The BioPlex™ 2200 HSV-1 & HSV-2 IgG kit is a multiplex flow immunoassay intended for the qualitative detection and differentiation of IgG antibodies to herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) in human serum and EDTA or heparinized plasma. The test is indicated for sexually active individuals and expectant mothers as an aid for the presumptive diagnosis of HSV-1 or HSV-2 infection. The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-1 and HSV-2.

The test is not FDA cleared for screening blood or plasma donors. The performance of this assay has not been established for use in a pediatric population, neonates and immunocompromised patients or for use at point of care facilities.

The BioPlex 2200 HSV-1 & HSV-2 IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.

Device Description

The BioPlex 2200 HSV-1 & HSV-2 IgG kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional EIA, but permits simultaneous detection and identification of many antibodies in a single tube.

Two different populations of dyed beads are each coated with antigens associated with herpes simplex virus, types 1 and 2. The BioPlex 2200 System combines an aliquot of patient sample, sample diluent, and bead set reagent into a reaction vessel. The mixture is incubated at 37°C. After a wash cycle, anti-human IgG antibody, conjugated to phycoerythrin (PE), is added to the dyed beads and this mixture is incubated at 37°C. The excess conjugate is removed in another wash cycle, and the beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the dyed beads is determined by the fluorescence of the dyes, and the amount of antibody captured by the antigen is determined by the fluorescence of the attached PE. Raw data is calculated in relative fluorescence intensity (RFI).

Three additional dyed beads, an Internal Standard Bead (ISB), a Serum Verification Bead (SVB) and a Reagent Blank Bead (RBB) are present in each reaction mixture to verify detector response, the addition of serum to the reaction vessel and the absence of significant non-specific binding in serum. Refer to the BioPlex 2200 System Operation Manual for more information.

The instrument is calibrated using a set of 4 distinct calibrator vials, supplied separately by Bio-Rad Laboratories.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the BioPlex 2200 HSV-1 and HSV-2 IgG kit, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a pass/fail threshold, but rather presents performance metrics. Thus, I've interpreted the "acceptance criteria" as the performance levels demonstrated by the predicate device (implicitly accepted by the FDA) and the "reported device performance" as the BioPlex 2200's performance as measured against a commercially available immunoblot.

Assumed "Acceptance Criteria" (based on predicate performance and FDA clearance of similar devices): High sensitivity and specificity, typically above 90% in relevant populations, to reliably detect and differentiate HSV-1 and HSV-2 IgG antibodies. Precision and reproducibility should also be high (low CV).

Performance Metric	Acceptance Criteria (Implicit/Predicate Expected)	BioPlex 2200 Reported Performance
HSV-1 IgG - Sexually Active Individuals
% Sensitivity	High (e.g., >90%)	97.6% (94.5 - 99.0% CI)
% Specificity	High (e.g., >90%)	90.1% (81.7 - 94.9% CI)
HSV-2 IgG - Sexually Active Individuals
% Sensitivity	High (e.g., >90%)	90.6% (83.9 - 94.7% CI)
% Specificity	High (e.g., >90%)	98.2% (94.9 - 99.4% CI)
HSV-1 IgG - Expectant Mothers
% Sensitivity	High (e.g., >90%)	96.3% (93.5 - 97.9% CI)
% Specificity	High (e.g., >90%)	99.0% (94.6 - 99.8% CI)
HSV-2 IgG - Expectant Mothers
% Sensitivity	High (e.g., >90%)	96.9% (93.0 - 98.7% CI)
% Specificity	High (e.g., >90%)	100% (98.4 - 100% CI)
HSV-1 IgG - CDC Panel
% Positive Agreement	High (e.g., >90%)	100% (92.8 - 100% CI)
% Negative Agreement	High (e.g., >90%)	96.0% (86.5 - 98.9% CI)
HSV-2 IgG - CDC Panel
% Positive Agreement	High (e.g., >90%)	100% (92.8 - 100% CI)
% Negative Agreement	High (e.g., >90%)	100% (92.8 - 100% CI)
Reproducibility (Total %CV)	Low (e.g., <15%)	Typically <15% for all panel members across both HSV-1 and HSV-2 assays. E.g., HSV-1 High Positive: 6.9-12.2%, Low Positive: 11.3-13.9%, Near Cutoff: 13.5-15.3%, High Negative: 8.3-10.3%; HSV-2 High Positive: 8.2-8.6%, Low Positive: 10.1-10.7%, Near Cutoff: 8.9-9.4%, High Negative: 9.3-10.7%.
Precision (Total %CV)	Low (e.g., <10%)	Typically <8% for all panel members across both HSV-1 and HSV-2 assays. E.g., HSV-1 High Positive: 5.5-6.6%, Low Positive: 4.7-7.6%, Near Cutoff: 5.2%; HSV-2 High Positive: 4.8%, Low Positive: 6.1-6.3%, Near Cutoff: 4.9-6.5%.

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

Sexually Active Individuals with HSV-1 test ordered: N = 289
Sexually Active Individuals with HSV-2 test ordered: N = 286
Expectant Mothers: N = 399
CDC Panel: N = 100
Low Prevalence Population (16-19 years, non-STD setting): N = 200

Data Provenance:

Country of Origin: The comparative studies were "conducted at a total of 3 U.S. clinical sites." The low-prevalence study was conducted at "2 U.S. clinical testing sites." The CDC panel is from the U.S. Centers for Disease Control.
Retrospective or Prospective: The comparative study in intended use populations (sexually active individuals and expectant mothers) was described as a "prospective study." The low-prevalence study used "remnant serum samples," which suggests a retrospective collection, but the study itself was presumably designed prospectively for analysis. The CDC panel samples are well-characterized.

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

The document does not explicitly state the number of experts or their qualifications. The ground truth for comparative testing was established by a "commercially available immunoblot test" and a "masked, well characterized HSV serum panel from the CDC." This implies that the ground truth was based on the consensus or established characterization of these reference methods, rather than real-time expert adjudication of individual cases.

