For in vitro use with the IMMULITE® 2000 Automated Analyzer - for the qualitative detection of IgG antibodies to cytomegalovirus (CMV) in human serum as an aid in the determination of serological status to CMV. This kit is not cleared for use in testing (i.e. screening) blood or plasma donors.

Device Description

IMMULITE® 2000 CMV IgG is a clinical use device intended for use with the IMMULITE® 2000 Automated Immunoassay Analyzer. IMMULITE® 2000 CMV IgG is a chemiluminescent immunoassay. The sold phase, a polystyrene bead enclosed within an IMMULITE Test Unit/IMMULITE 2000 Reaction Tube is coated with partially purified CMV antigen. One-in-twenty one prediluted patient sample for IMMULITE/instrument-diluted patient sample for IMMULITE 2000 and a protein-based buffer are simultaneously introduced into the Test Unit (IMMULITE)/Reaction Tube (IMMULITE 2000), and incubated for approximately 30 minutes at 37℃ with intermittent agitation. During this time, CMV-specific IgG in the sample binds to the CMV antigen-coated bead. Unbound serum is then removed by a centrifugal wash. In both procedures, an alkaline phosphatase-labeled anti-human IgG antibody is introduced, and the Test Unit/Reaction Tube is incubated for another 30-minute cycle. The unbound enzyme conjugate is removed by a centrifugal wash. Substrate is then added, and the Test Unit/Reaction Tube is incubated for a further 10 minutes (IMMULITE)/5 minutes (IMMULITE 2000). In both procedures, the chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output, as measured by the luminometer - is related to the presence of CMV IgG in the sample. A qualitative result is then obtained by comparing the patient result to an established cutoff.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined set of targets. Instead, it presents a "Performance Equivalence - Method Comparison" study with the implicit understanding that high agreement, relative sensitivity, and relative specificity with the predicate device are the metrics for demonstrating equivalence.

Performance Metric	Acceptance Criteria (Implicit)	Reported Device Performance (IMMULITE® 2000 CMV IgG vs. IMMULITE® CMV IgG)
Agreement	High agreement (e.g., >95%)	99.6%
Relative Sensitivity	High sensitivity (e.g., >95%)	100%
Relative Specificity	High specificity (e.g., >95%)	100%

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 229 samples.
Data Provenance: The document does not specify the country of origin for the samples or whether they were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish ground truth for this comparison study. The comparison is between two devices, implying that the ground truth for this study is essentially the performance of the predicate device (IMMULITE® CMV IgG).

4. Adjudication Method for the Test Set

No adjudication method is described. The comparison is a direct method comparison between two assays.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

An MRMC study was not conducted. This is a comparison between two automated immunoassay devices, not a study involving human readers with and without AI assistance.

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

Yes, this study is a standalone performance assessment of the new IMMULITE® 2000 CMV IgG device against a predicate device (IMMULITE® CMV IgG). Both are automated immunoassay systems, operating without human interpretation in the results generation process depicted here.

7. The Type of Ground Truth Used

The "ground truth" for this performance equivalence study is the performance of the predicate device, IMMULITE® CMV IgG. The study aims to demonstrate that the new device performs equivalently to an already cleared device.

8. The Sample Size for the Training Set

The document does not provide information about a separate training set for the IMMULITE® 2000 CMV IgG device. This submission is for a new iteration of an immunoassay, and the focus is on demonstrating equivalence to a previous version rather than presenting a de novo algorithm training process.

9. How the Ground Truth for the Training Set was Established

As no training set is described, there's no information on how its ground truth would have been established. It's likely that the original IMMULITE® CMV IgG (the predicate device) would have undergone its own validation studies where ground truth for determining CMV IgG status was established through methods like clinical diagnosis, seroconversion panels, or other established laboratory methods for infectious disease diagnosis.

Summary

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Image /page/0/Picture/3 description: The image contains a sequence of handwritten alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '993952'. The characters are written in a dark ink, and the style appears to be cursive.

DEC 1 6 1999

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: Address:

Telephone Number: Facsimile Number:

Contact Person:

Date of Preparation: .

Catalog Number:

Device Name Trade:

Common:

Classification:

Manufacturer:

Establishment Registration #:

Substantially Equivalent Predicate Device:

Description of Device:

Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597

(310) 645-8200 (310) 645-9999

Edward M., Levine, Ph.D. Director of Clinical Affairs

December 10, 1999

L2KCV2 (200 tests), L2KCV6 (600 tests)

IMMULITE® 2000 CMV IgG

Reagent system for the detection of IgG antibodies to cytomegalovirus (CMV) in human serum.

