← Product Code [LIN](/submissions/MI/subpart-d%E2%80%94serological-reagents/LIN) · K951821 # CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (K951821) _Light Diagnostics · LIN · Jun 7, 1996 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LIN/K951821 ## Device Facts - **Applicant:** Light Diagnostics - **Product Code:** [LIN](/submissions/MI/subpart-d%E2%80%94serological-reagents/LIN.md) - **Decision Date:** Jun 7, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.3175 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## Indications for Use The Light Diagnostics Cytomegalovirus Direct Immunofluorescence Assay is intended for use in centrifugation enhanced shell vials in the qualitative detection and identification of immediate early antigen- of human CMV. ## Device Story Direct immunofluorescence assay (DFA) for culture confirmation of Cytomegalovirus (CMV). Input: tissue culture cells from clinical specimen inoculum on slide substrate. Principle: detector mouse monoclonal antibody conjugated to fluorescein isothiocyanate (FITC) binds to 68-72 kDa immediate early (IE) non-structural CMV antigen. Output: visualization of antigen-antibody complex via fluorescence microscopy. Used in clinical laboratories by trained technicians. Provides rapid identification of CMV in shell vial cultures; aids clinical diagnosis of viral infection. ## Clinical Evidence Clinical evaluation compared subject device to indirect immunofluorescence tests using 516 specimens. Results showed sensitivity (95% CI) of 82.5% to 98.7% and specificity (95% CI) of 97.2% to 99.5%. ## Technological Characteristics Direct immunofluorescence assay. Detector: mouse monoclonal antibody specific for 68-72 kDa immediate early (IE) CMV antigen, conjugated to fluorescein isothiocyanate (FITC). Substrate: tissue culture cells on slides. Detection method: fluorescence microscopy. ## Regulatory 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 - Light Diagnostics Cytomegalovirus Immunofluorescence Assay - Light Diagnostics Cytomegalovirus Pre-CPE Culture Identification Test - Syva MicroTrak CMV Culture Identification Test ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K951821 JUN - 7 1996 # 510(k) SUMMARY 1. 510(k) Contact Person: Dale Dembrow *Light Diagnostics* (909) 676-8080 28835 Single Oak Drive Extension 230 Temecula, California 92590 2. Device: *Light Diagnostics* Cytomegalovirus Direct Immunofluorescence Assay A direct immunofluorescence assay for the identification of Cytomegalovirus 3. Substantial Equivalence to: *Light Diagnostics* Cytomegalovirus Immunofluorescence Assay Cytomegalovirus Pre-CPE Culture Identification Test Syva MicroTrak CMV Culture Identification Test For pre-CPE and CPE applications 4. Device Description: *Light Diagnostics* Cytomegalovirus Direct Immunofluorescence Assay (CMV DFA) uses the standard laboratory direct immunofluorescence technique for the culture confirmation of cytomegalovirus. The DFA is based on the principle of antigen identification using a detector monoclonal antibody conjugated to fluorescein isothiocyanate. The substrate consists of a slide prepared from the tissue cultured cells from a clinical specimen inoculum. Anti CMV FITC labeled antibody is applied to the substrate. The antibody will bind to specific antigen, if present, in the substrate. The fluorescein conjugated monoclonal antibody allows for visualization of the antigen / antibody complex by fluorescence microscopy. {1} # 510(k) SUMMARY Mouse monoclonal antibody is used as the detector antibody in *Light Diagnostics* Cytomegalovirus Direct Immunofluorescence Assay. The use of monoclonal antibody ensures increased specificity and reduced non-specific interference. The monoclonal antibody is specific for a 68-72 kDa non-structural protein designated as immediate early (IE) antigen of human CMV. 5. Intended Use: The *Light Diagnostics* Cytomegalovirus Direct Immunofluorescence Assay is intended for use in centrifugation enhanced shell vials in the qualitative detection and identification of immediate early antigen- of human CMV. 6. Technological Characteristics Comparison of *Light Diagnostics* Cytomegalovirus Direct Immunofluorescence Assay and other legally marketed *in vitro* diagnostic kits for detection and identification of CMV. a. Principle: All kits use standard immunofluorescence assay techniques on cell substrate slides obtained after processing specimens for viral isolation in tissue culture. b. Materials: All kits incorporate monoclonal antibody specific for CMV as the detector antibody. ## Performance Data for Light Diagnostics Cytomegalovirus Direct Immunofluorescence Assay Kit 1. Nonclinical evaluation: The conjugated monoclonal antibody used in the kit was characterized for its ability to detect Cytomegalovirus. The anti CMV antibody reacted appropriately when tested with reference virus strains and clinical isolates. The conjugated monoclonal antibody was evaluated for cross reactivity to a variety of viral pathogens and host cell controls. No discordant results were obtained. The monoclonal antibody was evaluated for cross reactivity to a variety of microorganisms. No cross reactions were observed. {2} # 510(k) SUMMARY 2. Clinical Evaluation: *Light Diagnostics* Cytomegalovirus Direct Immunofluorescence Assay was compared in clinical evaluation to indirect immunofluorescence tests for detection and identification of CMV. Five hundred and sixteen specimens were evaluated with results for 95% confidence interval sensitivity of 82.5% to 98.7% and specificity of 97.2% to 99.5%. 3. Conclusions Drawn from Evaluations: *Light Diagnostics* Cytomegalovirus Direct Immunofluorescence Assay Kit uses the standard laboratory DFA in the culture confirmation of cytomegalovirus. The monoclonal antibody used in the kit has been extensively characterized to ensure maximum specificity and reliability. In clinical evaluations, the kit performed comparably with results obtained by indirect immunofluorescence. Extensive characterization and clinical evaluation of *Light Diagnostics* Cytomegalovirus Direct Immunofluorescence Assay verifies its safety and effectiveness when used as intended. --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LIN/K951821](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LIN/K951821) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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