The Gold Standard Diagnostics Herpes Simplex Virus Type 1 IgG ELISA Test Kit is intended for the qualitative detection of IgG antibodies to Herpes Simplex Virus Type 1 (HSV-1) in human serum. The test is indicated for sexually active individuals and expectant mothers as an aid for the presumptive diagnosis of HSV-1 infection.

The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-1. The test is not intended for screening of blood and plasma donors. The performance of this assay has not been established for use in a pediatric population, neonates, or immunocompromised patients.

Device Description

The Gold Standard Diagnostics Herpes Simplex Virus (HSV) Type I IgG ELISA Test is an enzyme linked immunosorbent assay for the qualitative detection of IgG antibodies to HSV-1 in human serum. The assay requires a total of 90 minutes incubation time. The test uses microtiter wells coated with a recombinant gG1 protein of HSV-1. Serum is added to each well and incubated for 30 minutes at 37℃. If antibodies are present they will bind to the antigen in the well. Unbound antibodies are removed by washing the wells three times. A Horse Radish Peroxidase (HRP) conjugated goat anti-human IgG (conjugate) is then added to each well and incubated for 30 minutes at 37°C. If antibodies are present in the patient's serum, the conjugate will bind to the antibody attached to the antigen on the wells are again washed to remove any unbound conjugate. In order to detect the bound conjugate a substrate containing tetramethylbenzidine (TMB) is added to each well and incubated for 30 minutes at 37°C. If conjugate is present, the HRP will react with the substrate to generate a colored product. After the incubation period, the reaction is stopped with a . Stop Solution and the color intensity is measured spectrophotometrically. The kit also includes a Wash Buffer, Diluent, a Negative Control, and a Cutoff Control. The cut-off control is used to determine the validity of the assay and subsequently to determine the result of the sample. Positive and Negative controls are provided to determine if the assay is functioning properly. The kit contains 12 x 8well antigen coated microtiter strips in a frame. The reagents are sufficient for 96 determinations.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly defined by its comparison to a legally marketed predicate device (Focus Diagnostics HerpeSelect® 1 and 2 Immunoblot IgG) and by demonstrating acceptable precision, reproducibility, cross-reactivity, and interference performance. The document doesn't explicitly state numerical acceptance criteria for sensitivity and specificity a priori but lists the achieved performance values.

Test Category	Acceptance Criteria (Implicit)	Reported Device Performance
Clinical Performance	Substantial equivalence to predicate device in intended use populations (pregnant women, sexually active adults, low prevalence). Comparable sensitivity and specificity to predicate.	Pregnant Women:Sensitivity = 96.0% (95% C.I. = 90.1% - 98.9%)Specificity = 96.5% (95% C.I. = 90.0% - 99.3%)Sexually Active Adults:Sensitivity = 92.3% (95% C.I. = 88.6% - 95.0%)Specificity = 95.5% (95% C.I. = 91.8% - 97.8%)Low Prevalence:Sensitivity = 93.8% (95% C.I. = 69.7% - 99.8%)Specificity = 92.9% (95% C.I. = 85.1% - 97.3%)CDC Seroconversion Panel:Sensitivity = 97.8% (95% C.I. = 88.5% - 99.9%)Specificity = 94.4% (95% C.I. = 84.6% - 98.8%)
Precision (Within-lab)	Demonstrable precision across various sample types (high positive, moderate positive, low positive, near cutoff, high negative, negative). CV values indicating low variability.	High Positive: SD 1.544, CV 2.6% (within-run); Total CV 13.1%Moderate Positive: SD 1.290, CV 5.2% (within-run); Total CV 14.6%Low Positive: SD 0.664, CV 3.7% (within-run); Total CV 15.0%Near Cutoff: SD 0.601, CV 4.4% (within-run); Total CV 13.7%High Negative: SD 0.388, CV 5.9% (within-run); Total CV 14.5%Negative: SD 0.153, CV 8.0% (within-run); Total CV 18.0%
Reproducibility	Reproducibility across multiple sites, days, runs, and technicians for various sample types. CV values indicating acceptable variability.	Overall (across 3 sites):High Positive: Overall Total CV 9.5%Low Positive: Overall Total CV 14.6%Positive Cutoff: Overall Total CV 5.2%Negative Cutoff: Overall Total CV 2.9%High Negative: Overall Total CV 10.9%Negative: Overall Total CV 14.6% (Site-specific data also provided with similar CVs)
Cross-Reactivity	Minimal or no cross-reactivity with common infectious diseases and conditions. If reactive, it should align with predicate device.	10 tested for each with: CMV (0 reactive), EBV (1* reactive), VZV (1* reactive), Chlamydia trachomatis (0 reactive), Treponema pallidum (0 reactive), HPV (0 reactive), Rubella Virus (0 reactive), Toxoplasma gondii (3* reactive), Candida albicans (2* reactive), Neisseria gonorrhea (0 reactive), Rheumatoid Factor (0 reactive), ANA (0 reactive), Measles (0 reactive), HSV-2 (0 reactive), HIV (4* reactive), Bacteroides (0 reactive). *Samples also reactive with predicate device.
Interfering Substances	Performance unaffected (within ±20%) by specified high concentrations of common interfering substances (hemoglobin, bilirubin, cholesterol, triglycerides, albumin).	Performance not affected by: Hemoglobin (2 g/L), Bilirubin (342 µmol/L), Cholesterol (13 mmol/L), Triglycerides (37 mmol/L), Albumin (60 g/L). (Acceptance criterion of ±20% was used.)