Class II device, LFZ (21CFR 866.3175)

Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045-5597

DPC Registration number is 2017183

IMMULITE® CMV IgG (K950672)

IMMULITE® 2000 CMV IgG is a clinical use device intended for use with the IMMULITE® 2000 Automated Immunoassay Analyzer

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Intended Use of the Device:

IMMULITE® 2000 CMV IgG is for in vitro use with the IMMULITE 2000 Analyzer - for the qualitative detection of IgG antibodies to cytomegalovinis (CMV) in human serum as an aid in the determination of serological status of CMV. This kit is not FDA cleared for use in testing (i.e. screening) blood or plasma donors.

Summary and Explanation of the Test:

Cytomegalovirus (CMV), a member of the herpesvirus family, is found throughout the world. Humans of all ages are susceptible and infection is spread through sexual contact, direct exposure to infected body fluids, blood transfusions and organ transplants. The majority of infections are asymptomatic: however. CMV infections can be severe in neonates and immunocompromised individuals. Infection can also be severe in patients with congenital or acquired cellar immune defects, including cancer patients, organ recipients and AIDS patients.

CMV is the most common congenital infection, infecting between 0.5 and 2.5 percent of newborn infants. Five percent of these will develop classic cytomegalic inclusion disease with jaundice, pneumonia and central nervous system disorder. Infected infants may be asymptomatic at birth, but can develop neurological problems later in life.

Between 40 and 100 percent of people have detectable antibody, with the prevalence highest in developing countries.

Performance Equivalence - Technology Comparison:

IMMULITE® and IMMULITE® 2000 CMV IgG are chemiluminescent immunoassays. The technology in DPC's IMMULITE® 2000 CMV IgG is a unique combination of technologies employed in previously cleared and commercially marketed DPC products.

Both IMMULITE® and IMMULITE® 2000 CMV IgG assays are solid-phase, two step chemiluminescent enzyme immunoassay. The sold phase, a polystyrene bead enclosed within an IMMULITE Test Unit/IMMULITE 2000 Reaction Tube is coated with partially purified CMV antigen.

One-in-twenty one prediluted patient sample for IMMULITE/instrument-diluted patient sample for IMMULITE 2000 and a protein-based buffer are simultaneously introduced into the Test Unit (IMMULITE)/Reaction Tube (IMMULITE 2000), and incubated for approximately 30 minutes at 37℃ with intermittent agitation. During this time, CMV-specific IgG in the sample binds to the CMV antigen-coated bead. Unbound serum is then removed by a centrifugal wash,

In both procedures, an alkaline phosphatase-labeled anti-human IgG antibody is introduced, and the Test Unit/Reaction Tube is incubated for another 30-minute cycle. The unbound enzyme conjugate is removed by a centrifugal wash. Substrate is then added, and the Test Unit/Reaction Tube is incubated for a further 10 minutes (IMMULITE)/5 minutes (IMMULITE 2000).

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In both procedures, the chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus also the photon output, as measured by the luminometer - is related to the presence of CMV IgG in the sample. A qualitative result is then obtained by comparing the patient result to an established cutoff.

Performance Equivalence - Method Comparison:

The IMMULITE® 2000 CMV IgG procedure was compared to IMMULITE® CMV IgG on 229 samples, with the following result.

	IMMULITE 2000
IMMULITE	Pos	Indeterminate	Neg
Pos	165	0	0	Agreement:	99.6%
Indeterminate	0	0	1	Relative Sensitivity:	100%
Neg	0	0	63	Relative Specificity:	100%

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 CMV IgG.

Edward M. Levine, Ph.D.

Director of Clinical Affairs

12/10/85
Date

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, with flowing lines representing hair or clothing.

DEC 1 6 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Edward M. Levin, Ph.D. Director of Clinical Affairs Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597

Re: K993952 Trade Name: IMMULITE® 2000 CMV IgG Regulatory Class: II Product Code: LFZ Dated: November 19, 1999 Received: November 22, 1999

Dear Dr. Levin:

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 Regulations, 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 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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Page 2

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 Sutman

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): K993952 Device Name: IMMULITE® 2000 CMV IgG

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubois

Division of Clinical Laboratory Devices 1993952 510(k) Number

X
Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 866.3175 Cytomegalovirus serological reagents.

(a)
Identification. Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.(b)
Classification. Class II (performance standards).