Predicate Devices

Not Found

Reference Devices

HerpeSelect2 ELISA IgG

AI/ML (Artificial Intelligence / Machine Learning)

No
The document mentions "software" but provides no indication of AI/ML capabilities. The performance studies focus on agreement with manual calculations and traditional metrics like sensitivity and specificity, not on AI/ML model performance. There is no mention of training or test sets for an AI/ML model.

Therapeutic

No.
This device is for diagnostic purposes, specifically for detecting antibodies to HSV-1 and HSV-2 infections, not for treating any condition.

Diagnostic

Yes

Explanation: The "Intended Use" section explicitly states that the device is "intended for qualitatively detecting the presence or absence of human IgG antibodies to HSV-1 and HSV-2...as an aid for presumptively diagnosing HSV-1 and HSV-2 infection." This clearly indicates its role in diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "multiplexed immunoassay" and that the "Test principle is identical to the predicate device," which is an "Immunoblot IgG." This indicates a physical assay component is involved in detecting antibodies, not just software processing data. The software is likely used for calculating indexes or interpreting results from the immunoassay.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The device is intended for "qualitatively detecting the presence or absence of human IgG antibodies to HSV-1 and HSV-2 in human sera." This clearly indicates it is used to test a sample taken from the human body (sera) in vitro (outside the body) to provide diagnostic information.
Device Description: It is described as a "multiplexed immunoassay for qualitatively detecting and differentiating human IgG antibodies to HSV-2." Immunoassays performed on biological samples are a common type of IVD.
Performance Studies: The document details extensive performance studies using human serum samples to evaluate the device's accuracy (sensitivity, specificity) in detecting antibodies. This is characteristic of the validation required for IVD devices.
Predicate Device: The mention of a "predicate device" (HerpeSelect 1 and 2 Immunoblot IgG) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as comparison to a legally marketed predicate is a common pathway for IVD approval.
Exclusions: The statement that the test is "not intended for donor screening or for self-testing" and that performance has not been established for "point of care facility" further reinforces its intended use as a clinical laboratory-based IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Focus Diagnostics Plexus™ HerpeSelect® HSV 1 and 2 IgG (with software) is intended for qualitatively detecting the presence or absence of human IgG antibodies to HSV-1 and HSV-2 in human sera. The test is indicated for pregnant women and sexually active adults, as an aid for presumptively diagnosing HSV-1 and HSV-2 infection. The predictive value of a positive or negative result depends on the population's prevalence and the pretest likelihood of HSV-1 and HSV-2 infection. The test is not intended for donor screening or for self-testing. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, for testing of immunocompromised patients, for use by a point of care facility or for use with automated equipment.

Product codes

MXJ, MYF

Device Description

The Focus Diagnostics Plexus™ HerpeSelect® HSV 1 and 2 IgG (with software) is a multiplexed immunoassay for qualitatively detecting and differentiating human IgG antibodies to HSV-2. Test principle is identical to the predicate device.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

The test is indicated for pregnant women and sexually active adults.

Intended User / Care Setting

The test is not intended for donor screening or for self-testing. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, for testing of immunocompromised patients, for use by a point of care facility or for use with automated equipment.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Studies to Validate Plexus™ HerpeSelect® HSV 1 and 2 IgG (with software): Testing was done at two external sites and one internal site to confirm that assay results obtained using Plexus Software are identical to results calculated manually using the instrument (Luminex) raw data.
Sample size: 600
Data Source: Not specified beyond internal/external sites.
Annotation Protocol: Manual calculation using Luminex raw data.

Sensitivity and Specificity with Pregnant Women (n = 300):
Sample size: 300
Data Source: Focus (n=150) and an external investigator (n=150), sera collected in the Pacific Northwestern United States. The sera were sequentially submitted to the laboratory, archived, and masked.
Annotation Protocol: Gold-standard reference method was the Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG for calculation of sensitivity and specificity.

Reactivity with Sexually Active Adults (n = 300):
Sample size: 300
Data Source: Focus (n=150) and an external investigator (n=150), sera collected in the Pacific Northwestern United States. The sera were sequentially submitted to the laboratory, archived, and masked.
Annotation Protocol: Gold-standard reference method was the Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG for calculation of sensitivity and specificity.

Agreement with CDC Panel (n = 100):
Sample size: 100 (50 test sera with duplicates)
Data Source: Serum panel obtained from the CDC.
Annotation Protocol: Not explicitly stated, but results are compared to CDC results.

Specificity with a Low Prevalence Population (n = 77):
Sample size: 77
Data Source: Focus selected sera from patients aged 18 and 19 years, submitted to a clinical laboratory in Southern California from states having a history of low sexually transmitted disease prevalence. Sera for sexually transmitted diseases, herpesvirus testing, and tests indicating immunocompromised were excluded. The sera were sequentially selected, archived and masked.
Annotation Protocol: HerpeSelect Plexus results were compared to the Focus HerpeSelect 1 and 2 Immunoblot IgG.