2. Sample Size Used for the Test Set and Data Provenance

Clinical Performance Test Set:
- Total Samples: 703 samples.
- Pregnant Women: 185 samples.
- Sexually Active Adults: 518 samples.
- Low Prevalence Population: 96 samples (sera ages 16-19 years old).
- CDC Seroconversion Panel: 100 samples (46 positive, 54 negative - implied from counts).
Data Provenance:
- Pregnant Women and Sexually Active Adults: Prospectively collected.
- Low Prevalence Population: Prospectively collected in a non-STD setting. Tested in-house.
- CDC Seroconversion Panel: Obtained from the CDC. Tested in-house.
- Cross-reactivity samples: Obtained from serum brokers.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth for the clinical performance study (the primary test set) was established by comparison to a commercially available predicate device: Focus Diagnostics HerpeSelect® 1 and 2 Immunoblot IgG test (K000238). The document does not mention the use of human experts to establish ground truth for this comparison study, as the predicate device itself serves as the reference.

For the cross-reactivity study, ground truth for the "positive for" status of the samples was confirmed by "serum brokers who confirmed positivity for each respective disease and conditions using FDA cleared tests." The number and specific qualifications of these "serum brokers" or the experts validating the FDA cleared tests are not specified.

4. Adjudication Method for the Test Set

For the clinical performance studies comparing the Gold Standard Diagnostics ELISA to the Focus Diagnostics Line Blot, the adjudication method for discordant results (equivocal results) was explicitly stated: "Equivocal results were treated as the worst case results (disagreement)". This implies that equivocal results were counted as disagreements with the predicate device's result when calculating sensitivity and specificity.

5. 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, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) ELISA test, which does not involve human readers interpreting images or data to the extent that an MRMC study for AI would typically describe. The "reading" is done by a spectrophotometer, and the comparison is between two IVD assay technologies.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the device's performance as an algorithm-only system (an ELISA test measured by a spectrophotometer) was evaluated. The results presented for sensitivity, specificity, precision, reproducibility, cross-reactivity, and interfering substances all represent the standalone performance of the Gold Standard Diagnostics Herpes Simplex Virus Type 1 IgG ELISA Test Kit. There is no human-in-the-loop component described for the operation or interpretation of this particular assay's results.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The primary type of ground truth used was comparison to a legally marketed predicate device (Focus Diagnostics HerpeSelect® 1 and 2 Immunoblot IgG test).

Additionally:

For the cross-reactivity panel, the ground truth for specific infections was established by "FDA cleared tests" as reported by serum brokers.
For the CDC seroconversion panel, the ground truth was based on "well-characterized HSV I serum samples" obtained from the CDC, indicating a highly validated and accepted reference standard.

8. The Sample Size for the Training Set

The document does not mention a training set in the context of an algorithm or machine learning. This is an ELISA kit, which is a biochemical assay, not an AI/ML algorithm that requires training data in the traditional sense. The development and optimization of the ELISA kit would involve internal validation and batch testing, but this is distinct from an AI training set.

