(414 days)
Light Diagnostics Cytomegalovirus Immunofluorescence Assay, Cytomegalovirus Pre-CPE Culture Identification Test, Syva MicroTrak CMV Culture Identification Test
No
The device description details a standard immunofluorescence assay technique using monoclonal antibodies and fluorescence microscopy for visualization. There is no mention of automated image analysis, pattern recognition, or any computational methods that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
This device is a diagnostic assay for detecting CMV antigen, not for treating any condition.
Yes
The device is used for the qualitative detection and identification of an antigen, which is a diagnostic purpose to identify the presence of human CMV.
No
The device description clearly outlines a laboratory assay using antibodies, fluorescence microscopy, and tissue culture cells, indicating a physical kit and laboratory procedures, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection and identification of immediate early antigen- of human CMV" using a laboratory assay. This is a classic definition of an in vitro diagnostic test.
- Device Description: The description details a laboratory technique (direct immunofluorescence) that analyzes a biological sample (tissue cultured cells from a clinical specimen) to detect a specific analyte (CMV antigen). This process is performed outside of the body (in vitro).
- Input Imaging Modality: Fluorescence microscopy is used to visualize the results of the assay, which is a common method in IVD testing.
- Intended User / Care Setting: The intended user is a "Standard laboratory," which is where IVD tests are typically performed.
The information provided clearly indicates that this device is designed to be used in a laboratory setting to diagnose or detect a condition (CMV infection) by examining a sample taken from the human body. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
Not Found
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 laheled 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 flucrescence microscopy.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical evaluation:
The conjugated monoclonal antibody used in the kit was characterized for its ability to detect Cytomegalovinus. 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.
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%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity of 82.5% to 98.7%, Specificity of 97.2% to 99.5%
Predicate Device(s)
Substantial Equivalence to: Light Diagnostics Cytomegalovirus Immunofluorescence Assay, Cytomegalovirus Pre-CPE Culture Identification Test, Syva MicroTrak CMV Culture Identification Test
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K951821 u
-7 1996
510(k) SUMMARY
- 510(k) Light Diagnostics 28835 Single Oak Drive Temecula, California 92590
Contact Person: Dale Dembrow (909) 676-8080 Extension 230
- Device: 2. Light Diagnostics Cytomegalovirus Direct Immunofluorescence Assav A direct immunofluorescence assay for the identification of Cytomegalovirus
- Substantial Equivalence to: 3.
Light Diagnostics Cytomegalovirus Immunofluorescence Assay Cytomegalovirus Pre-CPE Culture Identification Test
Syva MicroTrak CMV Culture Identification Test For pre-CPE and CPE applications
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- 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 laheled 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 flucrescence microscopy.
- Device Description:
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.
- Intended Use: ട്.
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ﺎﺭ ﺍﻟﻤﺴﺎﺑﻘﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍ
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.
- Technological Characteristics Comparison of Light Diagnostics 6. Cytomegalovirus Direct Immunofluorescence Assay and other legally marketed in vitro diagnostic kits for detection and identification of CMV.
- All kits use standard immunofluorescence assay Principle: a. 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
- Nonclinical evaluation: 1.
The conjugated monoclonal antibody used in the kit was characterized for its ability to detect Cytomegalovinus. 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.
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2
510(k) SUMMARY
Clinical Evaluation: ' 2.
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%.
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.
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