Cross-reactivity (n = 51):
Sample size: 51 (37 in "HSV ELISA dual negative" group, 14 in "HSV ELISA mixed sero-reactivity" group)
Data Source: Samples that were sero-negative/positive with HerpeSelect-1 ELISA IgG and HerpeSelect 2 ELISA IgG, and sero-positive by at least one of FDA cleared CMV ELISA IgG, home brew VZV ACIF, or FDA cleared EBV VCA IgG.
Annotation Protocol: Not explicitly stated but involves comparison to results from other ELISA assays.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

1. Studies to Validate Plexus™ HerpeSelect® HSV 1 and 2 IgG (with software)

Study Type: Agreement study of software calculated index vs. manually calculated index.
Sample Size: 600
Key Results: 100% agreement between software and manually calculated indexes for HSV-1 and HSV-2.
- HSV-1 Pos: 161/161 (100% agreement; 95% CI: 0.977 - 1.00)
- HSV-1 Eqv: 4/4 (100% agreement; 95% CI: 0.398 - 1.00)
- HSV-1 Neg: 134/134 (100% agreement; 95% CI: 0.973 - 1.00)
- HSV-2 Pos: 139/139 (100% agreement; 95% CI: 0.974 - 1.00)
- HSV-2 Eqv: 7/7 (100% agreement; 95% CI: 0.590 - 1.00)
- HSV-2 Neg: 153/153 (100% agreement; 95% CI: 0.976 - 1.00)

2. Summary of Previous Studies for Plexus™ HerpeSelect® HSV 1 and 2 IgG (manual calculation)

Study Type: Performance characteristics including specificity, sensitivity, CDC panel agreement, low prevalence population agreement, cross-reactivity, and reproducibility.

3. Sensitivity and Specificity with Pregnant Women

Study Type: Clinical performance study.
Sample Size: 300
Key Results:
- HSV-1 Sensitivity: 96.5% (164/170); 95%CI 92.5-98.7%
- HSV-1 Specificity: 92.2% (118/128); 95%CI 86.1-96.2%
- HSV-2 Sensitivity: 94.3% (115/122); 95%CI 88.5-97.7%
- HSV-2 Specificity: 95.5% (168/176); 95%CI 91.2-98.0%

4. Reactivity with Sexually Active Adults

Study Type: Clinical performance study.
Sample Size: 300
Key Results:
- HSV-1 Sensitivity: 91.0% (142/156); 95%CI 85.4-95.0%
- HSV-1 Specificity: 96.5% (137/142); 95%CI 92.0-98.9%
- HSV-2 Sensitivity: 96.3% (105/109); 95%CI 90.9-99.0%
- HSV-2 Specificity: 97.4% (184/189); 95%CI 93.9-99.1%

5. Agreement with CDC Panel

Study Type: Panel testing confirming agreement with characterized serum panel.
Sample Size: 100 (50 unique samples with duplicates)
Key Results:
- HSV-1 positive samples: 100% (54/54) correctly identified.
- HSV-2 positive samples: 100% (36/36) correctly identified.
- Double positive samples: 100% (22/22) correctly identified.
- Double negative samples: 100% (32/32) correctly identified.
- CDC Panel Reproducibility: All paired sera correctly identified (100%).

6. Specificity with a Low Prevalence Population

Study Type: Specificity study.
Sample Size: 77
Key Results:
- HSV-1 Sensitivity: 96.4% (27/28); 95%CI 81.6-99.9%
- HSV-1 Specificity: 97.9% (46/47); 95%CI 88.7-99.9%
- HSV-2 Sensitivity: 75.0% (3/4); 95%CI 19.4-99.4%
- HSV-2 Specificity: 100% (71/71); 95%CI 94.9-100%

7. Cross-reactivity

Study Type: Cross-reactivity study with two groups: "HSV ELISA dual negative" (n=37) and "HSV ELISA mixed sero-reactivity" (n=14) for CMV, VZV, and EBV.
Sample Size: 51
Key Results:
- CMV IgG +: HSV-1 positive 5.0% (1/20), HSV-2 positive 0.0% (0/27).
- VZV IgG +: HSV-1 positive 3.0% (1/33), HSV-2 positive 2.9% (1/34).
- EBV IgG +: HSV-1 positive 3.1% (1/32), HSV-2 positive 3.2% (1/31).

8. Inter-laboratory Reproducibility and Inter/Intra-assay Reproducibility

Study Type: Reproducibility study (inter-laboratory, inter-assay, intra-assay).
Sample Size: 2 laboratories, 11 samples, triplicate, 5 different days.
Key Results:
- HSV-1 Plexus IgG Intra-assay %CV: Range 3.6 - 10.0
- HSV-1 Plexus IgG Inter-assay %CV: Range 7.4 - 213.1 (with outliers)
- HSV-2 Plexus IgG Intra-assay %CV: Range 2.6 - 11.5
- HSV-2 Plexus IgG Inter-assay %CV: Range 7.7 - 334.2 (with outliers)

9. Inter-Lot Reproducibility

Study Type: Reproducibility study using three separate lots.
Sample Size: 11 samples, triplicate.
Key Results:
- HSV-1 Inter-Lot %CV: Range 5.8 - 50.6
- HSV-2 Inter-Lot %CV: Range 4.8 - 50.9

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Pregnant Women (n = 300):

