Predicate Devices

Diamedix EBV VCA IgG ELISA, Diamedix EBV EBNA-1 IgG ELISA, Diamedix EBV EA-D IgG ELISA, ATHENA MULTI-LYTE EBV IGG TEST SYSTEM, Focus EBV-VCA ANTIBODY (IGG) - IFA

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on a multiplexed immunoassay using antigen beads and fluorescence measurement, which are standard laboratory techniques and do not indicate the use of AI/ML. There are no mentions of AI, DNN, or ML in the provided text.

Therapeutic

No
The device is a diagnostic test kit for detecting antibodies to the Epstein-Barr virus, aiding in the diagnosis of EBV infection and infectious mononucleosis. It does not treat or prevent disease.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the test kit is "intended for qualitatively detecting the presence or absence of human IgG class antibodies to viral capsid antigen (VCA), early antigen- diffuse (EA-D), and nuclear antigen (EBNA-1) of Epstein-Barr virus in human sera" and is "indicated as an aid in the diagnosis of EBV infection and EBV-associated infectious mononucleosis." This directly indicates its use for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device is a multiplexed immunoassay kit that uses antigen beads and fluorescence measurements to detect antibodies in human sera. This involves physical reagents and laboratory procedures, not solely software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use explicitly states it's for "qualitatively detecting the presence or absence of human IgG class antibodies... in human sera." This involves testing a sample taken from the human body in vitro (outside the body) to gain information about a person's health status (EBV infection).
Indications for Use: It's indicated as "an aid in the diagnosis of EBV infection and EBV-associated infectious mononucleosis." This directly relates to providing diagnostic information.
Device Description: The description details a "Multiplexed Immunoassay" that uses "human sera" and involves steps like incubating with "Patient sera" and measuring "Fluorescence from each distinct EBV antigen bead type." This is a typical description of an in vitro diagnostic test.
Performance Studies: The document describes studies comparing the device's performance against "commercially available ELISA assays" and other "FDA-cleared commercially available" tests, which are common comparisons for IVDs seeking regulatory clearance.

All these points align with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Focus Diagnostics' Plexus™ EBV IgG Multi-Analyte Diagnostics test kit is intended for qualitatively detecting the presence or absence of human IgG class antibodies to viral capsid antigen (VCA), early antigen- diffuse (EA-D), and nuclear antigen (EBNA-1) of Epstein-Barr virus in human sera. The test is indicated as an aid in the diagnosis of EBV infection and EBV-associated infectious mononucleosis.

The performance of this assay has not been established for use in the diagnosis of nasopharyngeal carcinoma and Burkit's lymphoma, for testing of immunocompromised patients, for use by a point of care facility or for use with automated equipment. This assay has not been evaluated for donor screening.

Product codes

LSE

Device Description

Multiplexed Immunoassay for the Qualitative Detection of Human IgG Antibodies to Epstein-Barr Virus

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

Not Found

Intended User / Care Setting

Not Found

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

Samples were collected at three sites and include both prospective (n = 723) and retrospective (n = 150) specimens. Retrospective samples were pre-selected based on EBV VCA Inc reas ons of the for ma FDA cleared device. The study was conducted at Plain Maria Ma United States testing sites: a hospital laboratory located in Northeast, a pediatic hospital laboratory located in the Mid-West, and Focus. The sera were sequentially submitted to the laboratory, and masked.

For EBV VCA IgG vs Consensus Predicate, the consensus predicate was a combination of a FDA-cleared commercially available ELISA, a FDA cleared commercially available immunofluorescent (JPA) est and a FDA cleared commercially available flow cytometry based immunoassay. For EBNA-1 IgG and EA-D IgG, a commercially available ELISA test was used as the predicate.

Summary of Performance Studies

Inter-laboratory, Intra-assay and Inter-assay Reproducibility:
Three laboratories tested twelve samples in triplicate on five different days. The mean index and %CV (intra-assay, inter-assay, inter-lab) are provided for various samples for Plexus VCA IgG, Plexus EBNA IgG, and Plexus EA IgG.

Inter-Lot Reproducibility:
Fifteen samples were evaluated across three lots of Plexus EBV kit. The mean and %CV are provided for each sample across Plexus VCA IgG, Plexus EBNA IgG, and Plexus EA-D IgG.

Cross-Reactivity:
A panel of samples (ANA=28, CMV=31, HSV-2=13, HSV-6=4, Rubeola Virus=1, Rubella Virus=39, Toxoplasma gondii=19, and VZA=35) were tested. For each cross-reactant, results (Positive, Equivocal, Negative) for Plexus and a comparator ELISA are presented for EBV VCA IgG, EBV EBNA IgG, and EBV EA-D IgG, along with discrepant results. The majority of positive results were confirmed by ELISA, indicating reactivity to EBV IgG antibodies rather than cross-reactivity.

Sample Storage and Handling:
Fifteen negative and positive EBV IgG samples were subjected to up to five freeze-thaw cycles. No effect was observed.

Interference:
Four samples (two positive for EBV IgG, two negative) were tested with spiked levels of triglycerides, albumin, bilirubin, and hemoglobin. No interference was observed.

Key Metrics

EBV VCA IgG vs Consensus Predicate (Prospective Population Samples N = 723):

Acute / Primary Acute: Positive Agreement: 100% (57/57); Negative Agreement: 33.3% (1/3)
Acute / Late Acute: Positive Agreement: 97.2% (70/72)
Recovering: Positive Agreement: 100% (1/1)
Previous Infection: Positive Agreement: 96.6% (282/292); Negative Agreement: 83.3% (5/6)
No Infection: Positive Agreement: 30% (3/10); Negative Agreement: 93.5% (203/217)
Indeterminate: Positive Agreement: 98% (49/50); Negative Agreement: 100% (15/15)

EBV EBNA-1 vs Predicate (Prospective Population Samples N = 723):

Primary Acute: Negative Agreement: 100% (60/60)
Late Acute: Positive Agreement: 94.2% (65/69); Negative Agreement: 100% (3/3)
Recovering: Negative Agreement: 100% (1/1)
Previous Infection: Positive Agreement: 93.7% (266/284); Negative Agreement: 92.9% (13/14)
No Infection: Negative Agreement: 99.6% (226/227)
Indeterminate: Positive Agreement: 76.3% (29/38); Negative Agreement: 100% (27/27)

EBV EA-D vs Predicate (Prospective Population Samples N = 723):

Acute / Primary Acute: Positive Agreement: 93% (40/43); Negative Agreement: 76.5% (13/17)
Acute / Late Acute: Positive Agreement: 80.4% (41/51); Negative Agreement: 81% (17/21)
Recovering: Positive Agreement: 0% (0/1)
Previous Infection: Negative Agreement: 96% (286/298)
No Infection: Negative Agreement: 98.2% (223/227)
Indeterminate: Positive Agreement: 26.9% (7/26); Equivocal Agreement: 6.3% (2/32); Negative Agreement: 62.2% (23/37)

