IMMULITE TOXOPLASMA QUANTITATIVE IGG

{0} Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045-5597 Tel: (213) 776-0180 Fax: (213) 776-0204 K962936 APR 24 1997 # 510(k) Summary ## Safety and Effectiveness **IPC®** This summary of 510(k) safety and effectiveness information is being submitted 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:** | (213) 776-0180 | | **Facsimile Number:** | (213) 776-0280 | | **Contact Person:** | Edward M. Levine, Ph.D. Manager of Clinical Affairs | | **Date of Preparation:** | July 25, 1996 | | **Device Name:** | | | **Proprietary Name:** | IMMULITE® Toxoplasma Quantitative IgG | | **Catalog Number:** | LKTXQ1 (100 tests); LKTXQ5 (500 tests) | | **Common:** | Reagent system for the determination of Toxoplasma gondii IgG antibodies in human serum. Class II device (866.3780) | | **Classification:** | | | **Manufacturer:** | Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597 | | **Establishment Registration #:** | DPC's Registration # is 2017183 | | **Substantially Equivalent Predicate Device:** | bioMérieux Vitek VIDAS® Toxo IgG Abbott Laboratories IMx® Toxo IgG | | **Description of Device:** | IMMULITE Toxoplasma Quantitative IgG is a clinical device for use with the IMMULITE Automated Immunoassay Analyzer. | | **Intended Use of the Device:** | IMMULITE Toxoplasma Quantitative IgG is designed for the quantitative detection of IgG antibodies to Toxoplasma gondii in human serum and is intended strictly for in vitro diagnostic use as an aid in the determination of serological status to Toxoplasma gondii. | ## Summary and Explanation of the Device: **IMMULITE® Toxoplasma Quantitative IgG** is a solid-phase, two-step, chemiluminescent enzyme immunoassay. The solid phase, a polystyrene bead enclosed within an IMMULITE® Test Unit, is coated with a partially purified Toxoplasma gondii antigen, strain RH. Prediluted patient sample (1-in-21 dilution) and a protein-based buffer are simultaneously introduced into the Test Unit, and incubated for approximately 30 minutes at 37°C with intermittent {1} Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597 IMMULITE® Toxoplasma Quantitative IgG 510(k) Summary of Safety and Effectiveness Page 2 of 2 ## Summary and Explanation of the Device (continued): agitation. During this time, toxoplasma IgG in the sample binds to the toxoplasma antigen-coated bead. Unbound serum is then removed by a centrifugal wash. An alkaline phosphatase-labeled anti-human IgG antibody is introduced, and the Test Unit 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 is incubated for an additional 10 minutes. 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 the photon output, as measured by the luminometer - is directly related to the quantity of toxoplasma IgG in the sample. A quantitative result in IU/mL is then obtained by comparing the patient result to a stored Master Curve, and which is adjusted to the response of each analyzer. ## Summary of Studies: The clinical performance of the IMMULITE Toxoplasma IgG procedure was compared to the VIDAS® and IMx® Toxoplasma IgG assays, using a total of 199 serum specimens. A summary of the results is shown in the table below. | | IMMULITE vs. VIDAS® | IMMULITE vs. IMx® | | --- | --- | --- | | Agreement | 99.0% | 96.4% | | Sensitivity | 96.3% | 90.2% | | Specificity | 100.0% | 98.6% | | n= | 199 | 194 | ## Conclusion: The conclusions drawn from the clinical and nonclinical studies demonstrate that the device is safe, effective, and performs as well as, or better, than the current legally marketed devices.