Intended Use: For In Vitro Diagnostic Use Only. The SeraQuest HSV Type 2 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 2 herpes simplex virus (HSV) in human serum. The test is indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The predictive value of a positive or negative result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection.

The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for immunocompromised patients, pediatric patients or matrices other than human serum.

Device Description

The SeraQuest® HSV Type 2 Specific IgG test is a solid-phase enzyme-linked immunoassay (ELISA) , which is performed in microwells, at room temperature, and in three thirty minute incubations The test detects IgG antibodies which are directed against HSV 2 type-specific antigens in human serum. The Calibrator in the SeraQuest® HSV Type 2 Specific IgG test set has been assigned Index values based on an in-house standard. Test results are reported as Index values.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the SeraQuest HSV Type 2 Specific IgG device, based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criterion	Reported Device Performance (SeraQuest HSV Type 2 Specific IgG)
Precision	Intra-assay CV% for positive control: 9.9%
	Inter-assay CV% for positive control: 13.7%
	Inter-laboratory CV% for positive control: 15.4%
	Total CV% for positive control: 13.0%
	(Similar data provided for negative control and 6 samples)
Specificity (Cross-reactivity)	No false positives for HSV 1 IgG, CMV IgG, VZV EBNA/VCA/IgG, Measles IgG, Rubella IgG, Toxoplasma IgG, Syphilis IgG, Human Papilloma Virus, Neisseria gonorrhea.
	One false positive out of 8 for Chlamydia trachomitis.
Interference	No significant interference observed with elevated levels of hemoglobin, glucose, cholesterol, globulin, unconjugated bilirubin, conjugated bilirubin, human albumin, and ascorbic acid.
Relative Sensitivity & Specificity (Sexually Active Adults vs. Immunoblot)	Sensitivity: 91.8% (95% CI: 82.2 to 96.5)
	Specificity: 94.2% (95% CI: 87.9 to 97.3)
Relative Sensitivity & Specificity (Expectant Mothers vs. Immunoblot)	Sensitivity: 98.9% (95% CI: 93.8 to 99.8)
	Specificity: 99.4% (95% CI: 96.4 to 99.9)
Agreement with CDC Panel	Total Agreement: 100% (30/30 positive, 70/70 negative)