HSV-1 Sensitivity: 96.5% (164/170)
HSV-1 Specificity: 92.2% (118/128)
HSV-2 Sensitivity: 94.3% (115/122)
HSV-2 Specificity: 95.5% (168/176)

Sexually Active Adults (n = 300):

HSV-1 Sensitivity: 91.0% (142/156)
HSV-1 Specificity: 96.5% (137/142)
HSV-2 Sensitivity: 96.3% (105/109)
HSV-2 Specificity: 97.4% (184/189)

Low Prevalence Population (n = 77):

HSV-1 Sensitivity: 96.4% (27/28)
HSV-1 Specificity: 97.9% (46/47)
HSV-2 Sensitivity: 75.0% (3/4)
HSV-2 Specificity: 100% (71/71)

Cross-reactivity (Percent Positive):

CMV IgG + / HSV-1: 5.0% (1/20)
CMV IgG + / HSV-2: 0.0% (0/27)
VZV IgG + / HSV-1: 3.0% (1/33)
VZV IgG + / HSV-2: 2.9% (1/34)
EBV IgG + / HSV-1: 3.1% (1/32)
EBV IgG + / HSV-2: 3.2% (1/31)

Predicate Device(s)

HerpeSelect 1 and 2 Immunoblot IgG

Reference Device(s)

HerpeSelect2 ELISA IgG

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 866.3305 Herpes simplex virus serological assays.

(a)
Identification. Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.(b)
Classification. Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, sans-serif font, with a curved, swooping graphic element to the left of the word. Below "FOCUS" is the word "Diagnostics" in a smaller, non-bold font, underlined with a thin line. The overall design is simple and professional.

07151

of Safety and Effectiveness

V 1 and 2 IgG (with software) Catalog Number: MP0900G Prepared: September 24, 2007 Page 1 of 8

| Applicant | Focus Diagnostics, Inc.
10703 Progress Way
Cypress, California 90630
USA |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration No. | 2023365 |
| Contact Person | Constance Bridges
Sid Mathur (Alternate Contact)
tel 714.220.1900
fax 714.995.6921
cbridges@focusdx.com
smathur@focusdx.com |
| Summary Date | September 24, 2007 |

OCT 5 2007

Proprietary Name	Plexus™ HerpeSelect® HSV 1 and 2 IgG (with software)
Generic Name	Herpes Simplex Virus Types 1 and 2 Serological Assays
Classification	Class II
Predicate Device	HerpeSelect 1 and 2 Immunoblot IgG

Device Description

The Focus Diagnostics Plexus™ HerpeSelect® HSV 1 and 2 IgG (with software) is a multiplexed immunoassay for qualitatively detecting and differentiating human IgG antibodies to HSV-2. Test principle is identical to the predicate device.

Intended Use

The Focus Diagnostics Plexus™ HerpeSelect® HSV 1 and 2 IgG (with software) is intended for qualitatively detecting the presence or absence of human IgG antibodies to HSV-1 and HSV-2 in human sera. The test is indicated for pregnant women and sexually as an aid for presumptively diagnosing HSV-1 and HSV-2 infection. The predictive value of a positive or negative result depends on the population's prevalence and the pretest likelihood of HSV-1 and HSV-2 infection. The test is not intended for donor screening or for self-testing. The performance of this assay has not been established for use in a pediation, for neonatal screening, for testing of immunocompromised patients, for use by a point of care facility or for use with automated equipment.

Test Principle

The Focus Diagnostics HerpeSelect 1 and 2 Plexus IgG uses an Antigen Bead suspension that contains two distinct HSV antigen bead types that fluoresce at different wavelengths and/or intensities: gG-1 beads and gG-2 beads. The Focus Diagnostics HerpeSelect® 1 and 2 Multiplex IgG is a three step procedure.

Patient sera are diluted, and the diluted sera are incubated with Antibodies are present, l . then the antibodies bind to the corresponding antigen beads.
Phycoerythrin-conjugated goat anti-human IgG, (Conjugate) is added, and the Conjugate binds to the bound 2. HSV antibody (if present), and forms a Conjugate-HSV antibody-antigen bead sandwich.
1. Fluorescence from each distinct HSV antigen bead type is measured against a Cut-off Calibrator.

1

Image /page/1/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, sans-serif font. Above and to the left of the word "FOCUS" is a curved, crescent-shaped graphic. Below the word "FOCUS" is the word "Diagnostics" in a smaller, non-bold font, underlined with a thin line.

K071511 510(k) Summary of Safety and Effectiveness Plexus The HerpeSelect® HSV 1 and 2 IgG (with software) Catalog Number: MP0900G Prepared: September 24, 2007

Page 2 of 8

Performance Characteristics

Studies to Validate Plexus™ HerpeSelect® HSV 1 and 2 IgG (with software)

Testing was done at two external sites and one internal site to confirm that assay results obtained using Plexus Software are identical to results calculated manually using the instrument (Luminex) raw data.

