HERPES GROUP IGG

K033059 · Trinity Biotech, Inc. · LGC · Nov 26, 2003 · Microbiology

Device Facts

• Record ID: K033059
• Device Name: HERPES GROUP IGG
• Applicant: Trinity Biotech, Inc.
• Product Code: LGC · Microbiology
• Decision Date: Nov 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3305
• Device Class: Class 2

Indications for Use

The Trinity Biotech Captia™ Herpes Group IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative determination of IgG antibodies in human serum to Herpes simplex virus. The Herpes Group IgG ELISA kit may be used to determine serologic status in females of child bearing age, and to evaluate paired sera for the presence of a seroconversion of IgG as an aid in the diagnosis of Herpes simplex virus infection. It is not intended for determining the type of Herpes simplex virus.

Device Story

The Captia Herpes Group IgG ELISA is an in vitro diagnostic test for human serum. It utilizes purified Herpes Group antigen immobilized on microtiter wells. Patient serum is added; if specific IgG antibodies are present, they bind to the antigen. After washing, enzyme-labeled anti-human IgG is added, followed by a substrate solution. The resulting color change is measured photometrically, providing an indirect quantitative measurement of antibody concentration. The test is performed in clinical laboratories by trained personnel. Results assist clinicians in assessing serologic status and identifying seroconversion in patients suspected of acute infection. It does not differentiate between HSV-1 and HSV-2.

Clinical Evidence

No clinical data provided. Device is a distributor change; performance characteristics were established in the predicate device (K963645).

Technological Characteristics

Enzyme-Linked Immunosorbent Assay (ELISA) using purified Herpes Group antigen immobilized on solid-phase microtiter wells. Employs enzyme-labeled anti-human IgG conjugate and substrate for colorimetric detection. Photometric measurement of optical density. Manual or automated microplate processing. Standard laboratory equipment required.

Indications for Use

Indicated for qualitative determination of IgG antibodies to Herpes simplex virus in human serum. Used to determine serologic status in females of child-bearing age and to evaluate paired sera for IgG seroconversion as an aid in diagnosis. Not intended for HSV typing.

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

• Herpes Group IgG ELISA Test System (K963645)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K033059

B. Analyte:
Herpes simplex virus

C. Type of Test:
Enzyme-Linked Immunosorbent Assay

D. Applicant:
Trinity Biotech USA

E. Proprietary and Established Names:
Trinity Biotech Captia Herpes Group IgG Enzyme-Linked Immunosorbent Assay

F. Regulatory Information:
1. Regulation section:
866.3305
2. Classification:
Class III
3. Product Code:
LGC
4. Panel:
83

G. Intended Use:
1. Intended use(s):
The Trinity Biotech Captia Herpes Group IgG Enzyme-Linked Immunosorbent Assay (ELISA) is intended for the qualitative determination of IgG antibodies in human serum to Herpes simplex virus. The Herpes Group IgG ELISA kit may be used to determine serologic status in females of child bearing age, and to evaluate paired sera for the presence of seroconversions of IgG as an aid in the diagnosis of Herpes simplex virus infection.
2. Indication(s) for use:
The Herpes IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative determination of IgG antibodies in human serum to Herpes simplex virus. The Herpes Group IgG ELISA kit may be used to determine serologic status in females of child bearing age, and to evaluate paired sera for the presence of a seroconversion of IgG as an aid in the

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diagnosis of Herpes simplex virus infection. It is not intended for determining the type of Herpes simplex virus.

3. Special condition for use statement(s):
Not Applicable

4. Special instrument Requirements:
Single or dual wavelength microplate reader with 450 nm filter

## H. Device Description:

This is an ELISA kit that contains Herpes simplex virus (MacIntyre strain, Vero cell Propagated virus is harvested by disrupting the cells, pelleted and solubilized) antigen coated microassay plate in a 96 well configuration, serum diluent, cutoff calibrator, a high positive, low positive, and negative control, horseradish-peroxidase conjugate, Chromogen/substrate solution, wash buffer and stop solution.

## I. Substantial Equivalence Information:

1. Predicate device name(s):
Herpes Group IgG ELISA Test System

2. Predicate K number(s):
K963645

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Detect H. pylori IgG antibodies in human serum | Detect H. pylori IgG antibodies in human serum |
| Reagents | Tris BSA Serum Diluent Tris Tween Wash Buffer Goat anti-human IgG (Fc) | Tris BSA Serum Diluent Tris Tween Wash Buffer Goat anti-human IgG (Fc) |
| Technology | ELISA | ELISA |
| Reagents | Horseradish Peroxidase Conjugate TMB enzyme substrate Sulfuric Acid Stop | Horseradish Peroxidase Conjugate TMB enzyme substrate Sulfuric Acid Stop |
| Procedure | Serum incubation-20 min Conjugate incubation-20min Substrate incubation-10min Stop-add 100μl of stop solution Read at 450nm | Serum incubation-20 min Conjugate incubation-20min Substrate incubation-10min Stop-add 100μl of stop solution Read at 450nm |
| Calculations | 1 cutoff calibrator, high, low, and negative controls Multiply cutoff calibrator by correction factor | 1 cutoff calibrator, high, low, and negative controls Multiply cutoff calibrator by correction factor |
| Differences | | |
| Item | Device | Predicate |
| None | None | None |

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J. Standard/Guidance Document Referenced (if applicable):
Not Applicable

K. Test Principle:
Enzyme-Linked Immunosorbent Assays (ELISA) rely on the ability of biological materials, (i.e. antigens) to adsorb to plastic surfaces such as polystyrene (solid phase). When antigens bound to the solid phase are brought into contact with a patient's serum, antigen specific antibody, if present, will bind to the antigen on the solid phase forming antigen-antibody complexes. Excess antibody is removed by washing. This is followed by the addition of goat anti-human IgG conjugated with horseradish peroxidase which then binds to the antibody-antigen complexes. The excess conjugate is removed by washing, followed by the addition of Chromogen/Substrate Tetramethylbenzidine (TMB). If specific antibody to the antigen is present in the patient's serum, a blue color develops. When the enzymatic reaction is stopped with 1N H2SO4, the contents of the wells turn yellow. The color, which is proportional to the concentration of antibody in the serum, can be read on a suitable spectrophotometer or ELISA microwell plate reader.

L. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
Not Applicable. This is a change in the distributor only. The performance characteristics were established in K963645.
b. Linearity/assay reportable range:
Not Applicable
c. Traceability (controls, calibrators, or method):
Not Applicable
d. Detection limit:
Not Applicable
e. Analytical specificity:
Not Applicable
f. Assay cut-off:
Not Applicable

2. Comparison studies:
a. Method comparison with predicate device:
Not Applicable
b. Matrix comparison:
Not Applicable

3. Clinical studies:
a. Clinical sensitivity:
Not Applicable
b. Clinical specificity:
Not Applicable
c. Other clinical supportive data (when a and b are not applicable):
Not Applicable

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4. Clinical cut-off:
Not Applicable

5. Expected values/Reference range:
Not Applicable

**M. Conclusion:**
The Trinity Biotech Captia Herpes Group IgG ELISA is substantially equivalent in performance to the predicate device for the identification of Herpes Simplex Virus in human serum.