4. Adjudication Method for the Test Set

The document describes how equivocal results were handled for the comparative effectiveness study:

"For purposes of sensitivity calculations, the BioPlex 2200 equivocal results were assigned to the opposite clinical interpretation than that of the corresponding immunoblot result."
"Likewise, immunoblot equivocal results were assigned to the opposite clinical interpretation than that of the BioPlex 2200 result."

This method effectively forces equivocal results into either positive or negative, but it's important to note that this is a specific approach for calculating sensitivity and specificity and not a general adjudication method for reporting results. It doesn't describe an expert panel adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an in-vitro diagnostic (IVD) assay that directly measures antibodies; it does not involve human readers interpreting images, and therefore, does not involve AI assistance for human readers.

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

Yes, the studies presented are standalone (algorithm only) performance analyses. The BioPlex 2200 HSV-1 and HSV-2 IgG kit is an automated system that processes samples and provides quantitative (Relative Fluorescence Intensity, RFI) or qualitative (Positive, Equivocal, Negative) results without direct human interpretive input beyond running the instrument and reviewing the automated output. Its performance is compared directly against the immunological ground truth.

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

The ground truth used for the comparative studies was:

A commercially available immunoblot test (e.g., Focus HerpesSelect 1 and 2 Immunoblot IgG).
A masked, well-characterized HSV serum panel from the CDC. These panels are typically established through extensive testing using multiple reference methods and expert consensus on their true status.

8. The Sample Size for the Training Set

The document describes studies for performance validation of the device. It does not provide information on a "training set" for the development of the BioPlex 2200 assay itself. IVD devices like this are typically developed internally by the manufacturer using their own validation processes, and the 510(k) submission focuses on clinical validation results rather than details of internal algorithm training. Therefore, the sample size for a training set (if applicable to the assay's internal development) is not disclosed in this summary.

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

Since information on a specific "training set" and its size is not provided (as it's beyond the scope of a 510(k) performance summary for an IVD), details on how its ground truth was established are also not available in this document.

Summary

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BIOPLEX 2200 HSV-1 AND HSV-2 IgG 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 . . . . . . . . . . . .

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MANUFACTURER INFORMATION

Manufacturer
Manufacturer Address	Bio-Rad Laboratories, Inc.Clinical Systems Division4000 Alfred Nobel DriveHercules, CA 94547
Telephone	(510) 724-7000
Establishment Registration No.	2915274
Owner / Operator	Bio-Rad Laboratories, Inc.4000 Alfred Nobel DriveHercules, CA 94547
Owner / Operator No.	9929003
Official Correspondent for the BioPlex 2200 HSV-1 and HSV-2 IgG
Official Correspondent Address	Bio-Rad Laboratories6565 185th Ave NERedmond, WA 98052
Telephone	425-881-8300
Establishment Registration No.	3022521
Owner / Operator	Bio-Rad Laboratories6565 185th Ave NERedmond, WA 98052
Official Correspondent	Mr. Christopher Bentsen
Telephone	(425) 498-1709
Fax	(425) 498-1651

CLASSIFICATION INFORMATION

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Classification Name	Enzyme Linked Immunosorbent Assay, Herpes SimplexVirus, HSV-1
Common Name	Multi-Analyte Detection System HSV-1 and HSV-2 IgG
Product Trade Name	BioPlex 2200 HSV-1 and HSV-2 IgG on the BioPlex 2200Multi-Analyte Detection System
Device Class	Class II
Classification Panel	Microbiology
Regulation Number	866.3305
Product Code	MXJ

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BioPlex 2200 HSV-1 and HSV-2 IgG 510(k) Summary (5-1-09)

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Classification Name	Enzyme Linked Immunosorbent Assay, Herpes SimplexVirus, HSV-2
Common Name:	Multi-Analyte Detection System HSV-1 and HSV-2 IgG
Product Trade Name	BioPlex 2200 HSV-1 and HSV-2 IgG on the BioPlex 2200Multi-Analyte Detection System
Device Class	Class II
Classification Panel	Microbiology
Regulation Number	866.3305
Product Code	MYF

LEGALLY MARKETED EQUIVALENT (SE) DEVICES

Comparative FDA ClearedPREDICATE DEVICE	510(k) Number	DecisionDate
Focus HerpesSelect 1 ELISA IgG	K021429	7/29/2002
Focus HerpesSelect 2 ELISA IgG	K021486	8/1/2002
Focus HerpesSelect 1 and 2 Immunoblot IgG	K000238	4/14/2000

DEVICE DESCRIPTION

1 37011-11 14:00LL

The instrument is calibrated using a set of 4 distinct calibrator vials, supplied separately by Bio-Rad Laboratories.

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BioPlex 2200 HSV-1 and HSV-2 IgG 510(k) Summary (5-1-09)

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KIT COMPONENTS

BioPlex 2200 HSV-1 & HSV-2 IgG Reagent Pack ( 665-3350). The reagent pack contains supplies sufficient for 100 tests.

Vial	Description
Bead Set	One (1) 10 mL vial, containing dyed beads coated with HSV-1 and HSV-2IgG antigens, an Internal Standard bead (ISB), a Serum Verification bead(SVB), and a Reagent Blank bead (RBB) in buffer with Glycerol and proteinstabilizers (bovine). ProClin™ 300 (0.3%), sodium benzoate (0.1%) andsodium azide (<0.1%) as preservatives.
Conjugate	One (1) 5 mL vial, containing phycoerythrin conjugated murine monoclonalanti-human IgG antibody and phycoerythrin conjugated murine monoclonalanti-human FXIII antibody, in buffer with protein stabilizers (bovine).ProClin™ 300 (0.3%), sodium benzoate (0.1%) and sodium azide (<0.1%)as preservatives.The phycoerythrin conjugated anti-human FXIII antibody is used to verify the presence of serum or plasmain the reaction vessel.
Sample Diluent	One (1) 10 mL vial, containing buffer with protein stabilizers (bovine andmurine). ProClin™ 300 (0.3%), sodium benzoate (0.1%) and sodium azide(<0.1%) as preservatives.

