OLYMPUS AFP - ALPHA-FETOPROTEIN

K081709 · Olympus Life Science Research Europa GmbH (Europa) · LOJ · Mar 16, 2009 · Immunology

Device Facts

• Record ID: K081709
• Device Name: OLYMPUS AFP - ALPHA-FETOPROTEIN
• Applicant: Olympus Life Science Research Europa GmbH (Europa)
• Product Code: LOJ · Immunology
• Decision Date: Mar 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.6010
• Device Class: Class 2

Intended Use

The Olympus AFP assay is a paramagnetic particle (Dynabeads®), chemiluminescent immunoassay for the quantitative determination of alpha-fetoprotein levels in human serum/plasma using the Olympus AU3000i Immunoassay System. The Olympus AFP assay is intended for use as an aid in the management (monitoring) of patients with non-seminomatous germ cell tumors. The Olympus AFP calibrator is for calibrating the quantitative Olympus assay on the Olympus AU3000i Immunoassay. The Olympus AFP control is used for the quality control of the Olympus AFP assay on the Olympus AU3000i Immunoassay System.

Device Story

The Olympus AFP Test System is an in vitro diagnostic immunoassay for measuring alpha-fetoprotein levels in human serum and lithium heparin plasma. It utilizes paramagnetic particles (Dynabeads®) and chemiluminescent detection technology. The assay is designed for operation on the Olympus AU3000i Immunoassay System. The system processes patient samples to provide quantitative AFP results, which clinicians use as an aid in managing patients diagnosed with non-seminomatous germ cell tumors. The system includes dedicated calibrators and controls to ensure measurement accuracy and quality control. It is intended for professional use in clinical laboratory settings.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and performance validation of the immunoassay system.

Technological Characteristics

Two-step paramagnetic particle enzyme immunoassay. Reagents: paramagnetic particles coated with murine monoclonal anti-AFP antibody, alkaline phosphatase-labeled anti-AFP antibody conjugate. Measuring range: 0.1–390 ng/mL. Traceable to 1st IRP WHO Reference Standard 72/225. Instrument: Olympus AU3000i Immunoassay System. Sample type: serum and Li-heparin plasma. Storage: 2-8°C.

Indications for Use

Indicated for the quantitative determination of alpha-fetoprotein (AFP) in human serum and lithium heparin plasma to aid in the management of patients with non-seminomatous germ cell tumors.

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

## MAR 1 6 2009

Olympus America, Inc. c/o Stephanie G. Donnelly Global Regulatory Affairs Manager Olympus Life Science Research Europe Lismeehan O'Callaghans Mills, Co. Clare, Ireland

Rc: k081709

Trade/Device Name: Olympus AFP Test System Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor-associated antigen immunological test system. Regulatory Class: Class II Product Code: LOJ, JIT, JJX Dated: February 20, 2009 Received: February 23, 2009

Dear Ms. Stephanie G Donnelly:

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 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

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Page 2 - Ms. Stephanie G. Donnelly

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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Arana m. Chen

Maria M. Chan, Ph.D Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

## 510(k) Number (if known): K081709

#### Device Name: The Olympus Alpha-fetoprotein (AFP) Test System

#### Indications For Use:

The Olympus AFP assay is a paramagnetic particle (Dynabeads®), chemiluminescent immunoassay for the quantitative determination of alpha-fetoprotein levels in human serum and lithium heparin plasma using the Olympus AU3000i Immunoassay System. The Olympus AFP assay is intended for use as an aid in the management of patients with non-seminomatous germ cell tumors.

For in vitro diagnostic use only.

The Olympus AFP Calibrator is for calibrating the quantitative Olympus AFP assay on the Olympus AU3000i Immunoassay System.

The Olympus AFP Control is used for quality control of the Olympus AFP assay on the Olympus AU3000i Immunoassay System.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Karen R. Swearing

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

\$\frac{k\ 0.81709}{510(k)}\$

( הייתר העירות המקום מדינו יותר הב כמה ה הביט המועד המועד המוני וני נוצאו ו.

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