Agreement between Index Calculated with Plexus Software and Index Calculated Manually (n = 600)
Sample Type	n	% Agreement; 95% Confidence Interval
HSV-1 Pos	161/161	100%; 95% CI: 0.977 - 1.00
HSV-1 Eqv	4/4	100%; 95% CI: 0.398 - 1.00
HSV-1 Neg	134/134	100%; 95% CI: 0.973 - 1.00
HSV-1 Invalid	1/1	-
HSV-2 Pos	139/139	100%; 95% CI: 0.974 - 1.00
HSV-2 Eqv	7/7	100%; 95% CI: 0.590 - 1.00
HSV-2 Neg	153/153	100%; 95% CI: 0.976 - 1.00
HSV-1 Invalid	1/1	-

100% of HSV-1 indexes and 100% of HSV-2 indexes calculated using the Plexus software mached the indexes calculated manually.

Summary of Previous Studies for Plexus™ HerpeSelect® HSV 1 and 2 IgG (manual calculation)

| Study | | Plexus
HerpeSelect 1
Results | Plexus
HerpeSelect 2
Results |
|-----------------------------------------------|--------------------------|------------------------------------|------------------------------------|
| Pregnant Women (Indicated population) | Specificity | 96.5% | 94.3% |
| | Sensitivity | 92.2% | 95.5% |
| Sexually Active Adults (Indicated population) | Specificity | 91.0% | 96.3% |
| | Sensitivity | 96.5% | 97.4% |
| CDC HSV/CMV Panel | Agreement with positives | 100% | 100% |
| | Agreement with negatives | 100% | 100% |
| Low Prevalence Population | Agreement with negatives | 97.9% | 100% |
| Cross-reactivity with CMV, EBV and VZV. | Cross-reactivity | 0-5% | 0-3% |
| Reproducibility | %CV of positives | ≤10% | ≤10% |

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Image /page/2/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in large, bold, sans-serif font, with the word "Diagnostics" in a smaller font size underneath. To the left of the word "FOCUS" is a curved, black shape that resembles a stylized check mark or a swoosh.

K071511 510(k) Summary of Safety and Effectiveness

Plexus 131 HerpeSelect® HSV 1 and 2 IgG (with software) Catalog Number: MP0900G Prepared: September 24, 2007 Page 3 of 8

Sensitivity and Specificity with Pregnant Women (n = 300)

Focus (n = 150) and an external investigator (n = 150) assessed the device's reactivity with sera from pregnant women. The sera were sequentially submitted to the laboratory, archived, and masked. The external investigator was a University laboratory located in Northern California, and the sera were collected in the Pacific Northwestern United States. The gold-standard reference method was the Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG for calculation of sensitivity and specificity. The device was also evaluated with the HerpeSelect2 ELISA IgG a cleared predicate device which is not required for regulatory clearance for typing assay.

HSV-1 Sensitivity and Specificity The Focus HerpeSelect 1 Immunoblot IgG was: HSV-1 positive for 170 samples, HSV-1 negative with 128 samples, and HSV Common Antigen band positive for two samples.

The Plexus HerpeSelect 1 agreed with: 96.5% (164/170) of Immunoblot positives, and 92.2% (118/128) of Immunoblot negatives. The two Immunoblot HSV Common Antigen band positives were both negative in the Plexus.

HSV-2 Sensitivity and Specificity The Focus HerpeSelect 2 Immunoblot IgG was: HSV-2 positive for 122 samples, HSV-2 negative with 176 samples, and HSV Common Antigen band positive for two samples.

The Plexus HerpeSelect 2 agreed with: 94.3% (115/122) of Immunoblot positives, and 95.5% (168/176) of Immunoblot negatives. The two Immunoblot HSV Common Antigen band positives were both negative in the Plexus.

| Lab | Herpe-
Select
Immun
oblot | n | Neg | Eqv | Pos | Sensitivity and
Specificity | n | Neg | Eqv | Pos | % Agreement |
|---------------------|------------------------------------|-----|-----|-----|-----|-------------------------------------|-----|-----|-----|-----|-------------------------------------|
| Focus and
Site 1 | Pos | 170 | 6 | 0 | 164 | 96.5% (164/170)
95%CI 92.5-98.7% | 170 | 5 | 1 | 164 | 96.5% (164/170)
95%CI 92.5-98.7% |
| Focus and
Site 1 | Neg | 128 | 118 | 3 | 7 | 92.2% (118/128)
95%CI 86.1-96.2% | 128 | 118 | 3 | 7 | 92.2% (118/128)
95%CI 86.1-96.2% |
| Focus and
Site 1 | Com | 2 | 2 | 0 | 0 | Na | 2 | 2 | 0 | 0 | Na |

Plexus HerpeSelect 1 IgG Reactivity with Expectant Mothers (n = 300)

Plexus HerpeSelect 2 IgG Reactivity with Expectant Mothers (n = 300)

| Lab | Herpe-
Select
Immun
oblot | Plexus HerpeSelect-2 | | | | | HerpeSelect-2 ELISA | | | | |
|---------------------|------------------------------------|----------------------|-----|-----|-----|-------------------------------------|---------------------|-----|-----|-----|----------------------------------------|
| | | n | Neg | Eqv | Pos | Sensitivity and
Specificity | n | Neg | Eqv | Pos | % Agreement |
| Focus and
Site 1 | Pos | 122 | 5 | 2 | 115 | 94.3% (115/122)
95%CI 88.5-97.7% | 122 | 3 | 0 | 119 | 97.5%
(119/122)
95%CI 93.0-99.5% |
| Focus and
Site 1 | Neg | 176 | 168 | 3 | 5 | 95.5% (168/176)
95%CI 91.2-98.0% | 176 | 166 | 1 | 9 | 94.3% (166/176)
95%CI 89.8-97.2% |
| Focus and
Site 1 | Com | 2 | 2 | 0 | 0 | Na | 2 | 2 | 0 | 0 | Na |

3

Image /page/3/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in large, bold, sans-serif font, with the word "Diagnostics" in a smaller font size underneath. A curved, black swoosh is positioned to the left of the word "FOCUS", adding a dynamic element to the design. The overall design is simple, clean, and professional.

