K Number
K980855
Device Name
IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT
Manufacturer
Date Cleared
1998-04-21

(47 days)

Product Code
Regulation Number
866.6010
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DPC IMMULITE 2000 CEA is a solid-phase, two site chemiluminescent enzyme immunometric assay for use with the IMMULITE 2000 Automated Analyzer and designed for the quantitative measurement of carcinoembryonic antigen (CEA) in serum. It is intended for in vitro diagnostic use as an aid in the management of cancer patients and in the assessment of prognosis.
Device Description
The DPC IMMULITE 2000 CEA is a solid-phase, two site chemiluminescent enzyme immunometric assay for use with the IMMULITE 2000 Automated Analyzer.
More Information

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Not Found

No
The summary describes a standard immunoassay kit and automated analyzer, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.

No
The device is an in vitro diagnostic assay used for the quantitative measurement of CEA in serum, intended as an aid in the management of cancer patients and assessment of prognosis, not for direct therapeutic intervention.

Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "It is intended for in vitro diagnostic use".

No

The device description clearly states it is a "solid-phase, two site chemiluminescent enzyme immunometric assay," which is a chemical and biological reagent-based test, not a software-only device. It is used with an automated analyzer, but the device itself is the assay kit.

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

The "Intended Use / Indications for Use" section explicitly states:

"It is intended for in vitro diagnostic use as an aid in the management of cancer patients and in the assessment of prognosis."

This statement clearly indicates that the device is designed to be used outside of the body (in vitro) for diagnostic purposes.

N/A

Intended Use / Indications for Use

The DPC IMMULITE 2000 CEA is a solid-phase, two site chemiluminescent enzyme immunometric assay for use with the IMMULITE 2000 Automated Analyzer and designed for the quantitative measurement of carcinoembryonic antigen (CEA) in serum. It is intended for in vitro diagnostic use as an aid in the management of cancer patients and in the assessment of prognosis.

Product codes

DHX

Device Description

a solid-phase, two site chemiluminescent enzyme immunometric assay for use with the IMMULITE 2000 Automated Analyzer and designed for the quantitative measurement of carcinoembryonic antigen (CEA) in serum.

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

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

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Summary of Performance Studies

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Key Metrics

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Predicate Device(s)

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Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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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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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing segments, representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

APR 2 1 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Robert M Di Tullio Director, Quality and Requlatory Affairs Diagnostic Products Corporation (DPC) B13-B18, 111 Canfield Avenue Randolph, New Jersey 07869

Re : K980855 IMMULITE 2000 Carcinoembryonic Antigen (CEA) Kit Trade Name: Requlatory Class: II Product Code: DHX Dated: March 4, 1998 March 5, 1998 Received:

Dear Mr. Tullio:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. TO determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

510(k) Number (if known):

Device Name: IMMULITE 2000 CEA

Indications for Use:

The DPC IMMULITE 2000 CEA is a solid-phase, two site chemiluminescent enzyme immunometric assay for use with the IMMULITE 2000 Automated Analyzer and designed for the quantitative measurement of carcinoembryonic antigen (CEA) in serum. It is intended for in vitro diagnostic use as an aid in the management of cancer patients and in the assessment of prognosis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter E. Macias

(Division Sign-Off) Division of Clinical Laboratory Devices

510(k) Number K980855

Prescription Use

OR

Over-The-Counter Use ----------