Study Details

Sample Size used for the test set and data provenance:
- Precision Testing: 6 serum specimens (2 negative, 4 positive) and the SeraQuest Positive and Negative Controls. Each sample/control was assayed in triplicate, on three separate occasions, at three different laboratories (Quest International and two external independent laboratories). This results in a total of 27 data points per sample/control (3 triplicates * 3 occasions * 3 labs).
- Specificity Testing:
  - HSV 1 IgG: 9 samples
  - CMV IgG: 11 samples
  - VZV EBNA IgG: 14 samples
  - VZV VCA IgG: 17 samples
  - VZV IgG: 21 samples
  - Measles IgG: 19 samples
  - Rubella IgG: 18 samples
  - Toxoplasma IgG: 6 samples
  - Syphilis IgG: 4 samples
  - Human Papilloma Virus: 7 samples
  - Chlamydia trachomitis: 8 samples
  - Neisseria gonorrhea: 7 samples
  - Provenance: Samples positive for various related pathogens/antibodies but negative for Type 2 HSV by another legally marketed device. Human Papilloma Virus, Chlamydia trachomitis, and Neisseria gonorrhea samples were from individual patients with confirmed sexually transmitted infections.
- Interference Testing: Samples that were negative, weakly positive, and moderately positive for antibodies to Type 2 HSV were tested with and without the addition of elevated levels of specific interfering substances. (No specific number of samples provided for this test).
- Comparison with Predicate Device:
  - Sexually Active Adults: 164 serum samples. Provenance: Prospectively collected, masked, archived, and tested at Quest International, Inc. from a clinical laboratory in the Southeastern United States.
  - Expectant Mothers: 242 serum samples. Provenance: Prospectively collected, masked, archived, and tested at Quest International, Inc. from clinical laboratories in the Northeastern and Southeastern United States. 82% from first trimester, 8% second, 10% third.
- CDC Panel: 100 sera (30 HSV-2 IgG positive and 70 HSV-2 IgG negative samples). Provenance: Centers for Disease Control and Prevention (CDC) serum panel.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated for most studies.
- For the cross-reactivity study, the samples were determined positive for various related pathogens "by other legally marketed devices" and confirmed negative for Type 2 HSV by a legally marketed device. This implies a standard diagnostic process, but no specific human experts or qualifications are mentioned for this initial determination.
- For the comparative studies with the predicate device (Immunoblot), the ground truth was established by the predicate device itself. While the predicate device is a "legally marketed" test, it doesn't specify human expert interpretation or qualifications.
- For the CDC Panel, the ground truth is "CDC consensus results" and the panel samples are described as "well characterized," implying established expert consensus or reference methods. No specific number of experts or their qualifications are detailed.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not explicitly stated. The ground truth seems to be established by reference methods or legally marketed devices rather than direct human adjudication of results in most cases. For the CDC panel, it's "CDC consensus results," which implies an agreed-upon truth, but the adjudication method isn't described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study involving human readers or AI assistance was conducted or reported for this device. This is an IVD (In Vitro Diagnostic) assay, not an imaging AI device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance characteristics (sensitivity, specificity, precision, etc.) of the SeraQuest HSV Type 2 Specific IgG assay were evaluated as a standalone device. Its results are compared to a predicate device (Immunoblot) or a "well characterized serum panel" (CDC panel). There is no "human-in-the-loop" component described for this specific device in the context of its performance evaluation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Precision: Internal controls and reference samples.
- Specificity: Samples characterized by other legally marketed devices (positive for related pathogens, negative for HSV-2) and confirmed sexually transmitted infections.
- Interference: Artificially spiked samples.
- Comparison Studies: A "commercial HSV 2 Immunoblot test" (predicate device) was used as the reference standard for both sexually active adults and expectant mothers. This is a type of reference test ground truth.
- CDC Panel: "CDC consensus results" from a "well characterized serum panel." This implies expert consensus or a gold standard determination for each sample in the panel.
The sample size for the training set: Not applicable and not mentioned. This document describes the performance evaluation of a medical device (an ELISA assay), not a machine learning or AI model that requires a "training set."
How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 13, 2016

Quest International, Inc. Dr. David J. Kiefer, Ph.D. Director, Research and Development 8127 NW 29th Street Miami, FL 33122

Re: K152353

Trade/Device Name: SeraQuest HSV Type 2 Specific IgG Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological assays Regulatory Class: Class II Product Code: MYF Dated: April 14, 2016 Received: April 14, 2016

Dear Dr. Kiefer:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Stephen J. Lovell -S for

Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152353

Device Name SeraOuest HSV Type 2 Specific IgG

Indications for Use (Describe)

Intended Use: For In Vitro Diagnostic Use Only. The SeraQuest HSV Type 2 Specific IgG assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative detection of human IgG antibodies to type 2 herpes simplex virus (HSV) in human serum. The test is indicated for sexually active individuals and expectant mothers as an aid in the presumptive diagnosis of HSV-2 infection. The predictive value of a positive or negative result depends on the prevalence of HSV-2 infection in the population and the pre-test likelihood of HSV-2 infection.