07151 510(k) Summary of Safety and Effectiveness Plexus TM HerpeSelect® HSV 1 and 2 IgG (with software) Catalog Number: MP0900G Prepared: September 24, 2007 Page 4 of 8

Reactivity with Sexually Active Adults (n = 300)

Focus (n = 150) and an external investigator (n = 150) assessed the device's reactivity with sera from sexually active adults. The sera were sequentially submitted to the laboratory, archived, and masked. The external investigator was a clinical laboratory located in Southern California, and the sera were collected in the Pacific Northwestern United States. The gold-standard reference method was the Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG for calculation of sensitivity and specificity. The device was also evaluated with the HerpeSelect2 ELISA IgG a cleared predicate device which is not required for regulatory clearance for typing assay.

HSV-1 Sensitivity and Specificity

The Focus HerpeSelect 1 Immunoblot IgG was: HSV-1 positive for 157 samples, HSV-1 negative with 142 samples, and HSV Common Antigen band positive for one sample.

The Plexus HerpeSelect 1 agreed with: 91.0% (142/156) of Immunoblot positives (one sample was not run on the Plexus device), and 96.5% (137/142) of Immunoblot negatives.

HSV-2 Sensitivity and Specificity The Focus HerpeSelect 2 Immunoblot IgG was: HSV-2 positive for 109 samples, HSV-2 negative with 190 samples, and HSV Common Antigen band positive for one sample.

The Plexus HerpeSelect 2 agreed with: 96.3% (105/109) of Immunoblot positives, and 97.4% (184/189) of Immunoblot negatives (one sample was not run on the Plexus device).

Plexus HerpeSelect 1 IgG Reactivity with Sexually Active Adults (n = 300)

| Lab | Herpe-
Select
Immun
oblot | Plexus HerpeSelect-1 | | | | | | HerpeSelect-1 ELISA | | | | |
|---------------------|------------------------------------|----------------------|-----|-----|-----|-------------------------------------|-----|---------------------|-----|-----|-------------------------------------|--|
| | | n | Neg | Eqv | Pos | Sensitivity and
Specificity | n | Neg | Eqv | Pos | % Agreement | |
| Focus and
Site 2 | Pos | 156 | 9 | 5 | 142 | 91.0% (142/156)
95%CI 85.4-95.0% | 157 | 7 | 2 | 147 | 93.6% (147/157)
95%CI 88.6-96.9% | |
| Focus and
Site 2 | Neg | 142 | 137 | 3 | 2 | 96.5% (137/142)
95%CI 92.0-98.9% | 142 | 137 | 1 | 4 | 96.5% (137/142)
95%CI 92.0-98.9% | |
| Focus and
Site 2 | Com | 1 | 1 | 0 | 0 | na | 1 | 1 | 0 | 0 | na | |

*One of 300 samples was not run in the Plexus HerpSelect, and that one sample was HSV-1 negative/HSV-2 positive in the Immunoblot.

Plexus HerpeSelect 2 IgG Reactivity with Sexually Active Adults (n = 300)

| Lab | Herpe-
Select
Immun
oblot | | Plexus HerpeSelect-2 | | | | HerpeSelect-2 ELISA | | | | |
|---------------------|------------------------------------|-----|----------------------|-----|-----|-------------------------------------|---------------------|-----|-----|-----|-------------------------------------|
| | | n | Neg | Eqv | Pos | % Agreement | n | Neg | Eqv | Pos | % Agreement |
| Focus and
Site 2 | Pos | 109 | 3 | 1 | 105 | 96.3% (105/109)
95%CI 90.9-99.0% | 109 | 1 | 1 | 107 | 98.2% (107/109)
95%CI 93.5-99.8% |
| Focus and
Site 2 | Neg | 189 | 184 | 1 | 4 | 97.4% (184/189)
95%CI 93.9-99.1% | 190 | 186 | 1 | 3 | 97.9% (186/190)
95%CI 94.7-99.4% |
| Focus and
Site 2 | Com | 1 | 1 | 0 | 0 | na | 1 | 1 | 0 | 0 | na |

*One of 300 samples was not run in the Plexus HerpeSelect, and that one sample was HSV-1 negative in the Immunible.

4

Image /page/4/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, sans-serif font, with a curved, black shape resembling a swoosh or checkmark to the left of the word. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin black line.

