Predicate Devices

Osom® Mono Test, Diamedix EBV VCA IgM ELISA, Athena Multi-Lyte EBV VCA IgM Test System

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard immunoassay technology and data analysis based on comparing fluorescence measurements to a cutoff calibrator. There is no mention of AI, ML, or any related concepts in the device description or performance studies.

Therapeutic

No.
This device is a diagnostic test kit intended to aid in the diagnosis of EBV infection and EBV-associated infectious mononucleosis by detecting specific antibodies, not to treat or prevent a disease or condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the test kit "is intended as an aid in the diagnosis of EBV infection and EBV-associated infectious mononucleosis." This clearly indicates its purpose is to help identify a medical condition.

SaMD (Software as a Medical Device)

No

The device is a test kit that uses antigen beads and chemical reactions to detect antibodies in human sera, which are physical components and processes, 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 that the device is "intended for qualitatively detecting the presence or absence of human IgM class antibodies to viral capsid antigen (VCA), and heterophile antibodies in human sera." It is also indicated as "an aid in the diagnosis of EBV infection and EBV-associated infectious mononucleosis." This clearly describes a test performed on a biological sample (human sera) outside of the body to provide information for diagnosis.
Device Description: The description details a "Multiplexed Immunoassay for the Qualitative Detection of Human IgM Antibodies to Epstein-Barr Virus." Immunoassays performed on biological samples are a common type of IVD.
Methodology: The three-step procedure involves incubating patient sera with antigen beads, adding a conjugate, and measuring fluorescence. This is a typical laboratory-based diagnostic test performed on a biological specimen.
Performance Studies: The document describes performance studies comparing the device to predicate devices (which are also IVDs) using biological samples (sera) to evaluate its accuracy in detecting the target analytes.

All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Focus Diagnostics' Plexus™ EBV IgM Multi-Analyte Diagnostics test kit is intended for qualitatively detecting the presence or absence of human IgM class antibodies to viral capsid antigen (VCA), and heterophile antibodies 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 cstablished 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 (comma separated list FDA assigned to the subject device)

LJN

Device Description

Multiplexed Immunoassay for the Qualitative Detection of Human IgM 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

Prospective Population Samples: Plexus EBV vs. Consensus Predicate for VCA IgM analyte (N = 723) Samples were collected and tested by the Northeast investigator (n = 350), Mid-West investigator (n=249) and Focus (n=124).

Prospective Population Samples: Plexus EBV vs. Heterophile Rapid Test for Heterophile IgM analyte (N = 723) Samples were collected and tested by the Northeast investigator (n = 350), Mid-West investigator (n=249) and Focus (n=124).

Presumed Acute Retrospective Samples: Plexus EBV vs. Consensus Predicate for VCA IgM analyte Samples were collected and tested by Mid-West investigator (n=150).

Presumed Acute Retrospective Samples: Plexus EBV vs. Heterophile Rapid Test for Heterophile IgM analyte Samples were collected and tested by Mid-West investigator (n=150).

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

Comparison Studies:
Performance of the Plexus EBV VCA IgM analyte was tested against a combination (hereafter referred to as 'consensus predicate') of a FDA-cleared commercially available ELISA, a FDA cleared commercially available immunofluroscent (IFA) test and a FDA cleared commercially available flow cytomcery based immunoassay. For each sample, a consensus based algorithm (2/3) was used to determine the predicate result for comparison with the Plexus VCA IgM result. The Plexus EBV Heterophile IgM analyte was tested against a FDA cleared heterophile rapid test. The studies were conducted at three United States testing sites: a hospital laboratory located in Northeast. a pediatric hospital laboratory located in the Mid-West, and Focus with serum samples in which EBV tests were ordered. The sera were sequentially submitted to the laboratory, archived, and masked, Samples were collected at three sites and include both prospective (n = 723) and retrospective (n = 150) specimens. The Plexus EBV IgM tests were run in conjunction with the Plexus EBV IgG tests for a complete antibody profile. The samples were then classified into EBV infection status using the Serological Status table above.