EBV VCA IgG vs Consensus Predicate (Retrospective Presumed Acute Population Samples N = 150):

Acute: Positive Agreement: 93.4% (99/106)
Acute (Late): Positive Agreement: 100% (8/8)
No Infection: Positive Agreement: 100% (1/1); Negative Agreement: 0% (0/1)
Indeterminate: Positive Agreement: 93.9% (31/33)

EBV EBNA-1 vs Predicate (Retrospective Presumed Acute Population Samples N = 150):

Primary Acute: Negative Agreement: 99.1% (105/106)
Late Acute: Positive Agreement: 0% (0/4); Negative Agreement: 100% (4/4)
No Infection: Negative Agreement: 100% (2/2)
Indeterminate: Positive Agreement: 0% (0/8); Equivocal Agreement: 0% (0/4); Negative Agreement: 100% (26/26)

EBV EA-D vs Predicate (Retrospective Presumed Acute Population Samples N = 150):

Primary Acute: Positive Agreement: 93.4% (57/61); Negative Agreement: 77.8% (35/45)
Late Acute: Positive Agreement: 100% (3/3); Negative Agreement: 80% (4/5)
No Infection: Negative Agreement: 100% (2/2)
Indeterminate: Positive Agreement: 66.7% (8/12); Equivocal Agreement: 0% (0/14); Negative Agreement: 40.9% (9/22)

Predicate Device(s)

Diamedix EBV VCA IgG ELISA, Diamedix EBV EBNA-1 IgG ELISA, Diamedix EBV EA-D IgG ELISA, ATHENA MULTI-LYTE EBV IGG TEST SYSTEM, Focus EBV-VCA ANTIBODY (IGG) - IFA

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 866.3235 Epstein-Barr virus serological reagents.

(a)
Identification. Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).(b)
Classification. Class I (general controls).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in bold, sans-serif font, with the word "Diagnostics" in a smaller, non-bold font underneath. A curved, black shape is to the left of the word "FOCUS", and a line is underneath the word "FOCUS" and above the word "Diagnostics".

510(k) Summary of Safety and Effectiveness Plexus EBV IgG Multi-Analyte Diagnostics Catalog No. MP0500G Prepared Date: July 17, 2008

073382

Page 1 of 17

| Applicant | Focus Diagnostics, Inc.
10703 Progress Way
Cypress, California 90630
USA |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration No. | 2023365 |
| Contact Person | Constance Bridges
tel 714.220.1900
fax 714.995.6921
cbridges@focusdx.com |
| Summary Date | July 17, 2008 |
| Proprietary Name | Plexus EBV IgG Multi-Analyte Diagnostics |
| Generic Name | Epstein-Barr Virus Serological Assays |
| Classification | Class I |
| Predicate Devices | Diamedix EBV VCA IgG ELISA
Diamedix EBV EBNA-1 IgG ELISA
Diamedix EBV EA-D IgG ELISA
ATHENA MULTI-LYTE EBV IGG TEST SYSTEM
Focus EBV-VCA ANTIBODY (IGG) - IFA |

JUL 2 8 2008#### Device Description

Multiplexed Immunoassay for the Qualitative Detection of Human IgG Antibodies to Epstein-Barr Virus

Intended Use

Focus Diagnostics' Plexus™ EBV IgG Multi-Analyte Diagnostics test kit is intended for qualitatively detecting the presence or absence of human IgG class antibodies to viral capsid antigen (VCA), early antigen- diffuse (EA-D), and nuclear antigen (EBNA-1) of Epstein-Barr virus in human sera. The test is indicated as an aid in the diagnosis of EBV infection and EBV-associated infectious mononucleosis.

The performance of this assay has not been established for use in the diagnosis of nasopharyngeal carcinoma and Burkit's lymphoma, for testing of immunocompromised patients, for use by a point of care facility or for use with automated equipment. This assay has not been evaluated for donor screening.

Test Principle

The Focus Diagnostics Plexus™ EBV IgG uses an Antigen Bead suspension that contains three distinct EBV antigen bead types (EA-D, VCA, & EBNA-1) and one process control bead type that fluoresce at different wavelengths and/or intensities.

The Focus Diagnostics Plexus™ EBV IgG is a three step procedure,

Patient sera are diluted, and the diluted sera are incubated with Antigen Beads. If EBV antibodies are present, 1. then the antibodies bind to the corresponding antigen beads.
1. Phycoerythrin-conjugated goat Anti-human IgG (Conjugate) is added, binds to the bound EBV antibody (if present), and forms a Conjugate-EBV antibody-antigen bead sandwich.
1. Fluorescence from each distinct EBV antigen bead type is measured and compared against a Cutoff Calibrator.

1

Image /page/1/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, sans-serif font underneath and a horizontal line separating the two words. To the left of the word "FOCUS" is a stylized, curved shape that resembles a swoosh or a checkmark.

510(k) Summary of Safety and Effectiveness Plexus EBV IgG Multi-Analyte Diagnostics Catalog No. MP0500G Prepared Date: July 17, 2008 Page 2 of 17

Comparison of Plexus EBV VCA IgG analyte to Predicates:

Item	Device		Predicates
Name	Plexus™ EBV IgG
Multi-Analyte
Diagnostics	Diamedix VCA IgG,
ELISA	Athena Multi-Lyte
EBV VCA IgG Test
System	Focus Epstein-Barr
Virus VCA IFA IgG
	Similarities between Device and Predicate
Intended use	Focus Diagnostics'
Plexus™ EBV (VCA)
IgG Multi-Analyte is
intended for
qualitatively detecting
the presence or
absence of human IgG
class antibodies to
viral capsid antigen
(VCA), early antigen
– diffuse pattern (EA-
D), and nuclear
antigen (EBNA-1) of
Epstein-Barr virus
(EBV) in human sera.
The test is indicated
as an aid in the
diagnosis of EBV
infection and EBV-
associated infectious
mononucleosis.	Diamedix Corp EBV
VCA IgG ELISA is
intended for the
qualitative and semi-
quantitative
determination of IgG
antibodies to Epstein-
Barr Virus
(recombinant) Viral
Capsid Antigen (EBV-
VCA IgG) in human
serum by indirect
enzyme immunoassay.
The Is-EBV-VCA IgG
test kit may be used in
combination with other
Epstein-Barr
serologies, Viral Capsid
Antigen (VCA) IgM,
Epstein-Barr Nuclear
Antigen-1 (EBNA-1)
IgG and IgM, Early
Antigen-Diffuse (EA-
D) IgG and IgM and
heterophile antibody, as
an aid in the diagnosis
of infectious
mononucleosis (IM).	The Zeus Scientific,
Inc. AtheNA Multi-
Lyte® EBV IgG
Test System is
intended for the
qualitative
detection of IgG
class antibody to
three separate EBV
Antigens (EBV-
VCA gp-125, EBV-
EA "total" and
recombinant
EBNA-1) in human
serum using the
AtheNA Multi-
Lyte® System. The
test system is
intended to be used
as
an aid in the
laboratory
diagnosis of EBV-
associated
infectious
mononucleosis and
to
provide
epidemiological
information on the
disease caused by
Epstein-Barr virus.	Focus Diagnostics'
Epstein-Barr Virus
Viral Capsid
Antigens (EBV
VCA)
IgG
Immunofluorescence
Antibody (IFA) test
is intended for the
detection and
semi-quantitation of
human IgG
antibodies to the
viral capsid antigens
(VCA)
of Epstein-Barr virus
in human serum as
an aid in the clinical
diagnosis of
infectious
mononucleosis.
Indications for use	The test is indicated
as an aid in the
diagnosis of EBV
infection and EBV-
associated infectious
mononucleosis.	The device is indicated
for use with patients
with the signs and
symptoms of infectious
mononucleosis.	The Zeus
Scientific, Inc.
AtheNA Multi-
Lyte EBV IgG
Test System
is intended for the
qualitative
detection of IgG
class antibody to
three separate
EBV
Antigens (EBV	The test is indicated
as an aid in the
clinical diagnosis of
infectious
mononucleosis.
Item	Device	Predicates
Name	Plexus™ EBV IgG
Multi-Analyte
Diagnostics	Diamedix VCA IgG,
ELISA	Athena Multi-Lyte
EBV VCA IgG Test
System	Focus Epstein-Barr
Virus VCA IFA IgG
			VCA, EBV-EA
and EBNA-1) in
human serum
using the AtheNA
Multi-
Lyte System. The
test system is
intended to be
used with these
EBV IgG markers
along
with anti-EBV
VCA IgM to aid
in the laboratory
diagnosis of
EBV-associated
infectious
mononucleosis
and to provide
epidemiological
information on
the diseases
caused by
EBV virus.
Immunoglobulin
Type	IgG	IgG	IgG	IgG
Sample matrix	Serum	Serum	Serum	Serum
CLIA complexity	High	High	High	High
	Difference between Device and Predicate
Antigen	EBV-VCA: VCA gp
125, affinity purified
antigen	EBV-VCA:
Recombinant 47 kDa
fusion half of p18	EBV VCA gp25
Strain	N/A- purified protein	N/A- Recombinant
protein	N/A native protein	N/A- purified
protein
Host Cell Line	EBV-VCA: Native
(P3H3 or
P3HR-1)	EBV-VCA: E. coli
(unknown)	Unknown
Methodology	Multiplex Microbead
Immunoassay
(MMIA) based on
Luminex XMAP
technology.	Enzyme Immunoassay
technology.	Multiplex bead
immunoassay	Immunofluorescence
Antibody (IFA) test
Item	Device	Predicates
Name	Plexus™ EBV IgG
Multi-Analyte
Diagnostics	Diamedix VCA IgG,
ELISA	Athena Multi-Lyte
EBV VCA IgG Test
System	Focus Epstein-Barr
Virus VCA IFA IgG
Interpretation of
test results	Perform automated
calculations using
Plexus software.	Manual calculation	AtheNA Multi-Lyte
instrument	Manual

2

Image /page/2/Picture/0 description: The image shows the logo for Focus Diagnostics. The word "FOCUS" is in large, bold, sans-serif font. Above the word "FOCUS" is a curved, black shape that resembles a swoosh or checkmark. Below the word "FOCUS" is the word "Diagnostics" in a smaller font, underlined with a thin black line.

510(k) Summary of Safety and Effectiveness Plexus EBV IgG Multi-Analyte Diagnostics Catalog No. MP0500G Prepared Date: July 17, 2008 and the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contributi

Page 3 of 17

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Image /page/3/Picture/0 description: The image shows the logo for Focus Diagnostics. The word "FOCUS" is in large, bold, sans-serif font. A curved line extends from the top left of the image, arcing over the word "FOCUS". Below the word "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin line.

510(k) Summary of Safety and Effectiveness Plexus EBV IgG Multi-Analyte Diagnostics Catalog No. MP0500G Prepared Date: July 17, 2008

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Comparison of Plexus EBV EBNA-1 IgG analyte to Predicate:

Item	Device	Predicate
Name	Plexus™ EBV IgG Multi-Analyte
Diagnostics	Diamedix EBNA-1 IgG ELISA
Similarity between Device and Predicate
Intended use	Focus Diagnostics' Plexus™ EBV (EBNA-

IgG Multi-Analyte is intended for
qualitatively detecting the presence or
absence of human IgG class antibodies to
viral capsid antigen (VCA), early antigen -
diffuse pattern (EA-D), and nuclear antigen
(EBNA-1) of Epstein-Barr virus (EBV) in
human sera. The test is indicated as an aid
in the diagnosis of EBV infection and EBV-
associated infectious mononucleosis. | Diamedix Corp EBV EBNA-1 IgG ELISA
is intended the qualitative and semi-
quantitative determination of IgG antibodies
to Epstein-Barr
Virus (recombinant)
Nuclear Antigen-1 (EBNA-1 IgG) in human
serum by indirect enzyme immunoassay.
The Is-EBNA-1 IgG test kit may be used in
combination with other Epstein-Barr
serologies, viral capsid antigen (VCA) IgG
and IgM, Epstein-Barr nuclear antigen-1
(EBNA-1) IgM, early antigen-diffuse (EA-
D) IgG and IgM and heterophile antibody,
as an aid in the diagnosis of infectious
mononucleosis (IM). |
| Indications for use | The test is indicated as an aid in the
diagnosis of EBV infection and EBV-
associated infectious mononucleosis. | The device is indicated for use with patients
with the signs and symptoms of infectious
mononucleosis. |
| Immunoglobulin Type | IgG | IgG |
| Sample matrix | Serum | Serum |
| CLIA complexity | High | High |
| Difference between Device and Predicate | | |
| Strain | N/A- Recombinant protein | N/A- Recombinant protein |
| Antigen | EBV-EBNA: Recombinant EBNA-1,
truncated, 35 kDa | EBV-EBNA-1: 27 kDa protein purified
native protein (Recombinant protein) |
| Host Cell Line | EBV-EBNA: Pichia pastoris | EBV-EBNA: Native (unknown) |

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Image /page/4/Picture/0 description: The image shows the logo for Focus Diagnostics. The word "FOCUS" is in large, bold, sans-serif font. Above and to the left of the word "FOCUS" is a black, curved shape that resembles a check mark. Below the word "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font with a line above it.