K071511

510(k) Summary of Safety and Effectiveness Plexus The HerpeSelect® HSV 1 and 2 IgG (with software) Catalog Number: MP0900G Prepared: September 24, 2007 Page 5 of 8

Agreement with CDC Panel (n = 100)

The following information is from a serum panel obtained from the CDC and tested by Focus Diagnostics. The results are presented as a means to convey further information on the performance of this assay with a masked, characterized serum panel. This does not imply an endorsement of the assay by the CDC.

The test panel consists of 100 samples. This panel contains duplicate samples of 50 test sera. The duplicates serve to test for reproducibility. There are 16 HSV-1 positive, 11 double-positive and 16 doublenegative sera resulting in 54 HSV-1 positive and 36 HSV-2 positive specimens.

Determination of positive and negative samples

Of the 54 HSV-1 positive samples, the HerpeSelect® Plexus IgG correctly identified 100% (54/54). Of the 36 HSV-2 positive samples, the HerpeSelect® Plexus IgG correctly identified 100% (36/36). Of the 22 double positive samples, the HerpeSelect® Plexus IgG correctly identified 100% (22/22). Of the 32 double negative samples, the HerpeSelect® Plexus IgG correctly identified 100% (32/32).

			HerpeSelect-1 Plexus Results				HerpeSelect-2 Plexus Results
Sample Type	CDC Result		n	Neg	Eqv	Pos	% Agreement	Neg	Eqv	Pos	% Agreement
	HSV1	HSV2
HSV-1
Positive	Pos	Neg	32	0	0	32	100% (32/32)
95%CI 89.1-100%	32	0	0	100% (32/32)
95%CI 89.1-100%
HSV-2
Positive	Neg	Pos	14	14	0	0	100% (14/14)
95%CI 76.8-100%	0	0	14	100% (14/14)
95%CI 76.8-100%
Dual
Positive	Pos	Pos	22	0	0	22	100% (22/22)
95%CI 84.6-100%	0	0	22	100% (22/22)
95%CI 84.6-100%
Dual
Negative	Neg	Neg	32	32	0	0	100% (32/32)
95%CI 89.1-100%	32	0	0	100% (32/32)
95%CI 89.1-100%

Agreement with CDC Panel (n = 100)

CDC Panel Reproducibility

All paired sera were correctly identified: The Focus Diagnostics HerpeSelect® 1 and 2 Plexus IgG identified 16 out of 16 paired HSV-1 positive and HSV-2 negative (100%), 7 out of 7 paired HSV-2 positive and HSV-1 negative (100%), 11 out of 11 paired double-positive (100%) and 16 out of 16 paired double-negative (100%) samples.

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Image /page/5/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of a stylized black swoosh above the word "FOCUS" in bold, sans-serif font. Below "FOCUS" is the word "Diagnostics" in a smaller, non-bold, sans-serif font, underlined with a thin black line. The overall design is simple and professional.

K071511

510(k) Summary of Safety and Effectiveness Plexus 11 HerpeSelect® HSV 1 and 2 IgG (with software) Catalog Number: MP0900G Prepared: September 24, 2007 Page 6 of 8

Specificity with a Low Prevalence Population (n = 77)

Focus (n = 77) assessed the device's reactivity with sera from a low prevalence population. Focus selected sera from patients aged 18 and 19 years, and that had been submitted to a clinical laboratory in Southern California from states having a history of low sexually transmitted disease prevalence. Focus excluded sera that were submitted for sexually transmitted diseases, herpesvirus testing, and tests indicating the patient may be immunocompromised. The sera were sequentially selected, archived and masked. The HerpeSelect Plexus results were compared to the Focus HerpeSelect 1 and 2 Immunoblot IgG.

HSV-1 Reactivity

The Focus HerpeSelect 1 Immunoblot IgG was: HSV-1 positive for 28 samples, HSV-1 negative with 47 samples, and HSV Common Antigen band positive for two samples.

The Plexus HerpeSelect 1 agreed with: 96.4% (27/28) of Immunoblot positives (one HSV-1 Immunoblot positive was equivocal in the Plexus device), and 97.9% (46/47) of Immunoblot negatives (one HSV-1 Immunoblot negative was positive in the Plexus device).

One Immunoblot HSV Common Antigen band positive was equivocal in the Plexus, and the other sample was Plexus negative.

HSV-2 Reactivity

The Focus HerpeSelect 2 Immunoblot IgG was: HSV-2 positive for four samples, HSV-2 negative with 71 samples, and HSV Common Antigen band positive for two samples.

The Plexus HerpeSelect 2 agreed with: 75.0% (3/4) of Immunoblot positives (one HSV-1 Immunoblot positive was equivocal in the Plexus device), and 100% (71/71) of Immunoblot negatives (one HSV-1 Immunoblot negative was positive in the Plexus device). Both Immunoblot HSV Common Antigen band positives were negative in the Plexus.

| HerpeSelect

Immunoblot	Plexus HerpeSelect-1				Plexus HerpeSelect-2
	n	Neg	Eqv	Pos	Sensitivity and
Specificity	n	Neg	Eqv	Pos	Sensitivity and
Specificity
Positive	28	0	1	27	96.4% (27/28)
95%CI 81.6-99.9%	4	0	1	3	75.0% (3/4)
95%CI 19.4-99.4%
Negative	47	46	0	1	97.9% (46/47)
95%CI 88.7-99.9%	71	71	0	0	100% (71/71)
95%CI 94.9-100%
Common	2	1	1	0	NA	2	2	0	0	NA

Specificity with Low Prevalence Population (n = 77)

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Image /page/6/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, sans-serif font, with the word "Diagnostics" in a smaller font size underneath. A curved, black shape is positioned to the left of the word "FOCUS", resembling a stylized check mark or a swoosh. The overall design is simple and professional, suggesting a focus on precision and accuracy in diagnostics.

