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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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BK070028 Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: ___________

 

1.  Submitter Name, Address and Contact

 

Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester, New York 14626-5101
(585) 453-4131

Contact Person: Leah Van De Water

 

2.  Preparation Date

 

Date 510(k) prepared: May 31, 2007

 

3.  Device Name

 

Trade or Proprietary Name: VITROS Immunodiagnostic Products Anti-HIV 1+2 Controls
Common Name: Anti-HIV 1+2 Controls
Classification Name: 21 CFR 862.1660 Quality Control Material (Assayed and Unassayed)

 

4.  Predicate Device

 

The VITROS Immunodiagnostic Products Anti-HIV 1+2 Controls are substantially equivalent to the Blackhawk BioSystems, Inc. VIROCLEAR® (BK000041), VIROTROL® I (BK920008) and VIROTROL® HIV-2 (BK920028) Controls.

 

5.  Device Description

 

The VITROS Immunodiagnostic Products Anti-HIV 1+2 Controls are assayed controls that are intended for use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic System when used for the qualitative in vitro detection of antibodies to Human Immunodeficiency Virus types 1 and/or 2 (anti-HIV 1 and anti-HIV 2) in human serum and plasma (heparin, EDTA or citrate) when using the VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack on the VITROS ECi/ECiQ Immunodiagnostic System. The performance of the VITROS Immunodiagnostic Products Anti-HIV 1+2 Controls has not been established with any other anti-HIV 1+2 assays.

The VITROS Immunodiagnostic System uses luminescence as the signal in the qualitative detection of Anti-HIV 1+2 in human serum and plasma. Coated microwells are used as the solid phase separation system.

The system is comprised of three main elements:

    • The VITROS Immunodiagnostic Products range of immunoassay products in this case the VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack, the VITROS Immunodiagnostic Products Anti-HIV 1+2 Calibrators, which are combined by the VITROS Immunodiagnostic system to perform the VITROS Anti-HIV 1+2 assay. The VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack and Calibrator have been submitted for FDA review in PMA BP050051.

       

       

    • The VITROS Immunodiagnostic System - instrumentation, which provides automated use of the immunoassay kits. The VITROS Immunodiagnostic System was cleared for market by a separate 510(k) pre-market notification (K962919).

       

       

    • Common reagents used by the VITROS System in each assay - the VITROS Immunodiagnostic Products Signal Reagent and VITROS Immunodiagnostic Products Universal Wash Reagent were cleared as part of the VITROS Immunodiagnostic Products Total T3 Reagent Pack and VITROS Immunodiagnostic Products Total T3 Calibrators 510(k) premarket notification (K964310).

       

    The VITROS System and common reagents are dedicated specifically for use only with the VITROS Immunodiagnostic Products range of immunoassay products.

    6.  Device Intended Use

     

    For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic System when used for the qualitative in vitro detection of antibodies to Human Immunodeficiency Virus types 1 and/or 2 (anti-HIV 1 and anti-HIV 2) in human serum and plasma (heparin, EDTA or citrate) when using the VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack on the VITROS ECi/ECiQ Immunodiagnostic System. The performance of the VITROS Immunodiagnostic Products Anti-HIV 1+2 Controls has not been established with any other anti-HIV 1+2 assays.

     

    7.  Comparison to Predicate Device

     

    The VITROS Immunodiagnostic Products Anti-HIV 1+2 Controls are substantially equivalent to the Blackhawk BioSystems, Inc. VIROCLEAR® (BK000041), VIROTROL® I (BK920008) and VIROTROL® HIV-2 (BK920028) Controls.

    Tables 1-3 lists the similarities and differences of the device characteristics between the VITROS Anti-HIV 1+2 Controls and the predicate devices.

    Table 1 Comparison of the VITROS Immunodiagnostic Products Anti-HIV 1+2 Negative Control to the Blackhawk Biosystems, Inc. VIROCLEAR® (BK000041) Control

    Comparison
    Device Characteristic New device Predicate device
    Intended Use

    For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic System when used for the qualitative in vitro detection of antibodies to Human Immunodeficiency Virus types 1 and/or 2 (anti-HIV 1 and anti-HIV 2) in human serum and plasma (heparin, EDTA or citrate) when using the VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack on the VITROS ECi/ECiQ Immunodiagnostic System. The performance of the VITROS Immunodiagnostic Products Anti-HIV 1+2 Controls has not been established with any other anti-HIV 1+2 assays.

     

    VIROCLEAR is intended for use as an unassayed non-reactive quality assurance reagent with in vitro assays detecting antibody to Human Immunodeficiency Virus Type 1 (anti-HIV-1), antibody to Human Immunodeficiency Virus Type 2 (anti-HIV-2), antibody to Human T-Lymphotropic Virus Type I (anti-HTLV-I), antibody to Human T-Lymphotropic Virus Type II (anti-HTLV-II), antibody to Hepatitis C Virus (anti-HCV), immunoglobulin M and total antibodies to Hepatitis B core Antigen (anti-HBc IgM and anti-HBc total), Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis B Surface Antigen (anti-HBs), immunoglobulin M and total antibody to Hepatitis A Virus (anti-HAV IgM and anti-HAV total), Hepatitis B e Antigen (HBeAg), antibody to Hepatitis B e Antigen (anti-HBe), antibody to Hepatitis Delta Virus (anti-HDV), antibody to Cytomegalovirus (anti-CMV), immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to Treponema pallidum and non-treponemal antibodies (reagin). VIROCLEAR reagents are intended to provide a means of estimating precision and have the potential for systematic deviations from specific laboratory testing procedures.

