ELVIS HSV GOLD

K960578 · Diagnostic Hybrids, Inc. · GQN · Sep 5, 1996 · Microbiology

Device Facts

• Record ID: K960578
• Device Name: ELVIS HSV GOLD
• Applicant: Diagnostic Hybrids, Inc.
• Product Code: GQN · Microbiology
• Decision Date: Sep 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3305
• Device Class: Class 2

Intended Use

The Test Kit provides the cells and reagents necessary for detection and identification of HSV in patient specimens.

Device Story

ELVIS™ HSV GOLD utilizes mixed cell monolayer (MRC-5 and genetically modified Baby Hamster Kidney cells) to detect HSV-1/2. Patient specimens inoculated into cell culture; HSV infection triggers intracellular production of bacterial enzyme beta-galactosidase. Monolayers examined daily for cytopathic effect (CPE). If CPE observed, cells fixed and stained; presence of blue cells indicates HSV-positive result. If no CPE by day 7, cells stained to detect pre-CPE blue cells. Used in clinical laboratories; performed by laboratory technicians. Output is visual identification of blue-stained cells via light microscopy. Confirms HSV presence; facilitates clinical diagnosis of viral infection.

Clinical Evidence

Clinical study across 4 laboratories with >670 specimens. Compared against standard tube culture methods. Reported clinical sensitivity 98.1% and clinical specificity 98.7%.

Technological Characteristics

Mixed cell monolayer (MRC-5 human fetal lung cells and genetically modified Baby Hamster Kidney cells). Detection principle: HSV-induced beta-galactosidase enzyme expression. Visualization: Light microscopy. Signal: Blue colorimetric staining. No software or electronic components.

Indications for Use

Indicated for detection and identification of Herpes simplex virus (HSV-1 and HSV-2) in clinical patient specimens submitted for viral testing.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Standard Tube Culture

Submission Summary (Full Text)

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K960578

SEP 5 1996

510(k) Summary

Page 1 of 2

a.1. Diagnostic Hybrids, Inc.
1 President Street
Athens, Oh 45701
[phone]
Attn: J.L. Brown
Date of Preparation: February 1, 1996

a.2. Trade Name: ELVIS™ HSV GOLD
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.

a.6. A comparison of the technological characteristics:

| | 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 |

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Diagnostic Hybrids, Inc.
Athens, Ohio
510(k) Summary
Page 2 of 2

b.1. The non-clinical tests consist of those directed at defining the shelf life of the test kit components, the analytical sensitivity and the specificity of the test kit.

b.2. The clinical tests submitted consist of 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 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. The above test results demonstrate that the ELVIS™ HSV GOLD 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.