0715

510(k) Summary of Safety and Effectiveness

Plexus HerpeSelect® HSV 1 and 2 IgG (with software) Catalog Number: MP0900G Prepared: September 24, 2007 Page 7 of 8

Cross-reactivity (n = 51)

Focus assessed cross-reactivity with two groups of samples: a "HSV ELISA dual negative" group (n=37), and a "HSV ELISA mixed sero-reactivity" group (n=14).

The HSV ELISA dual negative group (n=37) included samples that were sero-negative with both the HerpeSelect-1 ELISA IgG and HerpeSelect 2 ELISA IgG, and were sero-positive by at least one of

a FDA cleared CMV ELISA IgG (n = 18),

a home brerw VZV ACIF (n=32),

a FDA cleared EBV VCA IgG (n=31).

The HerpeSelect 1 and 2 Plexus IgG was HSV-1 negative with all but one of the HSV ELISA dual negatives, and equivocal with one sample (the one sample was CMV+ VZV+ and EBV+).

The HerpeSelect 1 and 2 Plexus IgG was HSV-2 negative with all but one of the HSV ELISA dual negatives, and equivocal with one sample (the one sample was CMV- VZV+ and EBV+).

The HSV ELISA mixed reactivity group (n=14) included samples that were sero-positive with either the HerpeSelect-1 ELISA IgG or HerpeSelect 2 ELISA IgG, and were sero-positive by at least one of

a FDA cleared CMV ELISA IgG (HSV-1 neg n = 2, HSV-2 neg n = 9),

a home brew VZV ACIF (HSV-1 neg n = 1, HSV-2 neg n = 2),

a FDA cleared EBV VCA IgG (HSV-1 neg n = 1, HSV-2 neg n = 0).

The HerpeSelect 1 and 2 Plexus IgG was HSV-1 negative with all of the HSV-1 ELISA negatives in the mixed reactivity group.

The HerpeSelect 1 and 2 Plexus IgG was HSV-2 negative with all of the HSV-2 ELISA negatives in the mixed reactivity group.

Cross-reactivity (n = 51)
Cross-reactant	HSV
ELISAs	n	Neg	Eqv*	Pos	%Pos	n	Neg	Eqv†	Pos	%Pos
CMV IgG +	Dual Neg	18	17	1	0	5.6% (1/18)
95%CI 0.1-27.3%	18	18	0	0	0.0% (0/18)
95%CI 0.0-18.5%
	+/- or -/+	2	2	0	0	0.0% (0/2)
95%CI 0.0-84.2%	9	9	0	0	0.0% (0/9)
95%CI 0.0-33.6%
	Total	20	19	1	0	5.0% (1/20)
95%CI 0.1-24.9%	27	27	0	0	0.0% (0/27)
95%CI 0.0-12.8%
VZV IgG +	Dual Neg	32	31	1	0	3.1% (1/32)
95%CI 0.1-16.2%	32	31	1	0	3.1% (1/32)
95%CI 0.1-16.2%
	+/- or -/+	1	1	0	0	0.0% (0/1)
NA	2	2	0	0	0.0% (0/2)
95%CI 0.0-84.2%
	Total	33	32	1	0	3.0% (1/33)
95%CI 0.1-15.8%	34	33	1	0	2.9% (1/34)
95%CI 0.1-15.3%
EBV IgG +	Dual Neg	31	30	1	0	3.2% (1/31)
95%CI 0.1-16.7%	31	30	1	0	3.2% (1/31)
95%CI 0.1-16.7%
	+/- or -/+	1	1	0	0	0.0% (0/1)
NA	0	0	0	0	NA
	Total	32	31	1	0	3.1% (1/32)
95%CI 0.1-16.2%	31	30	1	0	3.2% (1/31)
95%CI 0.1-16.7%

The HerpeSelect-1 Plexus was equivocal with one sample, and the sample was IgG positive for CMV, VZV and EBV.

The HerpeSelect -2 Plexus was equivocal with one sample was IgG positive for VZV and EBV.

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Image /page/7/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, sans-serif font, with a curved, swooping graphic element to the left of the word. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin line.

10(k) Summary of Safety and Effectiveness TM HerpeSelect® HSV 1 and 2 IgG (with software) Catalog Number: MP0900G Prepared: September 24, 2007

Page 8 of 8

Inter-laboratory Reproducibility and Inter/Intra-assay Reproducibility

Focus, a clinical laboratory located in Southern California, and a university laboratory located in Northern California assessed the device's inter-laboratory reproducibility and inter/intra-assay reproducibility. Each of the three laboratories tested eleven samples in triplicate on five different days.