For In Vitro Diagnostic Use Only.
A positive result indicates previous exposure to Type 2 Herpes Simplex Virus.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510k Summary

510(k) Summary

Applicant:	Quest International, Inc.8127 NW 29th StreetDoral, FL. 33122
Registration No.	1061839
Contact Person:	David J. Kiefer, Ph.D.
Telephone:	305 592-6991
Telefax:	305 592-6834
Device:	SeraQuest® HSV Type 2 Specific IgG
Medical Device Group:	In vitro diagnostic
Device Classification:	Class 2

Catalogue Number: 01-420

Description:

Index	Result	Interpretation
$\leq$ 0.9	Negative	No HSV-2 IgG antibodies detected. Patient is presumed not tohave had a previous HSV-2 infection.
0.9 < X < 1.0	Equivocal	Obtain an additional sample for re-testing
$\geq$ 1.0	Positive	IgG antibody to HSV-2 detected.

Notes:

1. A single positive result only indicates previous immunologic exposure; the level of antibody response may not be used to determine active infection or disease stage.
1. When equivocal results are obtained, another specimen should be obtained ten to fourteen days later, and tested in parallel with the initial specimen. If the second specimen is also

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equivocal, the patient is negative for primary or recent infection, and equivocal for antibody status. If the second sample is positive, the patient can be considered to have previous experience with HSV-2 infection.

1. Values obtained with different manufacturer's assay methods may not be used interchangeably. The magnitude of the reported IgG index value cannot be correlated to an endpoint titer. The magnitude of results above the cut-off is not an indicator of total antibody present.

Principle:

Diluted patient samples are incubated in antigen-coated wells. HSV Type 2 antibodies, if present in the patient sample, are immobilized in the wells by binding to the antigen. Residual sample is eliminated by washing and draining, and conjugate (enzyme-labeled antibodies to human IgG) is added and incubated. If IgG antibodies to HSV-2 are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and the substrate is added and incubated. In the presence of the substrate is converted to a yellow end-product which is read photometrically.

Intended Use:

Predicate Device:

A commercial, legally marketed HSV 1 and 2 Immunoblot IgG test.

Characteristic	SeraQuest HSV 2 IgG	HSV 1 and 2 Immunoblot IgG

Technology	Enzyme Immunoassay	Immunoblot
Intended Use	Intended Use: For In VitroDiagnostic Use Only. TheSeraQuest HSV Type 2Specific IgG assay is an	For In Vitro Diagnostic Use.For qualitatively detecting thepresence or absence ofhuman IgG class antibodies to

	enzyme-linkedimmunosorbent assay(ELISA) intended for thequalitative detection of humanlgG antibodies to type 2herpes simplex virus (HSV) inhuman serum. The test isindicated for sexually activeindividuals and expectantmothers as an aid in thepresumptive diagnosis ofHSV-2 infection. Thepredictive value of a positiveor negative result depends onthe prevalence of HSV-2infection in the population andthe pre-test likelihood of HSV-2 infection.The test is not FDA clearedfor screening blood or plasmadonors. The performance ofthis assay has not beenestablished forimmunocompromisedpatients, pediatric patients ormatrices other than humanserum.	HSV-1 and HSV-2 in humansera. The test is indicated fortesting sexually active adultsor expectant mothers foraiding in the presumptivediagnosis of HSV-1 and HSV-2 infection. The predictivevalue of a positive or negativeresult depends on thepopulation's prevalence andthe pre-test likelihood of HSV-1 or HSV-2 infection. Theperformance of this assay hasnot been established for usein a pediatric population, forneonatal screening, for testingimmuno-compromisedpatients, for use by a point ofcare facility, or for use withautomated equipment.
Solid Phase	Polystyrene Microwells	Nitrocellulose membrane
Antigen	Purified HSV gG 2	Recombinant HSV gG1 andHSV gG2
Incubation Periods	Three	Three
Sample Dilution	1:51	1:101
Sample Volume	100 µL	2000 µL
Sample Incubation Duration	30 minutes	60 minutes
Incubation Temperature	Room Temperature	Room Temperature
Washing Steps	Two	Four
Cycles per Washing Step	Four	Three
Enzyme-Labeled Conjugate	Alkaline PhosphataseConjugated Goat Anti-HumanlgG	Alkaline PhosphataseConjugated Goat Anti-HumanlgG

