K Number

Device Name

HERPES GROUP IGG ELISA TEST SYSTEM

Manufacturer

ARMKEL, LLC.

Date Cleared

1997-02-04

(145 days)

Product Code

LGC

Regulation Number

866.3305

Intended Use

The 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 evaluate paired sera for the presence seroconversions of IgG as an aid in the diagnosis of Herpes simplex virus infection.

Device Description

The Herpes Group IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Herpes simplex virus. Purified Herpes Group antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

More Information

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Expedited Review

Predicate Devices

Clarks HSV I and HSV II ELISA tests.

Reference Devices

Clarks HSVI,HSVII

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a standard ELISA assay which relies on chemical reactions and photometric measurement, with no mention of computational analysis or algorithms that would suggest AI/ML. The performance studies focus on traditional metrics like sensitivity and specificity, not metrics typically associated with AI/ML model evaluation (e.g., AUC, MRMC). There is no mention of training or test sets for an algorithm.

Therapeutic

No
The device is an in-vitro diagnostic (IVD) kit used to detect antibodies for diagnostic purposes, not to treat a disease or condition.

Diagnostic

Yes

The intended use explicitly states the kit "may be used to evaluate paired sera for the presence seroconversions of IgG as an aid in the diagnosis of Herpes simplex virus infection."

SaMD (Software as a Medical Device)

The device description clearly outlines a physical ELISA kit with reagents, microtiter wells, and a photometric measurement step, indicating it is a hardware-based diagnostic test, not software only.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it is for the "qualitative determination of IgG antibodies in human serum to Herpes simplex virus" and "may be used to evaluate paired sera for the presence seroconversions of IgG as an aid in the diagnosis of Herpes simplex virus infection." This clearly indicates the device is used to examine specimens derived from the human body (serum) to provide information for diagnostic purposes.
Device Description: The description details a laboratory test (ELISA) performed on a human specimen (diluted test sera) to detect the presence of specific antibodies. This is a hallmark of an in vitro diagnostic test.
Performance Studies: The performance studies describe testing the device with human serum samples and comparing the results to other diagnostic tests (Clarks HSV I and HSV II ELISA assays and CF). This further confirms its use in a diagnostic context.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

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Device Description

Mentions image processing

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Mentions AI, DNN, or ML

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Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

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

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Summary of Performance Studies

Relative sensitivity and specificity: Four different sites compared the Wampole Herpes Group IgG ELISA test relative to Clarks HSVI and HSVII ELISA assays.
- Study 1 (R&D laboratory, Maryland): Frozen sera from normals aged 12-83, various gender, geographical areas. Total samples: 187. Relative Sensitivity = 99.1% (95% CI: 97.2% - 100%), Relative Specificity = 94.7% (95% CI: 89.6% - 99.9%), Relative Agreement = 97.2% (95% CI: 94.8% - 99.7%). Equivocals not included in calculations.
- Study 2 (R&D laboratory, New York): Frozen sera from normals aged 17-59, various gender, geographical areas. Total samples: 152. Relative Sensitivity = 97.9% (95% CI: 94.9% - 100%), Relative Specificity = 100% (95% CI: 94.2% - 100%), Relative Agreement = 98.6% (95% CI: 96.7% - 100%). Equivocals not included in calculations.
- Study 3 (clinical laboratory, Pennsylvania): Prospective samples for Herpes antibody testing. Total samples: 176. Relative Sensitivity = 99.1% (95% CI: 97.4% - 100%), Relative Specificity = 94.7% (95% CI: 88.8% - 100%), Relative Agreement = 97.7% (95% CI: 95.3% - 100%). Equivocals not included in calculations.
- Study 4 (clinical laboratory, Wisconsin): Frozen random normal samples. Total samples: 88. Relative Sensitivity = 100.0% (95% CI: 95.3% - 100%), Relative Specificity = 96.2% (95% CI: 96.2% - 100%), Relative Agreement = 98.9% (95% CI: 98.9% - 100%). Equivocals not included in calculations.
- Combined Results (Table 5): Total samples: 603. Relative Sensitivity = 98.9% (95% CI: 97.9% - 100%), Relative Specificity = 96.7% (95% CI: 94.2% - 99.1%), Relative Agreement = 98.1% (95% CI: 97.0% - 99.2%). Equivocals not included in calculations.
Precision: Seven sera were assayed ten times each on three different assays at three different sites. Intersite precision shown in Table 6. User should obtain precision of

Regulation Number and Section

§ 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).

Summary

KA63645

FEB - 4 1997

Summary of Safety and Effectiveness Information Herpes Group IgG ELISA Test Kit

I. Immuno Probe Inc. 1306 Bailes Lane, Suite F Frederick, Maryland 21701 Contact person: William Boteler Telephone: 301-695-7920 Date of preparation: Jan 23, 1997

Description of Device II.

III. Predicate Device

The Herpes Group IgG ELISA test is substantially equivalent to Clarks HSV I and HSV II ELISA tests. Equivalence is demonstrated by the following comparative results:

Performance Characteristics

Relative sensitivity and specificity. Four different sites compared the Wampole Herpes Group IgG ELISA test relative to Clarks HSVI and HSVII ELISA assays. The first site was a R&D laboratory at a commercial company located in Maryland. The frozen sera were from normals with ages from 12-83, with various gender, and geographical areas. The results of the study are compiled and summarized in Table 1.

Note: Please be advised the "refers to the comparison of this assay's results to that of a similar assay. There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison assay's accuracy to predict disease.