510(k) Summary of Safety and Effectiveness Plexus EBV IgG Multi-Analyte Diagnostics Catalog No. MP0500G Prepared Date: July 17, 2008 Page 5 of 17

Item	Device	Predicate
Name	Plexus™ EBV IgG Multi-Analyte
Diagnostics	Diamedix EBNA-1 IgG ELISA
Methodology	Multiplex Microbead Immunoassay
(MMIA) based on Luminex XMAP
technology.	Enzyme Immunoassay technology.
Interpretation of test
results	Perform automated calculations using	Manual calculation

Comparison of Plexus EBV EA-D IgG analyte to Predicate:

Comparison to Predicate

Item	Device	Predicate
Name	Plexus™ EBV IgG Multi-Analyte
Diagnostics	Diamedix EA-D IgG ELISA
Similarity between Device and Predicate
Intended use	Focus Diagnostics' Plexus™ EBV (EA-D)
IgG Multi-Analyte is intended for
qualitatively detecting the presence or
absence of human IgG class antibodies to
viral capsid antigen (VCA), early antigen –
diffuse pattern (EA-D), and nuclear antigen
(EBNA-1) of Epstein-Barr virus (EBV) in
human sera. The test is indicated as an aid in
the diagnosis of EBV infection and EBV-
associated infectious mononucleosis.	Diamedix Corp.EBV EA-D IgG ELISA is
intended for the qualitative and semi-
quantitative determination of IgG antibodies
to Epstein-Barr Virus (recombinant) Early
Antigen Diffuse (EBV-EA-D IgG) in human
serum by indirect enzyme immunoassay. The
Is-EBV-EA-D IgG test kit may be used in
combination with other Epstein-Barr
serologies, Viral Capsid Antigen (VCA) IgG
and IgM, Epstein-Barr Nuclear Antigen-1
(EBNA-1) IgG and IgM, Early Antigen-
Diffuse (EA-D) IgM and heterophile
antibody, as an aid in the diagnosis of
infectious mononucleosis (IM).
Indications for use	The test is indicated as an aid in the diagnosis
of EBV infection and EBV-associated
infectious mononucleosis.	The device is indicated for use with patients
with the signs and symptoms of infectious
mononucleosis.
Immunoglobulin
Type	IgG	IgG
Sample matrix	Serum	Serum
CLIA complexity	High	High
Difference between Device and Predicate
Antigen	EBV-EA: Recombinant EA-D	EBV-EA: Recombinant EA-D 28 kDa

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Image /page/5/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in bold, sans-serif font, with the word "Diagnostics" in a smaller font size underneath. A curved, black shape is placed to the left of the word "FOCUS", adding a visual element to the logo.

510(k) Summary of Safety and Effectiveness Plexus EBV IgG Multi-Analyte Diagnostics Catalog No. MP0500G Prepared Date: July 17, 2008

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Comparison to Predicate

Item	Device	Predicate
Name	Plexus™ EBV IgG Multi-Analyte
Diagnostics	Diamedix EA-D IgG ELISA
Host Cell Line	EBV-EA: E. coli	EBV-EA: E. coli (unknown)
Strain	N/A- Recombinant protein	N/A- Recombinant protein
Methodology	Multiplex Microbead Immunoassay (MMIA)
based on Luminex XMAP technology.	Enzyme Immunoassay technology.
Interpretation of
test results	Perform automated calculations using Plexus
software.	Manual calculation

EXPECTED VALUES

Outside investigators assessed the device with prospective masked sequential samples that were submitted for routine EBV testing esmants occasion ocean will vary depending on age, geographic location, testing method used and other factors. The comparator assay was performed by indirect enzyme immunoassay used in combination with other Epstein-Barr serologies (VCA) lgG and IgM, Epstein-Barr Nuclear Antigen-1 (EBNA-1) IgG, Early Antigen-Diffuse (EA-D) IgG and a helerophile rooid andiody test, The observed prevalence is in Table 1. The expected values are presented by age and gender in Tables 2-4. For all analytes, index values of 1.10 are positives.

Table 1: Observed Prevalence - EBV Plexus
	VCA IgG	EBNA-1 IgG	EA-D IgG
Positive	66% (478/723)	50% (362/723)	17% (120/723)
Equivocal	0% (3/723)	0% (2/723)	1% (9/723)
Negative	25% (242/723)	50% (349/723)	82% (594/723)

Age	Gender	Positive		Equivocal		Negative
		n	%	n	%	n	%
70	F	7	100	0	0.0	0	0.0
>70	M	7	77.8	1	11.1	1	11.1
Total		478	66.1	3	0.4	242	33.5

Table 3: EBV Plexus Results EBNA-1 IgG
Age	Gender	n	Positive		Equivocal		Negative		Total
			n	%	n	%	n	%
70	F	6	85.7	0	0	0.0	1	14.3	7
>70	M	7	77.8	1	1	11.1	1	11.1	9
Total		362	50.1	2	2	0.3	359	49.7	723

7

Image /page/7/Picture/0 description: The image shows the logo for Focus Diagnostics. The word "FOCUS" is in large, bold, black letters. Above and to the left of the word is a curved black shape. Below the word "FOCUS" is the word "Diagnostics" in smaller, black letters with a line above it.

510(k) Summary of Safety and Effectiveness Plexus EBV IgG Multi-Analyte Diagnostics Catalog No. MP0500G Prepared Date: July 17, 2008

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Table 4: EBV Plexus Results EA-D IgG
			Positive		Equivocal	Negative
Age	Gender	n	%	n	%	n	%	Total
70	F	3	42.9	0	0.0	4	57.1	7
>70	M	0	0.0	0	0.0	9	100.0	9
Total		120	16.6%	9	1.2%	594	82.2%	723

The table below summarizes the breakdown of the samples age and gender information. The distribution chart below exhibits the age distribution of all 873 samples included in the study.

Age Information:
Summary of Female
Subjects	Summary of Male
Subjects
n	474	n	399
mean	20.0	mean	18.3
median	16.0	median	14.0
min	1	min	1
max	88	max	87

8

Image /page/8/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 eye or lens.