ADDITIONAL REQUIRED ITEMS, AVAILABLE FROM BIO-RAD

Catalog #	Description
663-3300	BioPlex 2200 HSV-1 & HSV-2 IgG Calibrator Set: Four (4) 0.5 mL vials,each containing human antibodies to HSV-1 and HSV-2 IgG derived fromhuman disease state plasma, in a human serum matrix made fromdefibrinated plasma. All calibrators contain ProClin™ 300 (0.3%), sodiumbenzoate (0.1%) and sodium azide (<0.1%) as preservatives.
663-3330	BioPlex 2200 HSV-1 & HSV-2 IgG Control Set: Two (2) 1.5 mL PositiveControl serum vials, each containing human antibodies to HSV-1 and HSV-2 IgG derived from human disease state plasma, in a human serum matrixmade from defibrinated plasma; and two (2) 1.5 mL Negative Control serumvials, in a human serum matrix made from defibrinated plasma. All controlscontain ProClin™ 300 (0.3%), sodium benzoate (0.1%) and sodium azide(<0.1%) as preservatives.
660-0817	BioPlex 2200 System Sheath Fluid: Two (2) 4 L bottles containingPhosphate Buffered Saline (PBS). ProClin® 300 (0.3%) and Sodium azide(0.1%) as preservatives.
660-0818	BioPlex 2200 System Wash Solution: One (1) 10 L bottle containingPhosphate Buffered Saline (PBS) and Tween 20. ProClin® 300 (0.3%) andSodium azide (0.1%) as preservatives.
660-0000	BioPlex 2200 Instrument and Software. ' ' '

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BioPlex 2200 HSV-1 and HSV-2 IgG 510(k) Summary (5-1-09)

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INTENDED USE / INDICATIONS FOR USE

The BioPlex 2200 HSV-1 & HSV-2 IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.

TECHNOLOGICAL CHARACTERISTICS

The following tables summarize similarities and differences between the BioPlex 2200 HSV-1 and HSV-2 IgG Kit and the predicate device used in comparative studies with the BioPlex 2200 HSV-1 and HSV-2 IgG Kit.

BioPlex 2200 HSV-1 and HSV-2 IgG Assay vs. Predicate HSV 1 and 2 Immunoblot IgG

Similarities betweenComponents /Materials	BioPlex 2200 HSV-1 and HSV-2IgG Kit	Predicate HSV 1 and 2Immunoblot IgG
Reagents	Wash Solution, Sample Diluent.	Wash Buffer, Diluent.
Controls	Negative Control and multi-analyte Positive Control.	Negative Control andPositive/Cutoff Control.

Table 1: Similarities between reagents and materials

Table 2: Similarities between reagents with regard to function and use

Similarities betweenFunction and Use	BioPlex 2200 HSV-1 and HSV-2IgG Kit	Focus HerpesSelect 1 and 2Immunoblot IgG
Analyte Detection	Qualitative detection of IgGantibodies to HSV-1 and HSV-2.	Qualitative detection of IgGantibodies to HSV-1 and HSV-2.

Table 3: Differences between reagents and materials

Differences between Components / Materials	BioPlex 2200-HSV-1 and HSV-2 IgG Kit	Focus HerpesSelect 1 and 2 Immunoblot IgG
Solid Phase	Bead reagent - dyed antigen coated beads.	Treated nitrocellulose membrane strips containing antigen bands.
Reagents	Conjugate: Anti-human IgG / Phycoerythrin.	Conjugate: goat anti-human IgG / alkaline phosphatase, Blotting Powder, Substrate.
Sheath Fluid	Sheath Fluid is used to suspend the bead reagent and introduce it into the detector.	Not similar; not utilized in blot assays.
Calibrator(s)	Calibrators.	None.

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Differences betweenFunction and Use	BioPlex 2200 HSV-1 and HSV-2IgG Kit	Focus HerpesSelect 1 and 2Immunoblot IgG
Technique	Flow immunoassay.	Immunoblot.
Matrices	Serum and plasma.	Serum.

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Table 4: Differences between reagents with regard to function and use

PERFORMANCE SUMMARY

A. Expected Values

Prevalence

The observed prevalence and expected values for the BioPlex 2200 HSV-1 & HSV-2 IgG kit are presented by age and gender for serum samples from sexually active individuals where an HSV-1 test was ordered (N=289); sexually active individuals where an HSV-2 test was ordered (N=286); and for expectant mothers (N=399). Results are shown in Tables 5 - 11.

Table 5: Sexually Active Individuals With an HSV-1 Test Ordered: BioPlex 2200 HSV-1 IgG (N = 289)

Age in Years	Gender	Positive		Equivocal		Negative		Total
		N	%	N	%	N	%	N
18-20	F	6	85.7%	0	0.0%	1	14.3%	7
18-20	M	8	66.7%	0	0.0%	4	33.3%	12
21-30	F	15	62.5%	0	0.0%	9	37.5%	24
21-30	M	21	58.3%	0	0.0%	15	41.7%	36
31-40	F	19	86.4%	1	4.5%	2	9.1%	22
31-40	M	23	71.9%	1	3.1%	8	25.0%	32
41-50	F	17	81.0%	0	0.0%	4	19.0%	21
41-50	M	38	74.5%	1	2.0%	12	23.5%	51
51-60	F	8	61.5%	0	0.0%	5	38.5%	13
51-60	M	23	74.2%	2	6.5%	6	19.4%	31
61-70	F	11	68.8%	0	0.0%	5	31.3%	16
61-70	M	15	75.0%	0	0.0%	5	25.0%	20
71-80	F	1	50.0%	0	0.0%	1	50.0%	2
71-80	M	2	100%	0	0.0%	0	0.0%	2
81-89	F	0	0.0%	0	0.0%	0	0.0%	0
81-89	M	0	0.0%	0	0.0%	0	0.0%	0
Total		207	71.6%	5	1.7%	77	26.6%	289

Note: Due to rounding numbers across columns may not total 100%.

