monitoring disease status in these patients.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 fleurs for J. Bautista

on Sign-Off) Division of Clinical Laborator 510(k) Number

OR

Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use

(Optional Format 1-2-96)