K Number
K081615
Device Name
OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN
Date Cleared
2009-03-18

(282 days)

Product Code
Regulation Number
866.6010
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Otympus CEA assay is a paramagnetic particle (Dynabeads"), chemiluminescent immunoassay for the quantitative determination of carcinoembryonic antigen levels in human serum and litthium heparin plasma using the Olympus AU3000i Immunoassay System. The Olympus CEA assay is indicated for serial measurement of CEA as an aid in the management (monitoning) of coloredal cancer patients. These CEA values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is made. For in vitro diagnostic use only. The Olympus CEA Calibrator is for calibrating the quantitative Olympus CEA assay on the Olympus AU3000i Immunoassay System. The Olympus CEA Control is used for quality control of the Olympus CEA assay on the Olympus AU3000i Immunoassay System.
Device Description
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More Information

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No
The summary describes a standard immunoassay for measuring CEA levels and does not mention any AI or ML components.

No
The device is an in vitro diagnostic assay used for monitoring cancer patients, not for treating them.

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only," which confirms its role as a diagnostic device. It also mentions "quantitative determination of carcinoembryonic antigen levels" and "aid in the management (monitoring) of colorectal cancer patients," which are diagnostic purposes.

No

The device is an in vitro diagnostic assay (immunoassay) which involves chemical reagents and a hardware system (Olympus AU3000i Immunoassay System), not solely software.

Yes, this device is an IVD (In Vitro Diagnostic).

The text explicitly states:

  • "For in vitro diagnostic use only." This is a clear indication that the device is intended for use outside of the body to diagnose or monitor a condition.
  • "The Otympus CEA assay is a paramagnetic particle (Dynabeads"), chemiluminescent immunoassay for the quantitative determination of carcinoembryonic antigen levels in human serum and litthium heparin plasma..." This describes a test performed on biological samples (serum and plasma) outside of the body.
  • "...indicated for serial measurement of CEA as an aid in the management (monitoning) of coloredal cancer patients." This describes the intended medical purpose of the test, which is to provide information for patient management.

These points collectively confirm that the device falls under the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The Otympus CEA assay is a paramagnetic particle (Dynabeads"), chemiluminescent immunoassay for the quantitative determination of carcinoembryonic antigen levels in human serum and litthium heparin plasma using the Olympus AU3000i Immunoassay System. The Olympus CEA assay is indicated for serial measurement of CEA as an aid in the management (monitoning) of coloredal cancer patients. These CEA values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is made. For in vitro diagnostic use only.

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

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

Product codes (comma separated list FDA assigned to the subject device)

DHX, JJX, JIT

Device Description

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Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

Prescription Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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§ 866.6010 Tumor-associated antigen immunological test system.

(a)
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.(b)
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.

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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 8 2009

Olympus America Inc. c/o Ms. Stephanie G. Donnelly Regulatory Affairs/Quality Assurance Manager Olympus Life Science Research Europa GmbH Lisheehan, O'Callaghan's Mills Co. Clare, Ireland

Re: K081615

Trade/Device Name: Olympus Carcinoembryonic antigen (CEA) Regulation Number: 21 CFR 866.6010 Regulation Name: Tumor- associated antigen immunological test system Regulatory Class: II Product Code: DHX, JJX, JIT Dated: February 25, 2009 Received: March 5, 2009

Dear Ms. 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 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. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

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Page 2- Ms. Stephanie G Donnelly

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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 advice for your device on the labeling regulation, 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" (21 CFR Part 807.97). For question 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 many obtain other general information on your responsibilities under the Act from the Division of Small Manufactuers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

i m chan

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): K081615

Device Name: The Olympus Carcinoembryonic antigen (CEA) Test System

Indications For Use:

The Otympus CEA assay is a paramagnetic particle (Dynabeads"), chemiluminescent immunoassay for the quantitative determination of carcinoembryonic antigen levels in human serum and litthium heparin plasma using the Olympus AU3000i Immunoassay System. The Olympus CEA assay is indicated for serial measurement of CEA as an aid in the management (monitoning) of coloredal cancer patients. These CEA values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is made. For in vitro diagnostic use only.

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

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

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

Over-The-Counter

(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)

Katherina Barnard

ion Sian-Off In Vitro Diagnostic Device Evaluation and Safety

K081615
510(k)

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Olympus CEA Assay

510k: K081615

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