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Age in Years	Gender	Positive		Equivocal		Negative		Total
		N	%	N	%	N	%	N
18-20	F	2	50.0%	0	0.0%	2	50.0%	4
18-20	M	2	22.2%	0	0.0%	7	77.8%	9
21-30	F	10	38.5%	0	0.0%	16	61.5%	26
21-30	M	15	36.6%	0	0.0%	26	63.4%	41
31-40	F	9	69.2%	0	0.0%	4	30.8%	13
31-40	M	16	32.0%	1	2.0%	33	66.0%	50
41-50	F	9	52.9%	0	0.0%	8	47.1%	17
41-50	M	21	40.4%	0	0.0%	31	59.6%	52
51-60	F	7	46.7%	0	0.0%	8	53.3%	15
51-60	M	10	37.0%	0	0.0%	17	63.0%	27
61-70	F	4	50.0%	0	0.0%	4	50.0%	8
61-70	M	4	20.0%	0	0.0%	16	80.0%	20
71-80	F	0	0.0%	0	0.0%	0	0.0%	0
71-80	M	0	0.0%	0	0.0%	3	100%	3
81-89	F	0	0.0%	0	0.0%	1	100%	1
81-89	M	0	0.0%	0	0.0%	0	0.0%	0
Total		109	38.1%	1	0.4%	176	61.5%	286

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Table 6:Sexually Active Individuals With an HSV-2 Test Ordered: BioPlex 2200 HSV-2 IgG (N = 286)

Table 7: Sexually Active Individuals With an HSV-1 Test Ordered: BioPlex 2200 HSV-1 IgG and HSV-2 IgG Dual Positive (N = 289)

Age in Years	Gender	BioPlex 2200 HSV-1 & HSV-2 IgG Dual Positive		Total
		N	%	N
18-20	F	3	42.9%	7
18-20	M	3	25.0%	12
21-30	F	10	41.7%	24
21-30	M	10	27.8%	36
31-40	F	14	63.6%	22
31-40	M	12	37.5%	32
41-50	F	10	47.6%	21
41-50	M	9	17.6%	51
51-60	F	3	23.1%	13
51-60	M	8	25.8%	31
61-70	F	3	18.8%	16
61-70	M	5	25.0%	20
71-80	F	1	50.0%	2
71-80	M	0	0.0%	2
81-89	F	0	0.0%	1
81-89	M	0	0.0%	0
Total		91	31.5%	289

BioPlex 2200 HSV-1 and HSV-2 IgG 510(k) Summary (5-1-09)

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Table 8. Sexually Active Individuals With an HSV-2 Test Ordered: BioPlex 2200 HSV-1 IgG and HSV-2 IgG Dual Positive (N = 286)

Age in Years	Gender	BioPlex 2200 HSV-1 & HSV-2 IgGDual Positive		Total
		N	%	N
18-20	F	1	25.0%	4
18-20	M	1	11.1%	9
21-30	F	7	26.9%	26
21-30	M	9	22.0%	41
31-40	F	4	30.8%	13
31-40	M	10	20.0%	50
41-50	F	6	35.3%	17
41-50	M	13	25.0%	52
51-60	F	4	26.7%	15
51-60	M	7	25.9%	27
61-70	F	4	50.0%	8
61-70	M	4	20.0%	20
71-80	F	0	0.0%	0
71-80	M	0	0.0%	3
81-89	F	0	0.0%	1
81-89	M	0	0.0%	0
Total		70	24.5%	286

Table 9: Expectant Mothers: BioPlex 2200 HSV-1 IgG (N = 399)

	BioPlex 2200 KSV-1 IgG
Age in Years	Positive			Equivocal	Negative	Total
	- N	% -	N	= %-		~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~	: :
14-20	35	58.3%	0	0.04%	ર્ટ	41.7%	60
21-30	1 33	70.7%	2	1.168	રૂ રે	28.2%	488
31-40	ರೆದಿ	76.0%	0	0.0%	31	24.0%	123
41-50	21	100%	0	0.0%	0	0.0%	24
Unknown	1	100%	0	0.04%	0	0.04%	1
Total	288	72.2%	2	0.5%	100	27.3%	ਤਰ੍ਹੈ

BioPlex 2200 HSV-1 and HSV-2 IgG 510(k) Summary (5-1-09);

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	BioPlex 2200 HSV-2 IgG
Age in Years		Posítive		Equivocal	Negative	Total
	મ	శా	N	વેરુ	હિ	તેર	N
14-20	12	20.0%	0	છે.લીજુ	ਕਤ	80.0%	60
21-30	చేస్తే చేస్తున్నారు. ఈ చేస్తున్నారు. ఈ ప్రస్తుంది. ఈ ప్రదేశాల ప్రస్తుంది. ఈ ప్రధాన ప్రదేశాల ప్రస్తుంది. ప్రధాన ప్రదేశాల ప్రధాన ప్రత్యాలను ప్రస్తుంది. ప్రధానం విశ్రమించి విద్	35.1%	D	0.0%	122	64.00%	188
31-40	દક	52.7%	D	0.0%	61	47 .39%	124
41-50	11	52.4%	0	0.0%	ને પા	47.64%	24
Unknosan	ប្រ	0.0%	0	0.0%	-	4 00%	1
【otal	157	39.34%	0	0.0%	242	60.7%	300

Table 10: Expectant Mothers: BioPlex 2200 HSV-2 IgG (N = 399)

	Table 11: Expectant Mothers: BioPlex 2200 HSV-1 IgG & HSV-2 IgG Dual Positive (N = 399)

Age in Years	BioPlex 2200 HSV-1 & HSV-2 IgG Dual Positive	N	%
14-20	9	15.0%	60
21-30	46	24.5%	168
31-40	56	43.4%	129
41-50	11	52.4%	21
Unknown	0	0.0%	1
Total	122	30.6%	399

Prevalence of HSV-1 or HSV-2 infection may vary by geographical area, age, or gender. The predictive value of the assay is dependent on the prevalence of HSV infection. Tables 12 - 14 present the observed prevalence and predictive values as well as hypothetical predictive values for decreasing prevalence rates. The hypothetical HSV-1 predictive values presented are based on BioPlex 2200 HSV-1 IgG 97.6% sensitivity and 90.1% specificity in sexually active individuals with an HSV-1 test ordered and 96.3% sensitivity and 99.0% specificity in expectant mothers. The hypothetical HSV-2 predictive values presented are based on BioPlex 2200 HSV-2 IgG sensitivity of 90.6% and specificity 98.2 % in sexually active adults with an HSV-2 test ordered and a 96.9% sensitivity and 100% specificity in expectant mothers.