510(k) Summary of Safety and Effectiveness Plexus EBV IgG Multi-Analyte Diagnostics Catalog No. MP0500G Prepared Date: July 17, 2008 Page 9 of 17

Distribution of Patient Age 300 250 200 requency 150 100 ടറ 0

PERFORMANCE CHARACTERISTICS

Typical Antibody Response Classification

The table below summarizes a generally accepted algorithm for classifying the EBV infection status via EBV serologic profiles. For acute EBV serological status, booked agointin of blassilynig the LDV incodes to viral capsidade . FBV VCA (gM antibody disappear over approximalely four wiels. Hele capson aligging (very) hise rapuly. EBV vCH (gM fades rapidly over approximally four weeks . EBV EA-D JGG antibody shows a translent raise during acute infections and i undetectable after thee to six months. EDV EBVA-1 lgG antibody usually appears three months after intial infection and temains for life. The serological status was detemined by the use of commercially available in the milial medial. And relialis IgG. VCA JoS States was association of the doe of Gommercially available LCGS also Inter EDS andytes EBN-1.
Ight Hoterophile onlined the Heterophile antibody.

| EBV Serological
Status | Antibody |
|---------------------------| | | | | | | | Acute | Negative | | | | | Acute | | | | | Late
Acute | Positive | | | | | | | | | | | | Past Infection | | | | | Indeterminant | | EBNA-1 IgG | EBV VCA IgG | EBV EA-D IgG | EBV VCA IgM | Heterophile
------------------|---------------------------------------|-------------|--------------|-------------|-------------------------|
| Negative | Negative | Negative | Positive | Negative |
| Negative | Negative | Negative | Positive | Positive |
| Negative | Negative | Negative | Positive | Positive |
| Primary
| Negative | Positive | Positive | Negative |
| Negative | Negative | Positive | Positive | Positive |
| Negative | Positive | Positive | Positive | Negative |
| Negative | Positive | Positive | Positive | Positive |
| Negative | Positive | Positive | Negative | Positive |
| Positive | Positive | Negative | Negative |
| Positive | Positive | Positive | Positive | Positive |
| Positive | Positive | Positive | Positive | Negative |
| Positive | Positive | Negative | Positive | Positive |
| Positive | Positive | Negative | Positive | Negative |
| Negative | Positive | Negative | Positive | Negative |
| Recovering | Negative | Positive | Positive | Negative | Negative |
| Negative | Positive | Negative | Negative | Negative |
| Positive | Positive | Negative | Negative | Negative |
| No Infection | Negative | Negative | Negative | Negative | Negative |
| Combinations not listed above (n =18) | | | | |

9

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510(k) Summary of Safety and Effectivencss Plexus EBV IgG Multi-Analyte Diagnostics Catalog No. MP0500G Prepared Date: July 17, 2008

Comparison Studies

summarized by analyte.

Page 10 of 17 Performance of the Plexus EBNA-1 IgG and Plexus EA-D IgG analytes were tested against a commercially available ELISA test whereas performance of the Plexus EBV VCA IgG analyte was tested against a combination (hereaffer refered to as 'consenteus predicate') of a FDA-cleared commercially available ELISA, a FDA cleared commercially available immunofluros ent (JPA) est and a FDA cleared commercially available flow cytometry based immunoassay. For each sample, a consensus based alr (1) (2/3) was used to determine the predicate result for comparison with the Plexus VCA IgG result. The Plain Maria Ma United States testing sites: a hospital laboratory located in Northeast, a pediatic hospital laboratory located in the Mid-West, and Fous with serim samples in which EBV tests were ordered. The sera were sequentially submitted to the laboratory, and masked. Samples were collected at three sites and include both prospective (n = 723) and retrospective (n = 150) specimens. Retrospective samples were pre-selected based on EBV VCA Increasons of the form a FDA cleared device . Realts are

EBV VCA IgG vs Consensus Predicate: Comparison by Serological Status (Prospective Population Samples N = 723) Samples were collected and tested by the Northeast investigator (n = 350), Mid-West investigator (n=249),

The following table outlines the positive percent agreements across various serological classifications for prospective samples for VCA (gG analyte when the consensus predicate is used for VCA (gG analysis, Serological status was elermined by the use of commercially available ELISA assays for the EBV analytes EBNA-1 IgG, VCA IgG and VCA IgM and a commercially available heterophile rapid test for the Heterophile antibody.

Table 4: EBV VCA IgG Results
Serostatus by
Predicates			n	Plexus
		Consensus Predicate		Positive	Equivocal	Negative	% Agreement
Acute	Primary
Acute	Positive	57	57	0	0	100%(57/57), 95% CI:93.7-100%
		Negative	1	0	0	1	33.3%(1/3), 95% CI:6.1-79.2%
		No consensus¹	2	2	0	0	NA
Acute	Late
Acute	Positive	72	70	1	1	97.2%(70/72), 95% CI:90.4-99.2%
		Negative	0	0	0	0	NA
		No consensus	0	0	0	0	NA
	Recovering	Positive	1	1	0	0	100%(1/1), 95% CI:20.7-100%
		Negative	0	0	0	0	NA
		No consensus	0	0	0	0	NA
	Previous Infection	Positive	292	282	1	9	96.6%(282/292), 95% CI:93.8-98.1%
		Negative	6	1	0	5	83.3%(5/6), 95% CI:43.6-97%
		No consensus	0	0	0	0	NA
	No Infection	Positive	9	3	0	6	30%(3/10), 95% CI:10.8-60.3%
		Negative	217	13	1	203	93.5%(203/217), 95% CI:89.5-96.1%
		No consensus¹	1	0	0	1	NA
Indeterminate		Positive	50	49	0	1	98%(49/50), 95% CI:89.5-99.6%
		Negative	15	0	0	15	100%(15/15),95% CI:79.6-100%
		No consensus	0	0	0	0	NA

No consensus results: the combination of three predicates could not yeld a conclusive result for these samples – a 2/3 majority could not be obtained.

EBV EBNA-1 vs Predicate: Comparison by Serological Status (Prospective Population Samples N = 723)

Samples were collected and tested by the Northeast investigator (n=249) and Focus (n=249) and Focus (n=124),

The following table outlines the positive percent agreements across various serological classifications for prospective samples for EBNA-1 IgG analyte when a commercial ELISA test is used as a predicate for EBNA-1 IgG analysis. Serological status was deternined by the use of commercially available ELISA assays for the EBV analytes EBNA-1 IgG, VCA IgG and VCA IgM and a commercially available heterophile rapid test for the Heterophile antibody.

