IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6

K993952 · Diagnostic Products Corp. · LFZ · Dec 16, 1999 · Microbiology

Device Facts

• Record ID: K993952
• Device Name: IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6
• Applicant: Diagnostic Products Corp.
• Product Code: LFZ · Microbiology
• Decision Date: Dec 16, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3175
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

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.

Device Story

IMMULITE 2000 CMV IgG is an in vitro diagnostic reagent system used with the IMMULITE 2000 Automated Immunoassay Analyzer. It detects IgG antibodies to CMV in human serum. The device uses a solid-phase, two-step chemiluminescent enzyme immunoassay. Patient samples are incubated with CMV antigen-coated polystyrene beads; CMV-specific IgG binds to the antigen. After washing, an alkaline phosphatase-labeled anti-human IgG antibody is added. A chemiluminescent substrate (phosphate ester of adamantyl dioxetane) is introduced; alkaline phosphatase hydrolyzes the substrate, producing light. A luminometer measures photon output, which is proportional to the amount of CMV IgG present. Results are qualitative, determined by comparing sample output to an established cutoff. Used in clinical laboratories by trained personnel to assess CMV serological status. Benefits include identifying past or current CMV exposure, aiding clinical management of patients at risk for severe CMV infection.

Clinical Evidence

Method comparison study performed on 229 human serum samples comparing IMMULITE 2000 CMV IgG to the predicate IMMULITE CMV IgG. Results showed 99.6% overall agreement, 100% relative sensitivity, and 100% relative specificity. No clinical prospective or retrospective outcome studies were required for this 510(k) clearance.

Technological Characteristics

Solid-phase, two-step chemiluminescent enzyme immunoassay. Materials: polystyrene beads coated with partially purified CMV antigen. Energy source: electrical (automated analyzer). Detection: luminometer measuring photon output from adamantyl dioxetane hydrolysis. Connectivity: integrated with IMMULITE 2000 Automated Immunoassay Analyzer. Software: automated instrument control and signal processing.

Indications for Use

Indicated for qualitative detection of IgG antibodies to cytomegalovirus (CMV) in human serum to determine serological status. Not for screening blood or plasma donors. Applicable to all ages, including neonates and immunocompromised individuals (e.g., cancer, organ transplant, AIDS patients).

Regulatory Classification

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.

Predicate Devices

• IMMULITE® CMV IgG (K950672)

Submission Summary (Full Text)

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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

[phone] [phone]

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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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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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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:

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.

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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)

OR

Over-The-Counter Use

(Optional Format 1-2-96)