Population	N	BioPlex 2200 HSV-1 IgG			BioPlex 2200 HSV-2 IgG
		Prevalence	PPV	NPV	Prevalence	PPV	NPV
Sexually Active Individuals withan HSV-1 Test ordered	289	71.6%	96.2%	93.6%	N/A	N/A	N/A
Sexually Active Individuals withan HSV-2 Test ordered -	286	N/A	N/A	N/A	38.1%	97.3%	93.8%
Expectant Mothers	399	72.2%	99.7%	90.1%	39.3%	100%	97.9%

Table 12: Summary of Observed Prevalence, Rositive Predictive Value (PPV), Negative Predictive Value (NPV)

BioPlex 2200 HSV-1 and HSV-2 IgG 510(k) Summary (5-1-09);,,,,,,,,,,,,,,,,,,,,, 154 min min an HSV

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Image /page/8/Picture/9 description: The image shows the logo for BIO-RAD. The logo is in white text on a black background. The text is bold and sans-serif. The logo is simple and easy to read.

、・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

Table 13: HSV-1 Hypothetical Predictive Values by Prevalence

Prevalence	Sexually Active Individuals		Expectant Mothers
	PPV	NPV	PPV	NPV
80%	97.5%	90.4%	99.7%	87.0%
70%	95.8%	94.1%	99.6%	92.0%
60%	93.7%	96.2%	99.3%	94.7%
50%	90.8%	97.4%	99.0%	96.4%
40%	86.8%	98.3%	98.5%	97.6%
30%	80.9%	98.9%	97.6%	98.4%
25%	76.7%	99.1%	97.0%	98.8%
20%	71.1%	99.3%	96.0%	99.1%
15%	63.5%	99.5%	94.4%	99.3%
10%	52.3%	99.7%	91.5%	99.6%
5%	34.2%	99.9%	83.5%	99.8%

;
;

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ﻨﻪ

Table 14: HSV-2 Hypothetical Predictive Values by Prevalence

. .

	Sexually Active Individuals		Expectant Mothers
Prevalence	bbh	NPV	РУУ	NPV
કોનો જો	ਰੇਹੋ ਦੇ ਫੇਲ	72.3%	100%	80.0%
70%	99.2%	81.7%	100%	03.3%
દિવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત	08.7%	87.40%	100%	05.6%
રેપેન્ડ	08.1%	01.3%	400000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000	97.04%
40%	07.19%	04.096	નાવાદન્દ્ર	08.0%
30% -	95.6%	08.196	- 100% --	98.7%
25%	04.49%	46.99%	100%	gg.0%
20%	92.6%	97.7%	100%	તેવી જેવી જેવી
15%	80.0%	08.34%	100000	09.5%
10%	84.84%	98.0%	100%	09.7%
కోళ్ళా	72.6%	00 5%	100%	da Bar

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------"

BioPlex 2200 HSV-1 and HSV-2 IgG 510(k) Summary (5-1-09)

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Image /page/9/Picture/0 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is in black and white and features the company name in a bold, sans-serif font. The words "BIO" and "RAD" are separated by a plus sign.

B. Comparative Testing

Table 15 summarizes the performance of the BioPlex 2200 HSV-1 and HSV-2 IgG kit observed during comparative testing. Refer to Tables 16 - 23 for detailed performance testing summaries.

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

Population	BioPlex 2200 HSV-1 IgG				BioPlex 2200 HSV-2 IgG
	% Sensitivity	95% Confidence Interval	% Specificity	95% Confidence Interval	% Sensitivity	95% Confidence Interval	% Specificity	95% Confidence Interval
Sexually ActiveIndividuals With anHSV-1 Test Ordered(N = 289)	97.6%(202/207)	94.5 -99.0%	90.1%(73/81)	81.7 -94.9%	N/A	N/A	N/A	N/A
Sexually ActiveIndividuals With anHSV-2 Test Ordered(N = 286)	N/A	N/A	N/A	N/A	90.6%(106/117)	83.9 -94.7%	98.2%(166/169)	94.9 -99.4%
Expectant Mothers(N = 399)	96.3%(287/298)	93.5 -97.9%	99.0%(100/101)	94.6 -99.8%	96.9%(157/162)	93.0 -98.7%	100%(237/237)	98.4 -100%
CDC Panel(N = 100)	100%*(50/50)	92.8 -100%	96.0%**(48/50)	86.5 -98.9%	100%*(50/50)	92.8 -100%	100%**(50/50)	92.8 -100%
Low Prevalence[16-19 years](N = 200)	93.3%(97/104)	86.7 -96.7%	97.9%(94/96)	92.7 -99.4%	N/A	N/A	97.8%(181/185)	94.6 -99.2%

Table 15: Summary Performance of the BioPlex 2200 HSV-1 and HSV-2 IgG Assay

% Positive Agreement

** % Negative Agreement

N/A = Not applicable

Page 10 of 17

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BORRAD

Performance of the BioPlex 2200 HSV-1 & HSV-2 IgG kit in the intended use populations was tested against a commercially available immunoblot test in a prospective study conducted at a total of 3 U.S. clinical sites. For purposes of sensitivity calculations, the BioPlex 2200 equivocal results were assigned to the opposite clinical interpretation than that of the corresponding immunoblot result. Likewise, immunoblot equivocal results were assigned to the opposite clinical interpretation than that of the BioPlex 2200 result.

Performance in Sexually Active Individuals -----------------------------------------------------------------------------------------------------------------------------------The sensitivity and specificity of the HSV-1 & HSV-2 IgG kit was assessed using remnant serum samples from sexually active individuals where an HSV-1 test was ordered (N=289) and sexually active individuals where an HSV-2 test was ordered (N=286). Samples were tested at 3 U.S. clinical sites. Combined results from all sites are shown in Tables 16 & 17.