10

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510(k) Summary of Safety and Effectiveness Plexus EBV IgG Multi-Analyte Diagnostics Catalog No. MP0500G Prepared Date: July 17, 2008

Page 11 of 17

	Table 5: EBV EBNA-1 IgG Results
		Predicate ELISA		Plexus
Serological
Status by
Predicates			n	Positive	Equivocal	Negative	% Agreement
	Positive	Positive	0	0	0	0	NA
	Primary
Acute	Equivocal	0	0	0	0	NA
Acute		Negative	60	0	0	60	100%(60/60), 95% CI:94-100%
		Positive	69	65	0	4	94.2%(65/69), 95% CI:86-97.7%
	Late
Acute	Equivocal	0	0	0	0	NA
		Negative	3	0	0	3	100%(3/3), 95% CI:43.8-100%
		Positive	0	0	0	0	NA
	Recovering	Equivocal	0	0	0	0	NA
		Negative	1	0	0	1	100%(1/1), 95% CI:20.7-100%
		Positive	284	266	2	16	93.7%(266/284), 95% CI:90.2-96%
	Previous
Infection	Equivocal	0	0	0	0	NA
		Negative	14	1	0	13	92.9%(13/14), 95% CI:68.5-98.7%
		Positive	0	0	0	0	NA
	No Infection	Equivocal	0	0	0	0	NA
		Negative	227	1	0	226	99.6%(226/227), 95% CI:97.5-99.9%
Indeterminate		Positive	36	29	0	7	76.3%(29/38), 95% CI:60.8-87%
		Equivocal	2	0	0	2	0%(0/2), 95% CI:0-65.8%
		Negative	27	0	0	27	100%(27/27), 95% CI:87.5-100%

11

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510(k) Summary of Safety and Effectiveness Plexus EBV IgG Multi-Analyte Diagnostics Catalog No. MP0500G

Prepared Date: July 17, 2008 Page 12 of 17

EBV EA-D vs Predicate: Comparison by Serological Status (Prospective Population Samples N = 723) Samples were collected and tested by the Northeast investigator (nestigator (nvestigator (nvestigator (n=249) and Focus (n=124).

The following table outlines the positive percent agreements across various serological classifications for prospective samples for EA-D IgG and regal EU SA Lest is used as a predicate for EA-D IgG analysis. Serological status and determined by the use of commercially available ELISA assas for the EBV andres EBNA-1 (gG, VCA IgG, EA-D (gG, EA-D (gG, EA-D (gG, EA-D (gG, EA-D (gG, EA-D (gG, EA-D (gG, EA-D IgM and a commercially available heterophile rapid test for the Heterophile antibody.

Table 6: EBV EA-D IgG Results
Serological
Status by
Predicates		Plexus				% Agreement
		Predicate ELISA	n	Positive	Equivocal		Negative
Acute	Positive	43	40	0	3	93%(40/43), 95% CI:81.4-97.6%
	Primary
Acute	Equivocal	0	0	0	0	NA
		Negative	17	4	0	13	76.5%(13/17), 95% CI:52.7-90.4%
Acute	Positive	51	41	1	9	80.4%(41/51), 95% CI:67.5-89%
	Late
Acute	Equivocal	0	0	0	0	NA
		Negative	21	2	2	17	81%(17/21), 95% CI:60-92.3%
Recovering	Positive	1	0	0	1	0%(0/1), 95% CI:0-79.3%
		Equivocal	0	0	0	0	NA
		Negative	0	0	0	0	NA
Previous Infection	Positive	0	0	0	0	NA
		Equivocal	0	0	0	0	NA
		Negative	298	11	1	286	96%(286/298), 95% CI:93.1-97.7%
No Infection	Positive	0	0	0	0	NA
		Equivocal	0	0	0	0	NA
		Negative	227	1	3	223	98.2%(223/227), 95% CI:95.6-99.3%
Indeterminate	Positive	12	7	0	5	26.9%(7/26), 95% CI:13.7-46.1%
		Equivocal	30	14	2	14	6.3%(2/32), 95% CI:1.7-20.1%
		Negative	23	0	0	23	62.2%(23/37), 95% CI:46.1-75.9%

12

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510(k) Summary of Safety and Effectiveness Plexus EBV IgG Multi-Analyte Diagnostics Catalog No. MP0500G

Prepared Date: July 17, 2008

Page 13 of 17

EBV VCA IgG vs Consensus Predicate: Comparison by Serological Status (Retrospective Presumed Acute Population Samples N = 150)

Samples were collected and tested by Mid-West investigator (n=150).

The following table outlines the positive percent agreements across various serological classifications for retrospective samples for VCA IgG analyte when the consensus predicate is used for VCA IgG analysis. Serological status was delermined by the use of commercially available ELISA assays for the EBV analytes EBNA-1 IgG, VCA IgG and VCA IgM and a commercially available heterophile rapid test for the Heterophile antibody.

Table 7: EBV VCA IgG Results
Serostatus by
Predicates	Consensus Predicate	Plexus			% Agreement
		n	Positive	Equivocal		Negative
Acute	Positive	106	99	1	6	93.4%(99/106), 95% CI:87-96.8%
	Negative	0	0	0	0	NA
	No consensus	0	0	0	0	NA
Acute	Positive	8	8	0	0	100%(8/8), 95% CI:67.6-100%
	Negative	0	0	0	0	NA
	No consensus	0	0	0	0	NA
No Infection	Positive	1	1	0	0	100%(1/1), 95% CI:20.7-100%
	Negative	1	1	0	0	0%(0/1), 95% CI:0-79.3%
	No consensus	0	0	0	0	NA
Indeterminate	Positive	33	31	0	2	93.9%(31/33), 95% CI:80.4-98.3%
	Negative	0	0	0	0	NA
	No consensus1	1	1	0	0	NA

No consensus results the combination of three predicates could not yeld a conclusive result for these samples - a 2/3 majority could not be obtained.

13

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510(k) Summary of Safety and Effectiveness

Plexus EBV IgG Multi-Analyte Diagnostics Catalog No. MP0500G

Prepared Date: July 17, 2008 Page 14 of 17

EBY EBNA-1 vs Predicate: Comparison by Serological Status (Retrospective Presumed Acute Population Samples N = 150) Samples were collected and tested by Mid-West investigator (n=150).

The following table outlines the positive percent agreements across various serological classifications for retrospective me lollowing table damos the nagative position is position in the many in EBNA-1 lgC analysis. Serological status was delermined by the use of commercially available ELISA assays for the EBV analytes EBNA-1 1gG, VCA IgG and VCA IgM and a commercially available heterophile rapid test for the Heterophile antibody.

Table 8: EBV EBNA-1 IgG Results
	Predicate ELISA			Plexus
	Serological
Status by
Predicates	n	Positive	Equivocal	Negative	% Agreement
Acute	Primary
Acute	Positive	0	0	0	0	NA
		Equivocal	0	0	0	0	NA
		Negative	106	1	0	105	99.1%(105/106), 95% CI:94.8-99.8%
Acute	Late
Acute	Positive	4	0	0	4	0%(0/4), 95% CI:0-49%
		Equivocal	0	0	0	0	NA
		Negative	4	0	0	4	100%(4/4), 95% CI:51-100%
No Infection		Positive	0	0	0	0	NA
		Equivocal	0	0	0	0	NA
		Negative	2	0	0	2	100%(2/2), 95% CI:34.2-100%
Indeterminate		Positive	4	0	0	4	0%(0/8), 95% CI:0-32.4%
		Equivocal	4	0	0	4	0%(0/4), 95% CI:0-49.0%
		Negative	26	0	0	26	100%(26/26), 95% CI:87.1-100%

14

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510(k) Summary of Safety and Effectiveness

Plexus EBV IgG Multi-Analyte Diagnostics Catalog No. MP0500G

Prepared Date: July 17, 2008 Page 15 of 17

EBY EA-D vs Predicate: Comparison by Serological Status (Retrospective Presumed Acute Population Samples N = 150) Samples were collected and tested by Mid-West investigator (n=150).

