← Product Code [LTK](/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/LTK) · K983391 # IMMULITE 2000 OM-MA MODEL L2KOP2 (K983391) _Diagnostic Products Corp. · LTK · Oct 15, 1998 · Immunology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/LTK/K983391 ## Device Facts - **Applicant:** Diagnostic Products Corp. - **Product Code:** [LTK](/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/LTK.md) - **Decision Date:** Oct 15, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.6010 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Indications for Use IMMULITE® 2000 OM-MA is a solid-phase, chemiluminescent enzyme immunometric assay for use with the IMMULITE® 2000 Automated Analyzer and designed for the quantitative measurement of CA 125 antigen in serum. It is intended strictly for in vitro diagnostic use as an aid in monitoring the response to therapy for patients with epithelial ovarian cancer, and in detecting residual ovarian cancer in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures. ## Device Story IMMULITE® 2000 OM-MA is an in vitro diagnostic reagent system used with the IMMULITE® 2000 Automated Immunoassay Analyzer. It performs a solid-phase, chemiluminescent enzyme immunometric assay to quantitatively measure CA 125 antigen in human serum. The system is operated by laboratory personnel in a clinical setting. The analyzer processes the sample, performs the immunoassay, and generates a quantitative result. Clinicians use these results to monitor therapeutic response in epithelial ovarian cancer patients and to identify residual disease in patients undergoing second-look procedures. The device aids clinical decision-making by providing objective biomarker data to assess treatment efficacy and disease status. ## Clinical Evidence No clinical data provided; substantial equivalence is based on bench testing and performance comparison to the predicate device. ## Technological Characteristics Solid-phase, chemiluminescent enzyme immunometric assay. Designed for use on the IMMULITE® 2000 Automated Immunoassay Analyzer. Manufactured under ISO 9001/EN29001/BS 5750 quality systems. ## Regulatory 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. ## Predicate Devices - IMMULITE® OM-MA ([K981297](/device/K981297.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ KG8339/ OIT 1 5 1998 ## 510 (k) Summary Safety and Effectiveness This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92. | Name: | Diagnostic Products Corporation | |-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address: | 5700 West 96th Street
Los Angeles, California 90045-5597 | | Telephone Number: | (310) 645-8200 | | Facsimile Number: | (310) 645-9999 | | Contact Person: | Edward M. Levine, Ph.D.
Director of Clinical Affairs | | Date of Preparation: | September 23, 1998 | | Catalog Number: | L2KOP2 | | Device Name
Trade: | IMMULITE® 2000 OM-MA | | Common: | Reagent system for the measurement of CA 125
antigen in human serum. | | Classification: | LTK, class II device | | Manufacturer: | Euro/DPC Limited
Glyn Rhonwy
Lanberis, Gwynedd LL55 4EL
United Kingdom
(Manufactured under a Quality System-
ISO 9001/EN29001/BS 5750) | | Sole U. S. Importer: | Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, CA 90045-5597 | | Establishment
Registration #: | Euro/DPC - Not applicable
DPC Registration number is 2017183 | | Substantially Equivalent
Predicate Device: | IMMULITE® OM-MA (K981297) | | Description of Device: | IMMULITE® 2000 OM-MA is a clinical use device
intended for use with the IMMULITE® 2000
Automated Immunoassay Analyzer | | Intended Use of the Device: | IMMULITE® 2000 OM-MA is a solid-phase,
chemiluminescent enzyme immunometric assay for
use with the IMMULITE® 2000 Automated
Analyzer and designed for the quantitative
measurement of CA 125 antigen in serum. It is
intended strictly for in vitro diagnostic use as an aid
in monitoring the response to therapy for patients
with epithelial ovarian cancer, and in detecting
residual ovarian cancer in patients who have
undergone first-line therapy and would be
considered for diagnostic second-look procedures. | {1}------------------------------------------------ ### Conclusion: The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for IMMULITE 2000 OM-MA Eliviccl S. Levin Edward M. Levine, Ph. D Director of Clinical Affairs 9/14/98 Date Date {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the head, body, and tail feathers. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services. OCT 1 5 1998 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Edward M. Levine, Ph.D. Director of Clinical Affairs Diaqnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045 Re: K983391 IMMULITE® 2000 OM-MA and IMMULITE® OM-MA Control Trade Name: Module Catalog # L2KOP2 (200 Tests) LOMCM (Control Module) Requlatory Class: II Product Code: LTK Dated: September 23, 1998 September 25, 1998 Received: Dear Dr. Levine: 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 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. 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 requlatory 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 obliqation 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. {3}------------------------------------------------ Paqe 2 This letter will allow you to beqin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 (301) 443-6597, 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ 510(k) Number (if known):_ # Device Name:_IMMULITE® 2000 Indications For Use: ) IMMULITE® 2000 OM-MA is a solid-phase, chemiluminescent enzyme immunometric assay for use with the IMMULITE® 2000 Automated Analyzer and designed for the quantitative measurement of CA 125 antigen in serum. It is intended strictly for in vitro diagnostic use as an aid in monitoring the response to therapy for patients with epithelial ovarian cancer, and in detecting residual ovarian cancer in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures. # (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Deyice Evaluation (ODE) Tista E. Madni (Division Sign-Off) Division of Clinical Laboratory Devices K98331 510(k) Number ✓ OR Over-The-Counter Use (Optional Format 1-2- 96) --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/LTK/K983391](https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/LTK/K983391) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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