		BioPlex 2200 HSV-1 IgG
		Positive	Equivocal	Negative	Total	% Sensitivity	95% Confidence Interval	% Specificity	95% Confidence Interval
CommerciallyAvailable HSV-1 IgGImmunoblot	Positive	202	1	1	204	97.6%(202/207)	(94.5 - 99.0%)	90.1%(73/81)	(81.7 - 94.9%)
	Equivocal	1	1	3	5
	Negative	4	3	73	80
	Total	207	5	77	289

Table 16: Sexually Active Individuals With an HSV-1 Test Ordered: BioPlex 2200 HSV-1 IgG vs.Immunoblot (N = 289)

Table 17: Sexually Active Individuals With an HSV-2 Test Ordered: BioPlex 2200 HSV-2 IgG vs. Immunoblot (N = 286)

		BioPlex 2200 HSV-2 IgG
		Positive	Equivocal	Negative	Total	% Sensitivity	95% Confidence Interval	% Specificity	95% Confidence Interval
CommerciallyAvailable HSV-2 IgGImmunoblot	Positive	106	1	10	117	90.6%(106/117)	(83.9 - 94.7%)	98.2%(166/169)	(94.9 - 99.4%)
	Equivocal	0	0	0	0
	Negative	3	0	166	169
	Total	109	1	176	286

BioPlex 2200 HSV-1 and HSV-2 IgG 510(k) Summary (5-1-09)" Th

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Performance in Expectant Mothers

The sensitivity and specificity of the HSV-1 & HSV-2 IgG kit was assessed using remnant serum samples from expectant mothers (N=399). Results are shown in Tables 18 & 19.

	BioPlex 2200 HSV-1 IgG
	Positive	Equivocal	Negative	Total	Positive (+)% Agreement	95%ConfidenceInterval	Negative (-)% Agreement	95%ConfidenceInterval
CommerciallyAvailable HSV-1 IgGImmunoblot	Positive	287	2	8	297	96.3%(287/298)	(93.5 - 97.9%)	99.0%(100/101)	(94.6 - 99.8%)
	Equivocal	0	0	1	1
	Negative	1	0	100	101
	Total	288	2	109	399

Table 18: Expectant Mothers: BioPlex HSV-1 IgG vs. Immunoblot (N = 399)

		BioPlex 2200 HSV-2 IgG
Table 19: Expectant Mothers: BioPlex HSV-2 IgG vs. Immunoblot (N = 399)		Positive	Equivocal	Negative	Total	Positive (+)% Agreement	95%ConfidenceInterval	Negative (-)% Agreement	95%ConfidenceInterval
CommerciallyAvailable HSV-2 IgGImmunoblot	Positive	157	0	4	161	96.9%(157/162)	(93.0 - 98.7%)
	Equivocal	0	0	1	1			100%(237/237)	(98.4 - 100%)
	Negative	0	0	237	237
	Total	157	0	242	399

ant Mothers: BioPlex HSV-2 InG vs_Im 2001 munablat IN -

•

. . . . . -: - - -- --- * BioPlex 2200 HSV-1 and HSV-2 IgG 510(k) Summary (5-1-09)

: ............................................................................................................................................................................

Page 12 of 17

4 ነው ትርጉ

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Agreement with CDC Panel

The performance of the BioPlex 2200 HSV-1 & HSV-2 IgG kil was assessed using a masked, well characterized HSV serum panel from the CDC. The panel consists of 24% HSV-1 and HSV-2 dual-positive samples, 50% HSV-1 positive and 50% HSV-1 negative samples and 48% HSV-2 positive and 52% HSV-2 negative samples. The results are presented to convey further information on the performance of the test kit and do not imply endorsement of the assay by the CDC. Results are shown in Tables 20 & 21.

Table 20: BioPlex 2200 HSV-1 IgG vs. CDC HSV Panel (N = 100)
--------------------------------------------------------------	--	--

		BioPlex 2200 HSV-1 IgG
		Positive	Equivocal	Negative	Total	Positive (+)% Agreement	95%ConfidenceInterval	Negative (-)% Agreement	95%ConfidenceInterval
CDC HSV-1Result	Positive	50	0	0	50	100%(50/50)	(92.8 - 100%)	96.0%(48/50)	(86.5 - 98.9%)
	Negative	0	2	48	50
	Total	50	2	48	100

Table 21: BioPlex 2200 HSV-2 IgG vs. CDC HSV Panel (N = 100)
--------------------------------------------------------------	--	--

CDC HSV-2 Result	Positive	Negative	Total	Positive (+) % Agreement	95% Confidence Interval	Negative (-) % Agreement	95% Confidence Interval
Positive	50	0	50
Negative	0	50	50	100% (50/50)	(92.8 - 100%)	100% (50/50)	(92.8 - 100%)
Total	50	50	100

BioPlex 2200 HSV-1 and HSV-2 IgG 510(k) Summary (5-1-09)

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Performance in a Low Prevalence Population

The sensitivity and specificity of the HSV-1 & HSV-2 IgG kit was assessed using remnant serum samples from a low-prevalence population, collected in a non-STD setting, in people age 16-19 (N=200). Samples were tested at 2 U.S. clinical testing sites. Results are shown in Tables 22 & . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23.

Table 22: Low-Prevalence Population, Non-STD Setting: BioPlex 2200 HSV-1 IgG vs.Immunoblot (N = 200)

		BioPlex 2200 HSV-1 IgG
		Positive	Equivocal	Negative	Total	Positive (+)% Agreement	95%ConfidenceInterval	Negative (-)% Agreement	95%ConfidenceInterval
CommerciallyAvailable HSV-1 IgGImmunoblot	Positive	97	1	4	102	93.3%(97/104)	(86.7 - 96.7%)
	Equivocal	0	0	2	2			97.9%(94/96)	(92.7 - 99.4%)
	Negative	2	0	94	96
	Total	99	1	100	200

Table 23: Low-Prevalence Population, Non-STD Setting: . . - --BioPlex 2200 HSV-2 IgG vs. Immunoblot (N = 200)

		BioPlex 2200 HSV-2 IgG				% Sensitivity	95% Confidence Interval	% Specificity	95% Confidence Interval
		Positive	Equivocal	Negative	Total
CommerciallyAvailable HSV-2 IgGImmunoblot	Positive	11	0	2	13	73.3%(11/15)	N/A	97.8%(181/185)	(94.6 - 99.2%)
	Equivocal	0	0	2	2
	Negative	3	1	181	185
	Total	14	1	185	200

N/A = Not applicable. There are insufficient positive samples to calculate a stailstically meaningful % sensitivity for the low-prevalence population.

