(47 days)
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.
The DPC IMMULITE 2000 CEA is a solid-phase, two site chemiluminescent enzyme immunometric assay for use with the IMMULITE 2000 Automated Analyzer.
The provided document is a 510(k) premarket notification letter from the FDA regarding the IMMULITE 2000 Carcinoembryonic Antigen (CEA) Kit. It confirms the device's substantial equivalence to previously marketed devices. However, this document does not contain the acceptance criteria or details of the study that proves the device meets those criteria.
The letter only states that the FDA has reviewed the 510(k) and found the device substantially equivalent for its intended use, which is for the quantitative measurement of CEA in serum as an aid in the management of cancer patients and in the assessment of prognosis.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from the provided text. This information would typically be found in the 510(k) submission itself, which is not included here.
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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
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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 ----------
§ 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.