9. How the Ground Truth for the Training Set was Established

As explained above, there is no "training set" for this type of device in the AI/ML context. The assay's performance characteristics are established through analytical and clinical studies comparing it to known standards (predicate device, CDC panel) and characterized samples.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Gold Standard Diagnostics. The logo includes the company name in bold, black letters, with a globe symbol incorporated into the "G". The image also includes the date "FEB 2 8 2014" on the right side of the logo.

510(k) Summary

Gold Standard Diagnostics 1) Submitter's Name: 2851 Spafford St. Davis, CA. 95618 Address: Phone Number: 530-759-8000 Fax Number: 530-759-8012 Contact Person: Napoleon Monce Date: February 11, 2014

1. Product and Trade Name: Herpes Simplex Virus Type 1 IgG ELISA Test
  Common Name: Herpes Simplex Virus, HSV-1

Classification Name: Herpes simplex virus serological assays (Class 2, 21 CFR 866.3305)

Product Code: MXJ

3) Legally marketed device to which the submitter claims equivalence:

Focus Diagnostics HerpeSelect® I and 2 Immunoblot IgG for the qualitative detection of human IgG class antibody to HSV-1 and HSV-2. K000238.

4) Description of the device:

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sample. Positive and Negative controls are provided to determine if the assay is functioning properly. The kit contains 12 x 8well antigen coated microtiter strips in a frame. The reagents are sufficient for 96 determinations.

5) Intended Use / Indication for Use:

6) Comparison with the predicate device:

The Gold Standard Diagnostics Herpes Simplex Virus Type 1 IgG ELISA Test Kit was compared to a commercially manufactured by Focus Diagnostics, the HerpeSelect® 1 and 2 Immunoblot IgG test (K000238). Both kits have the same intended use. Below are tables comparing the reagents provided and the procedural steps performed by each device.

Gold Standard Diagnostics Herpes SimplexVirus Type 1 IgG ELISA Test Kit	Focus HerpeSelect® 1 and 2Immunoblot IgG
Antigen coated Microtiter Plate - 96 wells	Antigen coated nitrocellulose strips
Wash Solution - 20x	Wash Buffer and Diluent - 10x
Diluent - Ready to Use	None
IgG Conjugate – Anti Human HRP	IgG Conjugate – Anti Human Peroxidase
Substrate - Tetramethylbenzidine (TMB)	Substrate - BCIP/NBT
Stop Solution – Acid mixture	Stop Solution – DI water
Positive Control	Positive Control
Cutoff Control	No Cutoff Control provided
Negative Control	Negative Control

Table 1: Reagent Comparison

Table 2: Procedure Comparison

Gold Standard Diagnostics Herpes SimplexVirus Type 1 IgG ELISA Test Kit	Focus HerpeSelect® 1 and 2Immunoblot IgG
Intended Use: Qualitative detection of IgGantibodies to HSV-1 in human serum. Thetest is indicated for sexually active individualsand expectant mothers as an aid for the	Same

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presumptive diagnosis of HSV-1 infection.The predictive value of positive or negativeresults depends on the population'sprevalence and the pretest likelihood of HSV-1. The test is not intended for screening ofblood and plasma donors. The performanceof this assay has not been established for usein a pediatric population, neonates, orimmunocompromised patients.
Dilute Samples 1:101 in Diluent	Same
Add 100ul of Samples and Controls	Add 2ml of Samples and Controls
Incubate for 30 minutes at 37°C	Incubate for 60 minutes at RT while rocking
Wash four times with reconstituted WashSolution	Wash three times with Wash Solution with 5minute rocking incubation between washes
Add 100ul of Conjugate	Add 2ml of Conjugate
Incubate for 30 minutes at 37°C	Incubate for 60 minutes at RT while rocking
Wash four times with reconstituted WashSolution	Wash three times with Wash Solution with 5minute rocking incubation between washes
Add 100ul of Substrate	Add 2ml of Substrate
Incubate for 30 minutes at 37°C	Incubate for 5 to 30 minutes at RT whilerocking
Add 50ul of Stop Solution	Rinse with DI water to stop the reaction
Read with Spectrophotometer at 450nm	Read visually

7) Analytical performance:

Precision:

A within-lab precision study was conducted for 12 days, two runs per day, two replicates per run and three lots. Every lot was tested for four days. The mean results are summarized in the table below:

Sample	N	Units		Within-Run	Between-Run	Between-Day	Total
HighPositive	48	58.452	SD	1.544	1.261	5.644	7.652
	48		CV	2.6%	2.5%	9.7%	13.1%
ModeratePositive	48	24.955	SD	1.290	1.088	2.982	3.653
	48		CV	5.2%	5.0%	11.9%	14.6%
LowPositive	48	18.183	SD	0.664	0.601	1.856	2.732
	48		CV	3.7%	3.8%	10.2%	15.0%
Near	48	13.691	SD	0.601	0.501	1.388	1.871
	48		CV

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Cutoff			CV	4.4%	4.2%	10.1%	13.7%
HighNegative	48	6.565	SD	0.388	0.343	0.579	0.950
			CV	5.9%	6.1%	8.8%	14.5%
Negative	48	1.899	SD	0.153	0.133	0.256	0.342
			CV	8.0%	8.0%	13.5%	18.0%

Reproducibility:

The reproducibility of the assay was performed using six samples (a high positive, a sample near the positive cutoff, a sample near the negative cutoff, a high negative and a negative sample). Each sample was tested for five days, twice a day, at three sites with two technicians per site, each performing one run per day. The mean results of the overall and per site reproducibility are summarized in the tables below:

Overall
Sample	N	Mean(Units)	Within-Run	Between-Run	Between-Day	Between-Site	OverallTotal
HighPositive	60	60.909	SD	2.487	2.535	3.749	4.952	5.788
			CV	4.1%	4.2%	6.2%	8.1%	9.5%
LowPositive	60	14.754	SD	0.775	0.758	0.957	1.369	2.156
			CV	5.2%	5.1%	6.5%	9.3%	14.6%
PositiveCutoff	60	11.821	SD	0.235	0.235	0.379	0.615	0.617
			CV	2.0%	2.0%	3.2%	5.2%	5.2%
NegativeCutoff	60	9.585	SD	0.108	0.105	0.174	0.254	0.280
			CV	1.1%	1.1%	1.8%	2.7%	2.9%
HighNegative	60	7.508	SD	0.194	0.195	0.447	0.760	0.821
			CV	2.6%	2.6%	6.0%	10.1%	10.9%
Negative	60	1.579	SD	0.093	0.094	0.160	0.213	0.231
			CV	5.9%	6.0%	10.1%	13.5%	14.6%

Site 1
Sample	N	Mean		Within-Run	Between-Run	Between-Day	OverallTotal
HighPositive	20	59.224	SD	2.569	2.643	3.370	4.360
			CV	4.3%	4.5%	5.7%	7.4%
LowPositive	20	13.302	SD	0.868	0.845	0.942	1.303
			CV	6.5%	6.3%	7.1%	9.8%
PositiveCutoff	20	11.759	SD	0.133	0.138	0.291	0.585
			CV	1.1%	1.2%	2.5%	5.0%
NegativeCutoff	20	9.432	SD	0.131	0.121	0.192	0.239
			CV	1.4%	1.3%	2.0%	2.5%

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			SD
HighNegative	20	7.944	0.205	0.199	0.451	0.752
			CV
			2.6%	2.5%	5.7%	9.5%
Negative	20	1.693	SD	0.079	0.082	0.165	0.22
			CV
			4.7%	4.8%	9.8%	12.9%

Site 2
Sample	N	Mean		Within-Run	Between-Run	Between-Day	OverallTotal
HighPositive	20	58.440	SD	2.596	2.662	4.218	5.583
			CV	4.4%	4.6%	7.2%	9.6%
LowPositive	20	13.875	SD	0.787	0.767	0.990	1.462
			CV	5.7%	5.5%	7.1%	10.5%
PositiveCutoff	20	11.846	SD	0.213	0.210	0.285	0.671
			CV	1.8%	1.8%	2.4%	5.7%
NegativeCutoff	20	9.712	SD	0.102	0.104	0.193	0.249
			CV	1.1%	1.1%	2.0%	2.6%
HighNegative	20	7.282	SD	0.223	0.230	0.324	0.760
			CV	3.1%	3.2%	4.5%	10.4%
Negative	20	1.473	SD	0.10	0.10	0.15	0.20
				CV	6.6%	6.6%	10.1%