BioPlex 2200 HSV-1 and HSV-2 IgG 510(k) Summary (5-1-09)

Page 14 of 17

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C. Reproducibility Studies

To assess reproducibility of each of the assays in the BioPlex 2200 HSV-1 & HSV-2 IgG kit, a reproducibility panel was prepared at Bio-Rad Laboratories. The reproducibility panel consisted of 8 panel members and the HSV-1 & HSV-2 IgG positive control. The reproducibility panel members were made from diluted patient sera. Reproducibility testing was performed at 2 external evaluation sites and internally at Bio-Rad Laboratories.using 3 lots of the HSV-1 & HSV-2 IgG Reagent Pack, 3 lots of the HSV-1 & HSV-2 IgG Calibrator set and 3 lots of the HSV-1 & HSV-2 IgG Control set (one lot at each site). Each of the reproducibility panel members were tested in duplicate on two runs per day, for 5 days, on 3 lots (2 replicates x 2 runs x 5 days x 3 lots = 60 replicates per panel member). The data were analyzed for intra-assay and inter-assay reproducibility according to the principles described in the Clinical Laboratory Standards Institute (CLSI) guidance EP15-A2 (Vol. 25, No. 17). The standard deviation (SD) and prevent coefficient of variation (% CV) were calculated. Results are shown in Tables 24 & 25.

HSV-1 IgG PanelMembers	SampleN	MeanAI		Within-Run		Between-Run		Between-Day		Between-Site*		Total
			SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
High Positive	60	3.6	0.159	4.4%	0.000	0.0%	0.178	4.9%	0.081	2.2%	0.252	6.9%
High Positive	60	3.8	0.132	3.5%	0.095	2.5%	0.125	3.3%	0.413	10.9%	0.461	12.2%
Low Positive	60	1.5	0.090	6.2%	0.000	0.0%	0.073	5.0%	0.167	11.4%	0.203	13.9%
Low Positive	60	1.3	0.058	4.5%	0.034	2.7%	0.058	4.5%	0.113	8.9%	0.144	11.3%
Near Cutoff	60	1.0	0.050	5.2%	0.018	1.9%	0.047	4.9%	0.128	13.4%	0.146	15.3%
Near Cutoff	60	0.9	0.047	5.1%	0.052	5.6%	0.030	3.2%	0.099	10.7%	0.124	13.5%
High Negative	59**	0.6	0.013	2.3%	0.000	0.0%	0.018	3.2%	0.053	9.5%	0.058	10.3%
High Negative	60	0.6	0.034	5.9%	0.000	0.0%	0.023	3.9%	0.024	4.2%	0.048	8.3%
Positive Control	60	3.0	0.127	4.2%	0.092	3.0%	0.108	3.5%	0.137	4.5%	0.235	7.7%

Table 24: Reproducibility: BioPlex 2200 HSV-1 IgG Serum
---------------------------------------------------------	--	--

*Between site variance includes between lot variance.

** One replicate lost due to laboratory error.

Table 25: Reproducibility: BioPlex 2200 HSV-2 IgG Serum
---------------------------------------------------------	--	--

HSV-2 IgG PanelMembers	SampleN	MeanAI	Within-Run		Between-Run		Between-Day		Between-Site*		Total
			SD	%CV	SD	%CV	SD	%CV	SD	%CV	SD	%CV
High Positive	59**	3.0	0.149	5.0%	0.124	4.1%	0.000	0.0%	0.155	5.2%	0.249	8.2%
High Positive	60	3.5	0.121	3.4%	0.135	3.8%	0.093	2.6%	0.226	6.4%	0.304	8.6%
Low Positive	60	1.8	0.111	6.1%	0.000	0.0%	0.074	4.1%	0.145	7.9%	0.197	10.7%
Low Positive	60	1.5	0.061	4.0%	0.047	3.1%	0.059	3.9%	0.117	7.8%	0.151	10.1%
Near Cutoff	60	1.2	0.052	4.3%	0.034	2.9%	0.059	4.9%	0.063	5.3%	0.106	8.9%
Near Cutoff	60	1.2	0.034	2.9%	0.072	6.0%	0.040	3.4%	0.069	5.8%	0.113	9.4%
High Negative	60	0.7	0.039	5.2%	0.000	0.0%	0.037	5.1%	0.058	7.9%	0.079	10.7%
High Negative	60	0.6	0.037	6.3%	0.000	0.0%	0.029	5.0%	0.027	4.7%	0.054	9.3%
Positive Control	60	2.8	0.097	3.4%	0.092	3.3%	0.088	3.1%	0.056	2.0%	0.170	6.0%

*Between site variance includes between lot variance.

** One replicate lost due to laboratory error.

..............................................................................................................................................................................

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D. Precision Studies

A Precision panel, consisting of 8 panel members was prepared by Bio-Rad Laboratories. For each analyte, 2 of the 8 panel members had high positive levels of the antibodies, 2 had low positive levels of the antibodies, and 2 had antibody levels near the cutoff; additionally there were 2 high negative panel members. Precision testing was performed at Bio-Rad Laboratories on one lot of the HSV-1 & HSV-2 IgG Reagent Pack, one lot of the HSV-1 & HSV-2 IgG Calibrator Set and one lot of the HSV-1 & HSV-2 IgG Control Set. Each of the 8 panel members was tested in duplicate (x2) on 2 runs per day for 20 days (2 times x 2 runs x 20 days = 80 replicates per panel) member). The data were analyzed for intra-assay and inter-assay precision according to the principles described in the Clinical Laboratory Standards Institute guidance EP5-A2, revised November 2004. The standard deviation (SD) and percent coefficient of variation (%CV) were calculated. Results are shown in Tables 26 & 27.