The following table outlines the positive percent agreements across various serological classifications for retrospective samples for EA-D IgG analyte when a commercial ELISA test is used as a predicate for EA-D IgG analysis. Serological status was determined by the use of commercially available ELISA assays for the EBV analytes EBNA-1 IgG, VCA IgG, EA-D IgG and VCA IgM and a commercially available heterophile rapid test for the Heterophile antibody.

		Predicate ELISA				Plexus
Serological
Status by
Predicates		n	Positive	Equivocal	Negative

Acute	Primary
Acute	Positive	61	57	1	3	93.4%(57/61), 95% CI:84.3-97.4%
		Equivocal	0	0	0	0	NA
		Negative	45	7	3	35	77.8%(35/45), 95% CI:63.7-87.5%
Acute	Late
Acute	Positive	3	3	0	0	100%(3/3), 95% CI:43.8-100%
		Equivocal	0	0	0	0	NA
		Negative	5	1	0	4	80%(4/5), 95% CI:37.6-96.4%
No Infection		Positive	0	0	0	0	NA
		Equivocal	0	0	0	0	NA
		Negative	2	0	0	2	100%(2/2), 95% CI:34.2-100%
Indeterminate		Positive	10	8	0	2	66.7%(8/12), 95% CI:39.1-86.2%
		Equivocal	14	12	0	2	0%(0/14), 95% CI:0-21.5%
		Negative	10	0	1	9	40.9%(9/22), 95% CI:23.3-61.3%

Inter-laboratory, Intra-assay and Inter-assay Reproducibility

The interlintra-assay reproducibility and the inter-laboratory reproducibility testing were performed at three laboratories. Each of the three laboratories tested twelve samples in triplicate on five different days. The study are summarized in the table below.

Table 16: Inter-laboratory, Intra-assay and Inter-assay Reproducibility
Plexus VCA IgG						Plexus EBNA IgG						Plexus EA IgG
ID	Intra-assay & Inter-assay %CV			Inter-Lab		ID	Intra-assay & Inter-assay %CV			Inter-Lab		ID	Intra-assay & Inter-assay %CV			Inter-Lab
	Mean Index	Intra-assay	Inter-assay	Mean Index	% CV		Mean Index	Intra-assay	Inter-assay	Mean Index	% CV		Mean Index	Intra-assay	Inter-assay	Mean Index	% CV
5	5.38	2.1%	8.1%	5.38	7.4%	12	6.66	2.1%	8.7%	6.66	8.9%	12	4.42	3.9%	7.5%	4.42	2.0%
19	5.12	2.9%	10.0%	5.12	10.1%	15	4.41	4.1%	6.9%	4.42	5.0%	4	2.69	3.6%	19.9%	2.69	7.0%
20	5.02	2.4%	8.4%	5.03	8.1%	8	3.66	2.5%	6.7%	3.66	5.8%	16	1.88	4.7%	7.5%	1.88	4.7%
6	4.21	3.2%	6.7%	4.20	3.7%	4	2.68	5.6%	18.3%	2.67	7.8%	15	1.39	5.6%	15.6%	1.39	15.7%
4	3.37	4.3%	16.6%	3.37	2.5%	18	2.05	3.8%	9.0%	2.05	8.6%	19	0.99	6.0%	12.0%	0.99	7.9%
16	2.21	4.1%	28.4%	2.22	27.0%	5	1.84	3.7%	8.0%	1.84	4.8%	8	0.91	3.7%	8.6%	0.91	2.1%
18	2.11	4.0%	6.0%	2.11	3.7%	6	1.47	5.1%	11.8%	1.46	11.7%	5	0.76	4.7%	12.6%	0.76	5.6%
2	2.01	3.9%	7.9%	2.01	4.4%	2	1.00	4.0%	13.4%	1.00	13.6%	20	0.63	5.3%	8.5%	0.63	2.6%
11	1.16	6.3%	13.3%	1.16	11.9%	3	0.81	6.1%	16.0%	0.81	11.9%	18	0.32	5.3%	9.6%	0.32	6.6%
8	1.11	4.7%	77.0%	1.12	31.1%	16	0.77	6.1%	59.1%	0.77	50.9%	6	0.29	6.1%	33.8%	0.29	4.7%
15	0.38	8.7%	19.6%	0.38	13.4%	20	0.65	5.4%	11.1%	0.65	8.9%	2	0.21	5.2%	61.9%	0.21	12.4%
1	0.17	18.2%	69.2%	0.17	59.3%	9	0.15	9.8%	304.1%	0.15	134%	3	0.21	8.2%	64.6%	0.21	10.1%
9	0.11	15.2%	117.9%	0.11	72.5%	19	0.11	7.8%	23.8%	0.11	19.8%	11	0.18	6.6%	106.1%	0.18	27.0%
3	1.71	5.4%	11.4%	1.71	5.8%	1	0.07	14.0%	41.1%	0.07	34.7%	1	0.15	9.1%	96.5%	0.15	16.9%
12	4.69	2.6%	7.7%	4.69	5.4%	11	0.04	11.2%	32.9%	0.04	23.1%	9	0.10	8.0%	40.1%	0.10	28.1%

15

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510(k) Summary of Safety and Effectiveness Plexus EBV IgG Multi-Analyte Diagnostics Catalog No. MP0500G Prepared Date: July 17, 2008 Page 16 of 17

Inter-Lot Reproducibility

The inter-lot reproducibility was evaluated with fifteen (15) samples in three (3) lots of Plexus EBV kit. The results of the study are summarized in the table below.