Site 3
Sample	N	Mean		Within-Run	Between-Run	Between-Day	OverallTotal
HighPositive	20	65.062	SD	2.296	2.300	3.660	4.913
			CV	3.5%	3.5%	5.6%	7.6%
LowPositive	20	17.085	SD	0.669	0.663	0.939	1.341
			CV	3.9%	3.9%	5.5%	7.8%
PositiveCutoff	20	11.857	SD	0.359	0.356	0.561	0.588
			CV	3.0%	3.0%	4.7%	5.0%
NegativeCutoff	20	9.610	SD	0.090	0.091	0.138	0.275
			CV	0.9%	0.9%	1.4%	2.9%
HighNegative	20	7.298	SD	0.153	0.155	0.565	0.770
			CV	2.1%	2.1%	7.7%	10.5%
Negative	20	1.571	SD	0.10	0.10	0.17	0.22
			CV	6.5%	6.6%	10.5%	13.9%

Cross Reactivity:

Potential cross reactivity was evaluated for infectious diseases and conditions. The samples were obtained from serum brokers who confirmed positivity for each respective disease and conditions using FDA cleared tests. Samples were tested on the Gold Standard Diagnostics Herpes Simplex Virus Type 1 IgG ELISA Test as well as on the predicate device. The results are summarized in the following table:

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Positive For	NumberTested	NumberReactive
Cytomegalovirus (CMV)	10	0
Epstein-Barr Virus (EBV)	10	1*
Varicella-zoster Virus (VZV)	10	1*
Chlamydia trachomatis	10	0
Treponema pallidum	10	0
Human papilloma virus (HPV)	10	0
Rubella Virus	10	0
Toxoplasma gondii	10	3*
Candida albicans	10	2*
Neisseria gonorrhea	10	0
Rheumatoid Factor	10	0
ANA	10	0
Measles	10	0
HSV-2	10	0
HIV	10	4*
Bacteroides	1	0

Samples were also reactive with the predicate device assay

Interfering Substances:

The effect of potential interfering substances on samples using the Gold Standard Diagnostics Herpes Simplex Virus Type 1 IgG ELISA Test was evaluated. High levels of hemoglobin, bilirubin, cholesterol. Triglycerides, and albumin in serum samples were tested at the assay cutoff in triplicate. The recommended concentrations from the guideline "Interference Testing In Clinical Chemistry" from the Clinical and Laboratory Standards Institute were used (CLSI EP7-A2). An acceptance criterion of ±20% was used. The tested substances did not affect the performance of the Gold Standard Diagnostics Herpes Simplex Virus Type 1 IgG ELISA Test if tested in the following concentration:

Substance	Concentration
Hemoglobin	2 g/L
Bilirubin	342 µmol/L
Cholesterol	13 mmol/L
Triglycerides	37 mmol/L
Albumin	60 g/L

Clinical performance:

Performance in the Intended Use Populations

The performance of the Gold Standard Diagnostics Herpes Simplex Virus Type 1 IgG ELISA assay was determined by conducting a correlation study tested at three different sites using a total of 703 samples representative of the intended use population, pregnant women and sexually active adults at risk. The samples were tested on both the Gold Standard Herpes Simplex Virus Type 1 IgG ELISA assay and a commercially available Herpes Simplex Virus Line Blot test being manufactured by

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Focus Diagnostics. Samples from pregnant women and sexually active adult were prospectively collected, submitted for HSV testing. The combined results from all three sites are summarized in the following tables, sorted according to the intended use population tested. Equivocal results were treated as the worst case results (disagreement):

Pregnant Women		Focus Diagnostics HSV-1Line Blot
		Positive	Negative
Gold StandardDiagnostics HSV-1IgG ELISA	Positive	96	1
	Equivocal	1	2
	Negative	3	82
Sensitivity = 96.0% (96/100)		(95% C.I. = 90.1% - 98.9%)
Specificity = 96.5% (82/85)		(95% C.I. = 90.0% - 99.3%)

Sexually Active Adults		Focus Diagnostics HSV-1Line Blot
		Positive	Negative
Gold StandardDiagnostics HSV-1IgG ELISA	Positive	275	8
	Equivocal	3	2
	Negative	20	210
Sensitivity = 92.3% (275/298)		(95% C.I. = 88.6% - 95.0%)
Specificity = 95.5% (210/220)		(95% C.I. = 91.8% - 97.8%)

Performance in a Low Prevalence Population

The low prevalence samples were prospectively collected in a non-STD setting from sera ages 16-19 years old. They were only tested in-house. Equivocal results were treated as the worst case/disagreement results.