Table 1 Comparison of Herpes Group IgG ELISA and Clark HSV 1 and HSV 2 Study 1

Wampole Herpes Group IgG ELISA

	+	eq	-		Total
	+*	104	1	1	106
Clark
HSV 1 &
HSV 2	eq**	3	0	0	3
	_***	4	2	72	78
	Total	111	3	73	187

Relative Sensitivity = 104/105 = 99.1%	95% Confidence interval = 97.2% - 100%
Relative Specificity = 72/76 = 94.7%	95% Confidence interval = 89.6% - 99.9%
Relative Agreement = 176/181 = 97.2%	95% Confidence interval = 94.8% - 99.7%

Equivocals were not included in the above calculations. The 95% confidence intervals were calculated using the normal method.

Indicates positive on Clark HSV 1 and/or Clark HSV 2.

** Indicates equivocal on Clark HSV 1 and/or Clark HSV 2.

The second site was a R&D laboratory at a commercial company located in New York. The frozen sera were from normals with ages from 17-59, with various gender, and geographical areas. The results of the study are compiled and summarized in Table 2.

Table 2 Comparison of Herpes Group IgG ELISA and Clark HSV 1 and Clark HSV 2 Study 2

	+	eq	-	Total
+*	92	6	2	100
Clark
HSV 1 and
HSV 2	eq**	1	0	0	1
	***	0	0	51	51
	Total	93	6	53	152

Wampole Herpes Group IgG ELISA

Relative Sensitivity = 92/94 = 97.9%	95% Confidence interval = 94.9% - 100%
Relative Specificity = 51/51 = 100%	95% Confidence interval = 94.2% - 100%
Relative Agreement = 143/145 = 98.6%	95% Confidence interval = 96.7% - 100%

Equivocals were not included in the above calculations.

The 95% confidence intervals were calculated using the normal method.

The 95% confidence interval for specificity was calculated assuming one false positive.

Indicates positive on Clark HSV 1 and/or Clark HSV 2.

** Indicates equivocal on Clark HSV 1 and/or Clark HSV 2.

The third site was a clinical laboratory located in Pennsylvania. The sera were prospective samples sent in to the lab for Herpes antibody testing. The results of the studies are compiled and summarized in Table 3.

Table 3 Comparison of Herpes Group IgG ELISA and Clark HSV 1 and Clark HSV 2 Study 3

	+	eq	-	Total
+*	112	0	1	113
Clark
HSV 1 and
HSV 2	eq**	1	0	1	2
	-***	3	4	54	61
	Total	116	4	56	176

Wampole Herpes Group IgG ELISA

Relative Sensitivity = 112/113 = 99.1%	95% Confidence interval = 97.4% - 100%
Relative Specificity = 54/57 = 94.7%	95% Confidence interval = 88.8% - 100%
Relative Agreement = 166/170 = 97.7%	95% Confidence interval = 95.3% - 100%

Equivocals were not included in the above calculations. The 95% confidence intervals were calculated using the normal method.

Indicates positive on Clark HSV 1 and/or Clark HSV 2.

** Indicates equivocal on Clark HSV 1 and/or Clark HSV 2.

The forth site was a clinical laboratory located in Wisconsin. The frozen sera were random normal samples. The results of the studies are compiled and summarized in Table 4.

Table 4 Comparison of Herpes Group IgG ELISA and Clark Herpes 1 & 2 Study 4

Wampole Herpes Group IgG ELISA + eg

		+	eq	-	Total
Clark
Herpes 1 & 2	+*	62	0	0	62
	eq**	0	0	0	0
	-***	1	0	25	26
	Total	63	0	25	88

Relative Sensitivity = 62/62 = 100.0%	95% Confidence interval = 95.3% - 100%
Relative Specificity = 25/26 = 96.2%	95% Confidence interval = 96.2% - 100%
Relative Agreement = 87/88 = 98.9%	95% Confidence interval = 98.9% - 100%

Equivocals were not included in the above calculations.

The 95% confidence intervals were calculated using the normal method. The 95% confidence interval for sensitivity was calculated assuming one false negative.

Indicates positive on Clark HSV 1 and/or Clark HSV 2.

** Indicates equivocal on Clark HSV 1 and/or Clark HSV 2.

The results of the four studies are compiled and summarized in Table 5.

Table 5 Comparison of Herpes Group IgG ELISA and Clark HSV 1 and HSV 2

		+	eq	-	Total
Clark
HSV 1 &
HSV 2	+*	370	7	4	381
	eq**	5	0	1	6
	-***	7	6	203	216
	Total	382	13	208	603

Wampole Herpes Group IgG ELISA

Relative Sensitivity = 370/374 = 98.9%	95% Confidence interval = 97.9% - 100%
Relative Specificity = 203/210 = 96.7%	95% Confidence interval = 94.2% - 99.1%
Relative Agreement = 573/584 = 98.1%	95% Confidence interval = 97.0% - 99.2%

Equivocals were not included in the above calculations. The 95% confidence intervals were calculated using the normal method.

Indicates positive on Clark HSV 1 and/or Clark HSV 2.

** Indicates equivocal on Clark HSV 1 and/or Clark HSV 2.

*** Indicates negative on both Clark HSV 1 and Clark HSV 2.

Precision. Seven sera were assayed ten times each on three different assays at three different sites. The intersite precision is shown in Table 6. With appropriate technique the user should obtain precision of