Table 10: Inter-lot Reproducibility
	Plexus VCA IgG			Plexus EBNA IgG			Plexus EA-D IgG
ID	Mean	%CV	ID	Mean	%CV	ID	Mean	%CV
5	6.00	3.2%	12	7.35	3.6%	12	4.51	5.3%
19	5.88	2.3%	15	4.76	4.6%	4	2.86	3.3%
20	5.57	2.4%	8	4.01	4.5%	16	1.84	2.0%
12	5.08	3.7%	4	2.62	4.8%	15	1.36	9.0%
6	4.66	3.3%	18	2.39	6.7%	19	1.00	4.6%
4	3.61	1.3%	5	1.66	3.5%	8	0.85	7.2%
18	2.08	3.7%	6	1.44	5.8%	5	0.68	4.8%
2	2.01	2.4%	2	0.93	5.0%	20	0.59	2.3%
16	1.77	4.8%	3	0.74	2.3%	18	0.30	8.6%
3	1.72	4.0%	20	0.58	3.5%	6	0.29	4.2%
11	1.00	3.8%	16	0.36	3.2%	2	0.21	8.3%
8	0.75	2.8%	19	0.10	7.7%	3	0.20	5.8%
15	0.31	7.8%	1	0.06	5.7%	11	0.18	14.4%
1	0.11	7.7%	11	0.04	8.1%	1	0.15	10.8%
9	0.02	0.0%	9	0.02	30.0%	9	0.11	6.4%

Cross-Reactivity

A cross-reactivity study was performed to determine if samples from various disease states and other potentially cross-reactivity factors interfere with test results when tested with the Plexus EBV IgG kit. A panel of (ANA= 28, CMV= 31, HSV-2=13, HSV-6= 4, Rubeola Virus =1, Rubella Virus=39, Toxoplasma gondii =19, and VZA= 35) samples for each cross reactant were evaluated for possible cross reactivity with the Plexus EBV IgG kit for each of the three (VCA, EA-D and EBNA-1) IgG analyte. Of the 107 samples tested, 41 were prescreened for EBV IgG negativity. Because of the high prevalence of EBV IgG antibodies in Of the for bangles total 11 The proof only in 19 mornerially available ELISA. The majority of all samples that did elicit a positive result were also confirmed positive by the corresponding commercially available ELISA, indicating reactivity to EV IgG antibodies rather than cross reactivity with a potentially interfering factor.

Cross Reactives	N	Method	EBV VCA IgG			EBV EBNA IgG			EBV EAD IgG
			Positive	Equivocal	Negative	Positive	Equivocal	Negative	Positive	Equivocal	Negative
ANA	28	Plexus	27	0	1	28	0	0	8	0	20
		ELISA	28	0	0	28	0	0	5	5	18
		Discrepants		1			0			65
Cytomegalovirus
(CMV)		Plexus	24	1	6	24	0	7	4	0	27
	31	ELISA	26	0	5	25	0	6	3	1	27
		Discrepants		21			1			21
HSV-1	29	Plexus	27	1	1	26	0	2	3	1	25
		ELISA	27	0	2	28	1	1	3	0	26
		Discrepants		21			21			11
HSV-2	13	Plexus	13	0	0	12	0	1	2	3	8
		ELISA	13	0	0	13	0	0	2	1	10
		Discrepants		0			1			44
HHV-6		Plexus	0	0	4	0	0	4	0	0	4
	4	ELISA	0	0	4	0	0	4	0	0	4
		Discrepants		0			0			0
Measles
(Rubeola)		Plexus	0	0	1	0	0	1	0	0	1
	1	ELISA	0	0	1	0	0	1	0	0	1
		Discrepants		0			0			0

16

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510(k) Summary of Safety and Effectiveness Plexus EBV IgG Multi-Analyte Diagnostics Catalog No. MP0500G Prepared Date: July 17, 2008 Page 17 of 17

				Table 11: Cross-Reactivity
Cross Reactives	N	Method	EBV VCA IgG			EBV EBNA IgG			EBV EAD IgG
			Positive	Equivocal	Negative	Positive	Equivocal	Negative	Positive	Equivocal	Negative
Mumps	1	Plexus	0	0	1	0	0	1	0	0	1
		ELISA	0	0	1	0	0	1	0	0	1
		Discrepants	0			0			0
Rubella Virus	39	Plexus	26	0	13	25	1	13	4	1	34
		ELISA	26	1	12	27	0	12	3	2	34
		Discrepants	81			21			11
Toxoplasma
gondii	19	Plexus	17	0	2	18	0	1	1	4	14
		ELISA	19	0	0	18	0	1	1	2	16
		Discrepants	2			0			44
Varicella-zoster
(VZV)	35	Plexus	26	0	9	22	0	13	4	1	30
		ELISA	24	0	11	22	0	13	4	2	29
		Discrepants	4			0			43

One Equivocal Sample; Two Equivocal Samples; Three Equivocal Samples; Four Equivocal Samples

Sample Storage and Handling

Fifteen (15) neqative and positive for EBV IgG samples were used to assess the reactivity of unfrozen samples that were frozen and thawed for up to five cycles. No effect was observed for any of the freeze-thaw cycling in either the positive or negative sample.

Interference

The test performance was evaluated with the presence of interfering substances. Four samples, two positive for EBV IgG antibodies by Plexus EBV IgG were used in the study. Baseline levels for triglycerides, albumin, bilirubin, and hemoglobin were established for each sample. The remaining serum was spiked with purchased interfering substances at levels that exceeded the expected human range. The spiked samples were tested again in the assay to determine if the elevated levels of interfering substances affected the assay. No interference was observed for any of the interfering substances in either the positive or negative sample.

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Image /page/17/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of the department's name, which is arranged in a circular pattern around the logo. The text reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES - USA'.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Focus Diagnostics, Inc. C/O Constance Bridges 10703 Progress Way Cypress, California 90630

JUL 2 8 2008

Re: K073382

Trade/Device Name: Plexus EBV IgG Multi-Analyte Diagnostics Regulation Number: 21 CFR 866.3235 Regulation Name: Epstein-Barr Virus Serological Device Regulatory Class: Class I Product Code: LSE Dated: November 30, 2007 Received: December 3, 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 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 or uny I eath all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice or requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements begin marketing your device as described in your Section 510(k) premarket

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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 vour 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 attaym

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

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510(k) Number (if known):

KO73382

Device Name:

Plexus EBV IgG Multi-Analyte Diagnostics

Focus Diagnostics' Plexus™ EBV IgG Multi-Analyte Diagnostics test kit Indications for Use: is intended for qualitatively detecting the presence or absence of human IgG class antibodies to viral capsid antigen (VCA), early antigen- diffuse (EA-D), and nuclear antigen (EBNA-1) of Epstein-Barr virus in human sera. The test is indicated as an aid in the diagnosis of EBV infection and EBV-associated infectious mononucleosis.

The performance of this assay has not been established for use in the diagnosis of nasopharyngeal carcinoma and Burkitt's lymphoma, for testing of immunocompromised patients, for use by a point of care facility or for use with automated equipment. This assay has not been evaluated for donor screening.

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)

Soucas
Division Sign-Off

ffice of In Vitro Diaan Evaluation and Sc

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510(k) K073362