Low Prevalence		Focus Diagnostics HSV-1Line Blot
		Positive	Negative
Gold StandardDiagnostics HSV-1IgG ELISA	Positive	15	3
	Equivocal	0	3
	Negative	1	78
Sensitivity = 93.8% (15/16)		(95% C.I. = 69.7% - 99.8%)
Specificity = 92.9% (78/84)		(95% C.I. = 85.1% - 97.3%)

Performance with a CDC Seroconversion Panel

A seroconversion panel consisting of well-characterized HSV I serum samples was obtained from the CDC and tested on the Gold Standard Herpes Simplex Virus Type 1 IgG ELISA test in an in-house study. The results are summarized in the table below. Equivocal results were treated as worst case/disagreement results.

A 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1	CDC
		Positive	Negative
Gold Standard	Positive	ર્વ રે
Diagnostics HSV-1	Equivocal	()	0
IgG ELISA	Negative		રી તેમને છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉત્પાદની ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉત્પાદની ખે
Sensitivity = 97.8% (45/46)Specificity = 94.4% (51/54)		(95% C.I. = 88.5% - 99.9%)(95% C.I. = 84.6% - 98.8%)

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Expected Values

To determine the prevalence of the test, a total of 703 sera consisting of pregnant women and sexually active adults were tested. The observed prevalence and the hypothetical prevalence for the two intended use populations are summarized below.

Observed Prevalence with Pregnant Women
Age (years)	Pos	Equ	Neg	Total	Prevalence
16-19	7	0	11	18	38.9%
20-24	20	0	11	31	64.5%
25-29	23	0	18	41	56.1%
30-34	26	2	28	56	46.4%
35-39	16	1	14	31	51.6%
>40	5	0	3	8	62.5%
Totals	97	3	85	185	53.5%

Observed Prevalence with Sexually Active Adults
Age (years)	Pos	Equ	Neg	Total	Prevalence
16-19	22	0	26	48	45.8%
20-24	27	1	50	78	34.6%
25-29	55	1	63	119	46.2%
30-34	58	1	30	89	65.2%
35-39	28	1	22	51	54.9%
>40	93	1	39	133	69.9%

Totals	283	5	230	518	55.0%

Hypothetical Predictive Values vs. Prevalence
	Sexually ActiveAdults		Pregnant Women
Prevalence	PPV	NPV	PPV	NPV
50%	95.4%	92.5%	96.5%	96.0%
40%	93.2%	94.9%	94.8%	97.3%
30%	89.8%	96.7%	92.2%	98.3%
25%	87.2%	97.4%	90.1%	98.6%
20%	83.7%	98.0%	87.3%	99.0%
15%	78.4%	98.6%	82.9%	99.3%
10%	69.5%	99.1%	75.3%	99.5%
5%	51.9%	99.6%	59.1%	99.8%

(Results are the worst case/disagreement results)

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8) Conclusion:

From the data, we find that the Gold Standard Diagnostics Herpes Simplex Virus Type 1 IgG ELISA assay is substantially equivalent to the commercially available Herpes Simplex Virus Line Blot test being manufactured by Focus Diagnostics (K000238).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/9/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The logo is in black and white.

Public Health Service

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

February 28, 2014

GOLD STANDARD DIAGNOSTICS NAPLEON MONCE DIRECTOR OF PRODUCT DEVELOPMENT 2851 SPAFFORD ST · DAVIS CA 95618

Re: K131334

Trade/Device Name: Herpes Simplex Virus Type 1 IgG Elisa Test Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological assays Regulatory Class: II Product Code: MXJ Dated: January 29, 2014 Received: January 30, 2014

Dear Mr. Monce:

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

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Page 2-Mr. Monce

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance 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. 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 Small Manufacturers, International and Consumer Assistance 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

Sally A. Hojvat, M.Sc., PhD. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K131334

Device Name

Herpes Simplex Virus Type 1 IgG ELISA Test

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR B01 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Stephen J. Lovell -S 2014.02.28 10:53:31 -05'00'

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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).