     

    Matrix Human plasma with added antimicrobial agent Human serum and proteins from human sources, antimicrobial agents as preservative and stabilizers
    Preparation for Use Freeze dried Liquid
    Control Level Negative for antibodies to HIV 1+2 Non-reactive for antibody to HIV-1, antibody to HIV-2, antibody to HTLV-I, antibody to HTLV-II, antibody to HCV, IgM and total antibodies to HBc, Hepatitis B Surface Antigen, antibody to Hepatitis B Surface Antigen, IgM and total antibodies to HAV, Hepatitis B e Antigen, antibody to Hepatitis B e Antigen, antibody to HDV, antibody to CMV, IgG and IgM antibodies toTreponema pallidum and non-treponemal antibodies (reagin).
    Expected Values Each control has a quoted mean value derived from a minimum of 10 assays and a standard deviation anticipated for single determinations of each control in a number of different laboratories using different reagent lots. Values are lot specific. As stated in the package insert, VIROCLEAR reagents do not have assigned values, it is recommended that each laboratory validate the use of each lot of VIROCLEAR with each specific assay system prior to its routine use in the laboratory.
    Table 2 Comparison of the VITROS Immunodiagnostic Products Anti-HIV 1 Positive Control to the Blackhawk Biosystems, Inc. VIROTROL® I (BK920008) Control
    Comparison
    Device Characteristic New device Predicate device
    Intended Use

    For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic System when used for the qualitative in vitro detection of antibodies to Human Immunodeficiency Virus types 1 and/or 2 (anti-HIV 1 and anti-HIV 2) in human serum and plasma (heparin, EDTA or citrate) when using the VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack on the VITROS ECi/ECiQ Immunodiagnostic System. The performance of the VITROS Immunodiagnostic Products Anti-HIV 1+2 Controls has not been established with any other anti-HIV 1+2 assays.

     

    VIROTROL I is intended for use with in vitro assay procedures for determination of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1), antibodies to Human T-Lymphotropic Virus Type I (HTLV-I), antibodies to Hepatitis C Virus (HCV), Hepatitis B Surface Antigen (HBsAg), antibodies to Hepatitis B Core Antigen (HBc) and antibodies to Cytomegalovirus (CMV). VIROTROL reagents are intended to provide a means of estimating precision and have the potential for systematic deviations from specific laboratory testing procedures.

     

    Matrix Human plasma with added antimicrobial agent Human serum reactive for antibody to HIV-1, antibody to HTLV-I, antibody to HCV, antibody to HBc, antibody CMV, and HBsAg. VITROTROL I contains proteins from human and bovine sources, antimicrobial agents as preservative, and stabilizers.
    Preparation for Use Freeze dried Liquid
    Control Level Positive for antibody to HIV-1 Reactive for antibody to HIV-1, antibody to HTLV-I, antibody to HCV, antibody to HBc, antibody to CMV, and HBsAg.
    Expected Values Each control has a quoted mean value derived from a minimum of 10 assays and a standard deviation anticipated for single determinations of each control in a number of different laboratories using different reagent lots. Values are lot specific. As stated in the package insert, VIROTROL reagents do not have assigned values, it is recommended that each laboratory validate the use of each lot of VIROTROL with each specific assay system prior to its routine use in the laboratory.
    Table 3 Comparison of the VITROS Immunodiagnostic Products Anti-HIV 2 Positive Control to the Blackhawk Biosystems, Inc. VIROTROL® HIV-2 (BK920028) Control
    Comparison
    Device Characteristic New device Predicate device
    Intended Use

    For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic System when used for the qualitative in vitro detection of antibodies to Human Immunodeficiency Virus types 1 and/or 2 (anti-HIV 1 and anti-HIV 2) in human serum and plasma (heparin, EDTA or citrate) when using the VITROS Immunodiagnostic Products Anti-HIV 1+2 Reagent Pack on the VITROS ECi/ECiQ Immunodiagnostic System. The performance of the VITROS Immunodiagnostic Products Anti-HIV 1+2 Controls has not been established with any other anti-HIV 1+2 assays.

     

    VIROTROL HIV-2 is intended for use as an unassayed reactive control with in vitro assay procedures for determination of antibodies to Human Immunodeficiency Virus Type 2 (HIV-2). VIROTROL HIV-2 reagents are intended to provide a means of estimating precision and have the potential for systematic deviations from specific laboratory testing procedures
    Matrix Human plasma with added antimicrobial agent Human serum reactive for antibody to HIV-2, proteins from human sources, antimicrobial agents as preservatives and stabilizers.
    Preparation for Use Freeze dried Liquid
    Control Level Positive for antibody to HIV-2 Positive for antibody to HIV-2
    Expected Values Each control has a quoted mean value derived from a minimum of 10 assays and a standard deviation anticipated for single determinations of each control in a number of different laboratories using different reagent lots. Values are lot specific. As stated in the package insert, VIROTROL reagents do not have assigned values, it is recommended that each laboratory validate the use of each lot of VIROTROL with each specific assay system prior to its routine use in the laboratory.

     

    8.  Conclusions

     

    The data presented in the premarket notification demonstrates that the VITROS Anti-HIV 1+2 Controls are safe and effective for their stated intended use and are substantially equivalent to the cleared predicate devices.

    The VITROS Immunodiagnostic Products Anti-HIV 1+2 Controls were compared to the Blackhawk Biosystems, Inc. VIROCLEAR® (BK000041) Control, VIROTROL® I (BK920008) Control and VIROTROL® HIV-2 (BK920028) Control.