Prospective Population Samples: Plexus EBV vs. Consensus Predicate for VCA IgM analyte (N = 723)
Table 4: EBV VCA IgM Results

Consensus Predicate	n	Positive	Equivocal	Negative	% Agreement
Positive	88	79	3	6	85.9%(79/92), 95% CI:77.3-91.6%
Negative	630	12	1	617	97.8%(617/631), 95% CI:96. 3-98.7%
No consensus1	5	1	0	4	NA

Prospective Population Samples: Plexus EBV vs. Heterophile Rapid Test for Heterophile IgM analyte (N = 723)
Table 5: EBV Heterophile Results

Predicate Rapid Test	n	Positive	Negative	% Agreement
Positive	75	60	15	80%(60/75), 95% CI:69.6-87.5%
Equivocal	0	0	0	N/A
Negative	648	7	641	98.9%(641/648), 95% CI:97.8-99.5%

Presumed Acute Retrospective Samples: Plexus EBV vs. Consensus Predicate for VCA IgM analyte

Consensus Predicate	n	Positive	Negative	% Agreement
Positive	143	140	3	97.2%(140/144), 95% CI:93.1-98.9%
Negative	5	3	2	33.3%(2/6), 95% CI:9.7-70.0%
No consensus1	2	1	1	NA

Presumed Acute Retrospective Samples: Plexus EBV vs. Heterophile Rapid Test for Heterophile IgM analyte
Table 8: EBV Heterophile Results

Predicate Rapid Test	n	Positive	Equivocal	Negative	% Agreement
Positive	112	98	3	11	87.5%(98/112), 95% CI:80.1-92.4%
Negative	38	3	0	35	92.1%(35/38), 95% CI:79.2-97.3%

Inter-laboratory, Intra-assay and Inter-assay Reproducibility
The interfintra-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.

Inter-Lot Reproducibility
The inter-lot reproducibility was evaluated with eleven (11) samples in triplicates on three (3) lots of Plexus EBV kit.

Cross-Reactivity
A cross-reactivity study was performed to determine if samples disease states and other potentially cross-reactivity factors interfere with test results when tested with the Plexus EBV IgM kit. A panel of (Antinuclear Antibody test (ANA) n=28, Cytomegalovirus (CMV) n=25, Herpes Simplex Virus-1 (HSV-1) and Herpes Simplex Virus-2 (HSV-2) n =2, Rheumatoid Factor (Rh) n=29, Rubella Virus n=5, and Varicella-Zoster Virus (VZV) n=42). samples for each cross reactant were evaluated for possible cross reactivity with the Plexus EBV IgM kit for each of the two (VCA and Heterophile) IgM analyte. The test samples were also evaluated on commercially available ELISA and heterophile rapid test.

Sample Storage and Handling
Fifteen (15) negative and positive for EBV IgM samples were used to assess the reactivity of unfrozen sample against samples that were frozen and thawed for up to five cycles. No effect was observed for any of the freezethaw cycling in either the positive or negative sample.

Interference
The test performance was evaluated with the presence of interfering substances. Four samples, two positive and two negative for EBV VCA IgM and heterophile antibody by Plexus EBV IgM were used in the study. Baseline ERV IgM levels were established for each sample before interferents were added. Two concentration levels of each interferent were used: triglycerides (1 mg/mL), albumin (6 mg/mL and 60 mg/mL), bilirubin (0.02 mg/mL and 0.2 mg/mL), and hemoglobin (22 mg/mL) The higher interferent concentrations represent levels that exceed the expected human range. All samples were evaluated to determine if these interfering substances affect the assay. No interference was observed for any of the substances in either the positive or negative sample.

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

See tables in "Summary of Performance Studies" for positive and negative percent agreements and 95% CI.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Osom® Mono Test, Diamedix EBV VCA IgM ELISA, Athena Multi-Lyte EBV VCA IgM Test System

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

510(k) Summary of Safety and Effectiveness Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M Prepared Date: July 22, 2008 Page 1 of 13

| Applicant | Focus Diagnostics, Inc.
10703 Progress Way
Cypress, California 90630
USA | |
|--------------------------------|--------------------------------------------------------------------------------------------|--------------|
| Establishment Registration No. | 2023365 | AUG - 4 2008 |
| Contact Person | Constance Bridges
tel 714.220.1900
fax 714.995.6921
cbridges@focusdx.com | |
| Summary Date | June 27, 2008 | |
| Proprietary Name | Plexus EBV IgM Multi-Analyte Diagnostics | |
| Generic Name | Epstein-Barr Virus Serological Assays | |
| Classification | Class I | |
| Predicate Devices | Osom® Mono Test
Diamedix EBV VCA IgM ELISA
Athena Multi-Lyte EBV VCA IgM Test System | |

Device Description

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

Intended Use

Focus Diagnostics' Plexus™ EBV IgM Multi-Analyte Diagnostics test kit is intended for qualitatively detecting the presence or absence of human IgM class antibodies to viral capsid antigen (VCA), and heterophile antibodies in human sera. The test is indicated as an aid in the diagnosis of EBV infection and EBV-associated infectious mononucleosis.