Inter-laboratory Reproducibility and Inter/Intra-assay Reproducibility"
HerpeSelect 1 Plexus IgG Results			HerpeSelect 2 Plexus IgG Results
Intra- and Inter-assay			Inter-Lab	Intra- and Inter-assay		Inter-Lab
Sample	Mean Index	Intra-assay % CV	Inter-assay % CV	Mean Index	% CV	Mean Index	Intra-assay % CV	Inter-assay % CV	Mean Index	% CV
9	4.93	3.6	10.3	4.94	3.7	3.88	3.4	10.0	3.87	2.5
6	4.24	3.8	8.7	4.22	3.3	4.90	2.6	8.5	4.89	2.1
2	3.87	4.8	7.9	3.86	1.3	3.36	4.3	7.7	3.35	2.0
8	3.27	4.9	9.1	3.25	3.0	4.56	3.1	8.3	4.55	1.5
4	3.24	4.9	7.4	3.22	2.1	2.55	4.5	8.9	2.54	5.8
1	3.04	4.3	8.9	3.02	2.3	2.71	3.8	9.3	2.70	2.1
12b	2.13	7.9	8.7	2.13	4.1	1.87	7.2	8.8	1.87	3.4
3	0.34	9.1	14.9	0.34	6.8	0.06	8.7	28.3	0.06	22.6
10c	0.19	9.9	213.1	0.19	59.0	0.12	11.4	334.2	0.40	103.8
10d	0.13	10.0	15.8	0.12	1.9	0.06	11.5	41.7	0.06	38.3
7	0.18	8.3	16.3	0.17	9.4	0.06	8.1	23.7	0.06	17.3
5	0.14	9.0	16.0	0.14	2.7	0.06	8.3	39.8	0.06	38.1

Inter-laboratory Reproducibility and Inter/Intra-assay Reproducibility"

a. Excludes two runs at one site that were invalide Control index was beyond the accoptable QC criteria (it appears that the Positive Control was run in those wells since the indices were about 1.9 for both gG1 and gG2)

b. Samples 12 (inter-lab reproducibility) and 14 (inter-lot reproducibility below) were scparate samples with the same sera Samples 11 did not have sufficient volume to be sent to investigators.

c. This line includes all data for Sample 10, including one run at Lab 2, where it appears that Sample 1 may have the indices were about 2.7 for both gG1 and gG2.

d. This line includes all data for Sample 10, except for one at Lab 2, where it appears that Sample 1 may have been run instead since the indices were about 2.7 for both gG1 and gG2.

Inter-Lot Reproducibility

Focus assessed the device's Inter-lot Reproducibility by testing eleven samples with three separate lots. The samples were run in triplicate. Each lot had a different set of gG-1 and gG2 beads, a different lot of conjugate (made from 2 different stock conjugates), and a different lot of calibrator (made from 2 different combinations of positive and negative sera). The results of the studies are summarized in the tables below:

Inter-lot Reproducibility
Sample	HSV-1		HSV-2
	Mean Index	Inter-Lot %CV	Mean Index	Inter-Lot %CV
9	5.20	7.4	3.90	12.8
6	4.36	8.5	4.76	9.2
2	3.60	7.3	3.19	9.3
4	3.29	7.9	2.54	6.4
8	3.23	11.3	4.45	9.4
1	3.14	5.8	2.73	4.8
12/14*	2.22	10.5	1.86	7.8
3	0.31	17.0	0.11	50.9
7	0.15	31.3	0.08	21.8
5	0.10	45.6	0.06	24.9
10	0.09	50.6	0.06	26.9

Inter-lot Reproducibility

Samples 12 (inter-lab reproducibility above) and 14 (inter-lot reproducibility) were scparate samples, but the same sera. Samples 11 and 13 did not have sufficient volume to be sent to investigators.

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Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Constance Bridges, MBA, RAC, ASQ-CBA Director, Regulatory and Compliance Focus Diagnostics, Inc. 10703 Progress Way Cypress, California 90630

0CT 5 " 2007

Re: K071511

Trade/Device Name: Plexus™ HerpeSelect® HSV 1 and 2 IgG (with software) Regulation Number: 21CFR 866.3305 Regulation Name: Herpes simplex virus serological reagents Regulatory Class: Class II Product Code: MXJ, MYF Dated: September 5, 2007 Received: September 10, 2007

Dear Ms. Bridges:

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.

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 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 Part 801); 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.

9

Page 2 - Michael J. Wagner

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 Compliance at (240) 276- 0100. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sayar

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

Enclosure

10

510(k) Number (if known):

K071511

Device Name:

Indications for Use:

Plexus™ HerpeSelect® HSV 1 and 2 IgG (with software)

The Focus Diagnostics Plexus™ HerpeSelect® HSV 1 and 2 IgG (with software) is intended for qualitatively detecting the presence or absence of human IgG antibodies to HSV-1 and HSV-2 in human sera. The test is indicated for pregnant women and sexually active adults, as an aid for presumptively diagnosing HSV-1 and HSV-2 infection. The predictive value of a positive or negative result depends on the population's prevalence and the pretest likelihood of HSV-1 and HSV-2 infection. The test is not intended for donor screening or for self-testing. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, for testing of immunocompromised patients, for use by a point of care facility or for use with automated equipment.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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