HSV-1 IgGPanel Members	SampleN	MeanAI	Within Run		Between Run		Between Day		Total
			SD	%CV	SD	%CV	SD	%CV	SD	%CV
High Positive	80	3.2	0.14	4.4%	0.16	5.0%	0.00	0.0%	0.21	6.6%
High Positive	80	3.6	0.16	4.3%	0.08	2.2%	0.10	2.7%	0.20	5.5%
Low Positive	80	1.3	0.05	3.7%	0.02	1.5%	0.03	2.5%	0.06	4.7%
Low Positive	80	1.7	0.08	4.9%	0.09	5.5%	0.03	1.7%	0.13	7.6%
Near Cutoff	80	1.0	0.03	2.7%	0.03	3.4%	0.03	2.9%	0.05	5.2%
Near Cutoff	80	1.1	0.04	3.9%	0.03	2.7%	0.02	2.2%	0.06	5.2%
High Negative	80	0.7	0.04	5.8%	0.00	0.0%	0.01	2.0%	0.04	6.1%
High Negative	80	0.5	0.02	4.5%	0.02	3.2%	0.01	2.6%	0.03	6.1%

Table 26: Precision: BioPlex 2200 HSV-1 IgG Serum

Table 27: Precision: BioPlex 2200 HSV-2 IgG Serum

HSV-2 IgGPanel Members	SampleN	MeanAI	Within Run		Between Run		Between Day		Total
			SD	%CV	SD	%CV	SD	%CV	SD	%CV
High Positive	80	5.5	0.17	3.0%	0.20	3.6%	0.03	0.5%	0.26	4.8%
High Positive	80	4.4	0.17	3.8%	0.07	1.5%	0.11	2.4%	0.21	4.8%
Low Positive	80	1.8	0.09	5.2%	0.02	1.2%	0.05	2.9%	0.11	6.1%
Low Positive	80	2.4	0.09	3.8%	0.09	3.6%	0.09	3.6%	0.15	6.3%
Near Cutoff	80	1.3	0.05	3.8%	0.04	2.7%	0.02	1.4%	0.06	4.9%
Near Cutoff	80	1.1	0.06	5.2%	0.04	3.2%	0.02	2.1%	0.07	6.5%
High Negative	80	0.8	0.05	5.8%	0.03	3.4%	0.01	1.3%	0.05	6.8%
High Negative	80	0.6	0.03	4.6%	0.00	0.0%	0.02	2.9%	0.03	5.4%

BioPlex 2200 HSV-1 and HSV-2 IgG 510(k) Summary (5-1-09)

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E. Cross-Reactivity

A cross-reactivity study was performed to determine if samples from various disease states and other potentially cross-reacting agents interfere with test results when tested with the BioPlex 2200 HSV-1 & HSV-2 IgG kit. Samples known to be positive for one of the twenty potential crossreactants listed in the table below were evaluated with the BioPlex 2200 HSV-1 & HSV-2 IgG assays. All samples were pre-tested by a commercially available HSV-1 and HSV-2 IgG immunoblot assay and only those that tested negative by the immunoblot assay were further tested by the BioPlex 2200 HSV-1 & HSV-2 IgG kit. Table 28 summarizes negative agreement between the BioPlex 2200 HSV-1 & HSV-2 IgG assays and the corresponding commercially available HSV-1 and HSV-2 IgG immunoblot assay within each of the twenty cross-reactant panels. The results demonstrate that the various disease state samples evaluated do not crossreact with the 2 antigens in the BioPlex 2200.HSV-1 & HSV-2 IgG kit.

Potential Cross-Reactant	N	HSV-1 IgGBioPlex 2200Negative Agreement	N	HSV-2 IgGBioPlex 2200Negative Agreement
ANA IgG	5	5/5	10	10/10
Candida albicans	8	8/8	9	9/9
CMV IgG	8	8/8	8	8/8
E. coli	2	2/2	8	8/8
Toxoplasma gondii IgG	8	8/8	8	8/8
HCV IgG	7	7/7	10	9/10*
VZV IgG	10	10/10	10	10/10
Rubella IgG	6	6/6	7	7/7
HBs Antibody	8	8/8	9	9/9
EBV-VCA IgG	7	7/7	7	7/7
Syphilis IgG	4	4/4	7	7/7
N. gonorrhea	4	4/4	10	10/10
HPV IgG	10	10/10	10	10/10
C. trachomatis	5	5/5	9	9/9
HIV	10	10/10	5	5/5
Rheumatoid Factor	7	7/7	9	9/9
Bacterial Vaginosis
- Bacteroides sp.	N/A	N/A	6	4/6
- Trichonomis	10	10/10	10	10/10
- Mobiluncus sp.	1	1/1	4	4/4
- Gardenella vaginalis	10	10/10	10	10/10

Table 28: Cross-Reactivity

One (1) HCV sample was identified as low positive for HSV-2 by the BioPlex 2200 HSV-2 IgG assay with an Al value of 1.3.

At Two (2) Bacteroides sp. samples were identified HSV-2 equivocal and low positive with Al values of 1.0 and 1.1, respectively, by the BioPlex 2200 HSV-2 IgG assay.

N/A = Not available

BioPlex 2200 HSV-1 and HSV-2 IgG 510(k) Summary (5-1-09)

Page 17 of 17

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/17/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, services, and people. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY - 8 2009

David V. Bhend Regulatory Affairs Representative Bio-Rad Laboratories 6565 185th Ave. NE Redmond, WA 98052

K090409 Re:

R090407
Trade/Device Name: BioPlex™ 2200 HSV-1 and HSV-2 IgG Kit Regulation Number: 21 CFR 866.3305 Regulation Name: Herpes simplex virus serological reagents Regulatory Class: Class II Product Code: MXJ,MYF Dated: February 17, 2009 Received: February 18, 2009

Dear Mr. Bhend:

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 with the provisions of approval application (PMA). You may, therefore, market the approvision of a provisions of the Act. The Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, provisions of the roo ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations (1 wa t), it may be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 I oderal agencies: "1 on ind listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

Enclosure

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 ' (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sally attym

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Indication for Use

510(k) Number (if known): K090409

Device Name: BioPlex 2200 HSV-1 and HSV-2 IgG kit on the BioPlex 2200 Multi-Analyte Detection System

Indication For Use:

The BioPlex 2200 HSV-1 & HSV-2 IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.

Prescription Use
(21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Ure Schuf

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K070404

Page 1 of 1

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).