(206 days)
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No
The device description details a biological assay based on cell culture and enzymatic detection, with no mention of computational analysis, algorithms, or machine learning.
No
This device is a diagnostic test kit used for the detection and identification of HSV, not for treating or preventing a disease.
Yes
The "Intended Use / Indications for Use" section states that the kit is for "detection and identification of HSV in patient specimens," and the "Device Description" details how it is used to confirm positive or negative results for HSV. This clearly indicates a diagnostic purpose.
No
The device description clearly outlines a physical test kit containing cells and reagents, which are hardware components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the kit is for the "detection and identification of HSV in patient specimens." This is a classic definition of an in vitro diagnostic test, as it analyzes biological samples (patient specimens) outside of the body to diagnose a condition (HSV infection).
- Device Description: The description details a process of analyzing patient specimens using cells and reagents to detect the presence of a specific marker (beta-galactosidase induced by HSV). This process is performed in vitro (in a lab setting).
- Intended User / Care Setting: The intended users are "clinical laboratories," which are the typical settings where IVD tests are performed.
- Performance Studies: The document describes clinical studies performed on patient specimens to evaluate the performance (sensitivity and specificity) of the test. This is a standard requirement for demonstrating the effectiveness of an IVD.
- Comparison to Predicate: The comparison to "Classical 'Gold' standard tube culture methods" further reinforces that this device is intended to perform a diagnostic function similar to established IVD methods.
The device fits the definition of an IVD because it is a medical device intended to be used in vitro for the examination of specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Test Kit provides the cells and reagents necessary for detection and identification of HSV in patient specimens.
Product codes
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Device Description
The subject device consists of a mixed cell monolayer comprised of MRC-5 (Human Fetal Lung) and genetically modified Baby Hamster Kidney Cells (ELVIS™ HSV cells) which, when infected with HSV-1 or -2, are activated to produce and accumulate intracellularly the bacterial enzyme, beta-galactosidase. As in standard tube culture procedures, inoculated monolayers are examined daily for CPE. When CPE is observed, the monolayers are fixed and stained for the presence of beta-galactosidase. If blue cells are detected, indicating the presence of the enzyme which was induced by HSV, then the specimen is confirmed as being positive for HSV. If CPE is not detected by day 7 after inoculation, the monolayers are stained for the presence of pre-CPE, blue, HSV-infected cells. If none are found, the specimens are negative for HSV.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
The clinical tests submitted consist of studies performed in 4 different laboratories on over 670 different specimens. The specimens tested were those normally submitted to the respective institution for HSV testing; ELVIS™ HSV GOLD testing was performed on those specimens for which there was sufficient residual sample.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests: defining the shelf life of the test kit components, the analytical sensitivity and the specificity of the test kit.
Clinical tests: studies performed in 4 different laboratories on over 670 different specimens. The overall results show for the ELVIS™ HSV GOLD test a clinical sensitivity of 98.1% and a clinical specificity of 98.7% compared to the predicate tests. The results from the clinical tests of ELVIS™ HSV GOLD , as well as the users' experience with the Test demonstrate that the device is safe and effective and performs at a level that is substantially equivalent to the predicate devices and standard clinical test methods employed at each Site.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical sensitivity of 98.1% and a clinical specificity of 98.7%.
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.3305 Herpes simplex virus serological assays.
(a)
Identification. Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.(b)
Classification. Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).
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510(k) Summary Page 1 of 2
- a.l. Diagnostic Hybrids, Inc. l President Street Athens. Oh 45701 (614) 593-1784 Attn: J.L. Brown Date of Preparation: February 1, 1996
- ELVISTM HSV GOLD a.2. Trade Name: Common Name: Enzyme Linked Virus Inducible System Tube Culture for Herpes simplex virus isolation and identification. Classification Name: Not known.
- a.3. Classical "Gold" standard tube culture methods commonly used by many clinical laboratories for isolation and identification of HSV. Confirmation, where used, is by fluorescent antibodies directed against HSV antigens.
- a.4. The subject device consists of a mixed cell monolayer comprised of MRC-5 (Human Fetal Lung) and genetically modified Baby Hamster Kidney Cells (ELVIS™ HSV cells) which, when infected with HSV-1 or -2, are activated to produce and accumulate intracellularly the bacterial enzyme, beta-galactosidase. As in standard tube culture procedures, inoculated monolayers are examined daily for CPE. When CPE is observed, the monolayers are fixed and stained for the presence of beta-galactosidase. If blue cells are detected, indicating the presence of the enzyme which was induced by HSV, then the specimen is confirmed as being positive for HSV. If CPE is not detected by day 7 after inoculation, the monolayers are stained for the presence of pre-CPE, blue, HSV-infected cells. If none are found, the specimens are negative for HSV.
- a.5. Intended Use: The Test Kit provides the cells and reagents necessary for detection and identification of HSV in patient specimens.
| Predicate devices | Subject device | |
|---|---|---|
| Characteristics | Standard Tube Culture | ELVISTM HSV GOLD |
| In situ detection: | Yes | Yes |
| Positive result | ||
| indicated by: | CPE, confirmed by | |
| Fluorescent Cells | CPE, confirmed by | |
| Blue Colored Cells | ||
| Detection by: | Fluorescence Microscope | Light Microscope |
| Signal generated by: | Fluorescence | Beta-Galactosidase |
a.6. A comparison of the technological characteristics:
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Diagnostic Hybrids, Inc. Athens, Ohio
510(k) Summary Page 2 of 2
- The non-clinical tests consist of those directed at defining the b.1. shelf life of the test kit components, the analytical sensitivity and the specificity of the test kit.
- The clinical tests submitted consist of studies performed in 4 b.2. different laboratories on over 670 different specimens. The overall results show for the ELVIS™ HSV GOLD test a clinical sensitivity of 98.1% and a clinical specificity of 98.7% compared to the predicate tests. The specimens tested were those normally submitted to the respective institution for HSV testing; ELVIS™ HSV GOLD testing was performed on those specimens for which there was sufficient residual The above test results demonstrate that the ELVIS™ HSV GOLD sample. test is substantially equivalent to the predicate tests.
- b.3. The results from the clinical tests of ELVIS™ HSV GOLD , as well as the users' experience with the Test demonstrate that the device is safe and effective and performs at a level that is substantially equivalent to the predicate devices and standard clinical test methods employed at each Site.