Conjugate Volume	100 μL	2000 μL
Conjugate Incubation	30 minutes	30 minutes
Enzyme Substrate	p-nitrophenyl phosphate	Bromo-chloro-indolylphosphate and nitro bluetetrazolium
Substrate Volume	100 μL	2000 μL
Substrate Incubation	30 minutes	5 to 30 minutes
Stop Reagent	0.5 M Trisodium Phosphate	DI Water
Stop Reagent Volume	100 μL	5 X 2000 μL
Drying Step	None	Air dry, 10 minutes
Readout	Spectrophotometric405 nm	Visual

Table 1. Device Comparison

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Summary of Performance Testing

1. Precision Testing

Six serum specimens (2 negative) and 4 positive) and the SeraQuest HSV Type 2 Specific IgG Positive and Negative Controls, were assayed in triplicate, on three separate occasions, at Quest International and at two external independent laboratories. The results are summarized below in Table 2.

Table 2.

Results of Intra-assay, Inter-assay and Inter-laboratory Precision Tests Performed at Quest International and at Two External, Independent Laboratories. The Means, Standard Deviations and Coefficients of Variation were Calculated from the SeraQuest Index values.

Name of AnalytePanel Member	SampleN	MeanIndex	Intra-assay		Inter-assay		Inter-laboratory		Total
			SD	CV%	SD	CV%	SD	CV%	SD	CV%
SeraQuest PositiveSerum Control	27	2.0	0.20	9.9	0.27	13.7	0.31	15.4	0.26	13.0
SeraQuest NegativeSerum Control	27	0.3	0.04	13.5	0.08	21.2	0.15	48.2	0.09	27.6
Negative Sample # 1	27	0.3	0.08	26.7	0.10	31.2	0.11	35.9	0.10	31.3
Negative Sample # 2	27	0.4	0.04	9.6	0.06	14.4	0.09	21.6	0.06	15.2
Positive Sample # 1	27	1.8	0.15	8.3	0.19	10.7	0.23	12.4	0.19	10.5
Positive Sample # 2	27	2.1	0.12	5.7	0.18	8.8	0.21	10.0	0.17	8.1
Positive Sample # 3	27	2.8	0.16	5.6	0.25	9.0	0.32	11.4	0.24	8.7
Positive Sample # 4	27	3.5	0.27	7.8	0.38	10.7	0.42	11.9	0.36	10.1

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2. Specificity Testing

A cross-reactivity study was performed to determine if samples from various disease states and other potentially cross-reacting agents interfere with the test results. The samples were determined to be positive for IgG antibodies directed against taxonomically related viruses and other related pathogens by other legally marketed devices. Human Papilloma Virus, Chlamydia trachomitis, and Neisseria gonorrhea samples were from individual patients with confirmed sexually transmitted infections. The samples were also tested for Type 2 HSV antibody by another legally marketed device. Only those samples that tested negative for Type 2 HSV antibody by the legally marketed device were included in the study. The results of this study are shown below in Table 3.

Table 3. Results of SeraQuest HSV Type 2 Specific IgG Tests of Samples Which Tested Positive for Antibodies Directed Against Taxonomically Related Viruses and Other Viruses and Pathogens but Negative for Type 2 HSV by Other Legally Marketed Devices.

Samples	Number of Samples	Number of Samples Testing Positive in theSeraQuest HSV 2 Type Specific IgG Test
HSV 1 IgG	9	0/9
CMV IgG	11	0/11
VZV EBNA IgG	14	0/14
VZV VCA IgG	17	0/17
VZV IgG	21	0/21
Measles IgG	19	0/19
Rubella IgG	18	0/18
Toxoplasma IgG	6	0/6
Syphilis IgG	4	0/4
Human Papilloma Virus	7	0/7
Chlamydia trachomitis	8	1/8
Neisseria gonorrhea	7	0/7

3. Interference Testing

The effects of icterus, hemolysis, hyperdicidemia and hyperproteinemia on the test results were examined. Samples that were negative, weakly positive and moderately positive for antibodies to Type 2 HSV were tested with and without the addition of elevated levels of the following potential interfering substances: hemoglobin 18 g/dL, glucose 800 mg dL. cholesterol 2,720 mg/dL, globulin 28 g/dL, unconjugated bilirubin 20 mg/dL, conjugated bilirubin 20 mg/dL, human albumin 12 g/dL and ascorbic acid 3mg/dL.

