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 Description

IMMULITE® 2000 OM-MA is a clinical use device intended for use with the IMMULITE® 2000 Automated Immunoassay Analyzer

AI/ML Overview

The provided text is a 510(k) summary for the IMMULITE® 2000 OM-MA, a reagent system for measuring CA 125 antigen. It primarily focuses on the regulatory aspects and intended use of the device, rather than detailed study protocols or performance data.

Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes, and expert qualifications for ground truth establishment is not present in the provided document.

However, based on the available information, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The 510(k) summary states, "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," but it does not present the actual performance data or the acceptance criteria used to evaluate it.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided in the document.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable/provided. The device described is a reagent system for measuring a biomarker (CA 125 antigen), not an AI-assisted diagnostic imaging device that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable/provided in the context of an "algorithm only" performance study, as this is a laboratory immunoassay device. The device itself is designed for standalone performance in an automated analyzer.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Given the device's intended use ("aid in monitoring the response to therapy for patients with epithelial ovarian cancer, and in detecting residual ovarian cancer"), the ground truth for establishing its effectiveness would likely be based on clinical outcomes data related to ovarian cancer progression, recurrence, or resolution, potentially correlated with other diagnostic methods or pathology results. However, the document does not explicitly state the specific type of ground truth used in the studies supporting the 510(k) submission.

8. The sample size for the training set

This information is not provided in the document.

9. How the ground truth for the training set was established

This information is not provided in the document.

In summary, the provided 510(k) document is a high-level regulatory summary, confirming the device's substantial equivalence to a predicate device, but it lacks the detailed study information typically found in clinical trial reports or technical performance documents.

Summary

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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 StreetLos 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 NameTrade:	IMMULITE® 2000 OM-MA
Common:	Reagent system for the measurement of CA 125antigen in human serum.
Classification:	LTK, class II device
Manufacturer:	Euro/DPC LimitedGlyn RhonwyLanberis, Gwynedd LL55 4ELUnited Kingdom(Manufactured under a Quality System-ISO 9001/EN29001/BS 5750)
Sole U. S. Importer:	Diagnostic Products Corporation5700 West 96th StreetLos Angeles, CA 90045-5597
EstablishmentRegistration #:	Euro/DPC - Not applicableDPC Registration number is 2017183
Substantially EquivalentPredicate Device:	IMMULITE® OM-MA (K981297)
Description of Device:	IMMULITE® 2000 OM-MA is a clinical use deviceintended for use with the IMMULITE® 2000Automated Immunoassay Analyzer
Intended Use of the Device:	IMMULITE® 2000 OM-MA is a solid-phase,chemiluminescent enzyme immunometric assay foruse with the IMMULITE® 2000 AutomatedAnalyzer and designed for the quantitativemeasurement of CA 125 antigen in serum. It isintended strictly for in vitro diagnostic use as an aidin monitoring the response to therapy for patientswith epithelial ovarian cancer, and in detectingresidual ovarian cancer in patients who haveundergone first-line therapy and would beconsidered for diagnostic second-look procedures.

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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

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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.

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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

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510(k) Number (if known):_

Device Name:_IMMULITE® 2000

Indications For Use:

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(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

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Over-The-Counter Use

(Optional Format 1-2-

Regulation Number and Section

§ 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.