No significant interference was observed in the presence of abnormally elevated levels of the potentially interfering substances tested, however the use of grossly hemolyzed, icteric or lipemic samples, as well as samples containing particulate matter or exhibiting obvious microbial contamination is not recommended and they should not be tested.

4. Comparison With The Predicate Device

One hundred and sixty-four serum samples, from sexually active adults that were submitted for HSV serology to a clinical laboratory in the Southeastern United States, were prospectively collected, masked, archived, and tested at Quest International, Inc. using the SeraQuest HSV

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Type 2 Specific IgG test and a commercial HSV 2 Immunoblot test. The results of this comparative test are shown in Table 4 below.

Table 4

Relative Sensitivity and Specificity of the SeraQuest HSV 2 Type Specific IgG Test, in Comparison with an HSV 2 Immunoblot Test, in Parallel Tests of 164 Sexually Active Adults Whose Sera Had Been Submitted for Herpes Simplex Virus Serology.

SeraQuest HSV 2 Type Specific IgG Result
	Positive	Equivocal	Negative		% Agreement*	95% C.I.*
HSV 2 ImmunoblotResult
Positive	56	0	5	Sensitivity	91.8	82.2 to 96.5
Negative	6	0	97	Specificity	94.2	87.9 to 97.3

Two hundred and forty-two serum samples, from expectant mothers, that were submitted for HSV serology to clinical laboratories in the Northeastern and Southeastern United States, were prospectively collected, masked, archived, and tested at Quest International, Inc. using the SeraQuest HSV Type 2 Specific IgG test and a legally marketed, HSV 2 Immunoblot test. One hundred and ninety-eight (82%) of the specimens were obtained during the first trimester, nineteen (8%) during the second trimester and twenty-five (10%) during the third trimester of pregnancy. The results of this comparative test are shown in Table 5 below.

Table 5

Sensitivity and Specificity of the SeraQuest HSV 2 Type Specific IgG Test, in Comparison with a Commercial HSV 2 Immunoblot Test, in Parallel Tests of 242 Expectant Mothers Whose Sera Had Been Submitted for Herpes Simplex Virus Serology.

Seraquest HSV 2 Type Specific IgG Result
HSV 2 Immunoblot Result	Positive	Equivocal	Negative	% Agreement*	95% C.I.*
Positive	87	0	1	Sensitivity 98.9	93.8 to 99.8
Negative	0	1	153	Specificity 99.4	96.4 to 99.9

CDC Panel Results

The following information was obtained with the Centers for Disease Control and Prevention (CDC) serum panel for HSV serology assays, which was tested in-house by the SeraQuest HSV Type 2 Specific IgG test. The results are presented as a means to convey further information on

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the performance of this assay with a masked, well characterized serum panel. This does not imply an endorsement by the CDC.

Percent Agreement with the CDC Panel

The panel consists of 30 HSV-2 IgG positive and 70 HSV-2 IgG negative samples. The SeraQuest HSV Type 2 Specific IgG test demonstrated 100% total agreement with the CDC consensus results. The results of this study are shown below in Table 7.

Table 7 SeraQuest HSV Type 2 Specific IgG Results Obtained with the CDC HSV Panel of 100 Sera

		SeraQuest HSV Type 2 Specific IgG
		Positive	Equivocal	Negative	Total
CDC HSV 2 Result	Positive	30	0	0	30
	Negative	0	0	70	70
	Total	30	0	70	100

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).