Epstein-Barr Virus VCA (IgM) Recomb Immun Antibod

The performance of this assay has not been cstablished 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.

The Focus Diagnostics Plexus™ EBV IgM uses an Antigen Bead suspension that contains two distinct EBV antigen bead types (VCA and Heterophile) and one process control bead type that fluoresce at different wavelengths and/or intensities.

The Focus Diagnostics Plexus™ EBV IgM is a three step procedure.

1. Patient sera are diluted, and the diluted sera are incubated with Antigen Beads. If EBV antibodies are present, then the antibodies bind to the corresponding antigen beads.
1. Phycoerythrin-conjugated goat Anti-human IgM (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 features the word "FOCUS" in a bold, sans-serif font, with a curved graphic element above and to the left of the word. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin line. The overall design is simple and professional.

510(k) Summary of Safety and Effectiveness Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M Prepared Date: July 22, 2008 Page 2 of 13

Comparison with Predicate Devices: VCA IgM analyte:

Item	Device	Predicates
Name	Plexus™ EBV IgM
Multi-Analyte
Diagnostics	Diamedix VCA IgM,
ELISA	Athena Multi-Lyte
EBV VCA IgM Test
System	Epstein-Barr Virus
VCA (IgM) Recomb
Immun Antibod
(IFA)
	Similarities between Device and Predicate
Intended use	Focus Diagnostics'
Plexus™ EBV (VCA)
IgM Multi-Analyte
Diagnostics test kit is
intended for
qualitatively detecting
the presence or absence
of human IgM class
antibodies to viral capsid
antigen (VCA), and
heterophile antibodies 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 IgM ELISA is
intended for the
qualitative and semi-
quantitative determination
of IgM antibodies to
Epstein-Barr Virus
(recombinant) viral capsid
antigen (EBV-VCA IgM)
in human serum by
indirect enzyme
immunoassay. The Is-
EBV-VCA IgM test kit
may be used in
combination with other
Epstein-Barr serologies,
Viral Capsid Antigen
(VCA) IgG, 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 VCA
IgM Test System is a
microparticle-based
immunoassay
intended for the
qualitative detection
of IgM class antibody
to Epstein-Barr virus,
viral capsid antigen in
human serum. The
test system is
intended to be used
for the laboratory
diagnosis of EBV-
associated infectious
mononucleosis and
provides
epidemiological
information on the
diseases 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 device is
indicated for
laboratory diagnosis
of EBV-associated
infectious
mononucleosis and to
provide
epidemiological
information on the
diseases caused by
Epstein-Barr virus	The test is indicated as
an aid in the clinical
diagnosis of infectious
mononucleosis.
Immunoglobulin
Type	IgM	IgM	IgM	IgM
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	EBV-VCA: Recombinant
47 kDa fusion half of p18	EBV VCA pg125	Recombinant VCA
antigen (rVCA)
Item	Device	Predicates
Name	Plexus™ EBV IgM
Multi-Analyte
Diagnostics	Diamedix VCA IgM,
ELISA	Athena Multi-Lyte
EBV VCA IgM Test
System	Epstein-Barr Virus
VCA (IgM) Recomb
Immun Antibod
(IFA)
	antigen
Strain	N/A- purified protein	N/A- Recombinant protein	N/A native protein	N/A- Recombinant
protein
Host Cell Line	EBV-VCA: Native
(P3H3 or P3HR-1)	EBV-VCA: E. coli
(unknown)	Unknown	Mammalian cell line
Methodology	Multiplex Microbead
Immunoassay (MMIA)
based on Luminex XMAP
technology	Enzyme Immunoassay
technology.	Flow cytometry
immunoassay	Indirect
Immunofluorescence
Antibody Test
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 logo features the word "FOCUS" in bold, uppercase letters. A curved, swooping line extends from the left side of the "F", arcing over the word. Below "FOCUS" is the word "Diagnostics" in a smaller, less bold font, underlined with a thin line.

510(k) Summary of Safety and Effectiveness Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M Prepared Date: July 22, 2008

Page 3 of 13

Comparison with Predicate Devices: Heterophile IgM analyte:

Item	Device	Predicate
Name	Plexus™ EBV IgM Multi-Analyte
Diagnostics	Osom® Mono Test, Heterophile
Similarity between Device and Predicate
Intended use	Focus Diagnostics' Plexus™ EBV
(Heterophile) IgM Multi-Analyte Diagnostics
test kit is intended for qualitatively detecting
the presence or absence of human IgM class
antibodies to viral capsid antigen (VCA), and
heterophile antibodies in human sera. The test
is indicated as an aid in the diagnosis of EBV
infection and EBV-associated infectious
mononucleosis.	The OSOM Mono Test is intended for the quantitative
detection infectious mononucleosis heterophile
antibodies in serum, plasma and whole blood as an aid
in the 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.	Intended to make a serological diagnosis of EBV
infections
Immunoglobulin
Type	IgM	IgM
Difference between Device and Predicate
Sample matrix	Serum	Serum / Plasma / Whole Blood
CLIA complexity	High	Moderate
Methodology	Multiplex Microbead Immunoassay (MMIA)
based on Luminex XMAP technology.	Immunocheomatorgraphic Test

:

3

Image /page/3/Picture/0 description: The image shows the logo for Focus Diagnostics. The logo consists of the word "FOCUS" in bold, sans-serif font, with a curved graphic element above and to the left of the word. Below the word "FOCUS" is the word "Diagnostics" in a smaller, less bold font, underlined by a thin line. The overall design is simple and professional.

510(k) Summary of Safety and Effectiveness Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M

Prepared Date: July 22, 2008

Page 4 of 13

Item	Device	Predicate
Name	Plexus™ EBV IgM Multi-Analyte
Diagnostics	Osom® Mono Test, Heterophile
Strain	NA purified protein	NA native protein
Host Cell Line	Purified from bovine red blood cells	Extract of bovine erythrocytes
Antigen	Heterophile: purified protein	Heterophile: native protein
Interpretation of
test results	Perform automated calculations using Plexus
software.	Visual evaluation

EXPECTED VALUES

Outside investigators assessed the device with prospective masked sequential samples that were submitted for routine EBV testing (n=723.) The prevalence of EBV 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 Spstein-Barr serologies (VCA) IgG and IgM, Epstein-Barr Nuclear Antigen-1 (EBNA-1) IgG, Early Antigen-Diffuse (EA-D) IgG and a heterophile rapid antibody test. The observed prevalence is in Table 1. Expected values are presented by age and gender in the tables below for serum sample from a Total Population (N= 723). For all analytes, index values of 1.10 are positives.

Table 1: Observed Prevalence – EBV Plexus
	VCA IgM	Heterophile
Positive	12.7% (92/723)	9.3% (67/723)
Equivocal	0.6% (4/723)	0% (0/723)
Negative	86.7% (627/723)	90.7% (656/723)

Table 2: EBV Plexus Results VCA IgM
		Positive		Equivocal		Negative
Age	Gender	n	%	n	%	n	%	Total
70	F	0	0	0	0	7	100	7
>70	M	1	11.1	0	0	8	88.9	9
Total		92	12.7	4	0.6	627	86.7	723

Table 3: EBV Plexus Results Heterophile IgM
Age	Gender	Positive		Equivocal		Negative		Total
		n	%	n	%	n	%
70	F	0	0	0	0	7	100	7
>70	M	0	0	0	0	9	100	9
Total		67	9.3	0	0	656	90.7	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

5

Image /page/5/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 is a curved, swooping shape. Below the word "FOCUS" is the word "Diagnostics" in a smaller, less bold font, underlined with a thin line.

510(k) Summary of Safety and Effectiveness Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M Prepared Date: July 22, 2008 Page 6 of 13

Image /page/5/Figure/3 description: The image is a bar graph titled "Distribution of Patient Age". The x-axis is labeled "Age" and shows age ranges from 1-5 to 85-90. The y-axis is labeled "Frequency" and ranges from 0 to 300. The bar graph shows that the highest frequency of patients is in the 16-20 age range, with a frequency of approximately 240.

6

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. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font with a line above it. To the left of the word "FOCUS" is a curved, black shape that resembles a crescent.

510(k) Summary of Safety and Effectiveness Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M Prepared Date: July 22, 2008

Page 7 of 13

PERFORMANCE CHARACTERISTICS

Typical Antibody Response Classification

The table below summarizes a generally accepted algoritum for classifying the EBV infection status via EBV serologic profiles.

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

Comparison Studies

Performance of the Plexus EBV VCA IgM analyte was tested against a combination (hereafter referred to as 'consensus predicate') of a FDA-cleared commercially available ELISA, a FDA cleared commercially available immunofluroscent (IFA) test and a FDA cleared commercially available flow cytomcery based immunoassay. For each sample, a consensus based algorithm (2/3) was used to determine the predicate result for comparison with the Plexus VCA IgM result. The Plexus EBV Heterophile IgM analyte was tested against a FDA cleared heterophile rapid test. The studies were conducted at three United States testing sites: a hospital laboratory located in Northeast. a pediatric hospital laboratory located in the Mid-West, and Focus with serum samples in which EBV tests were ordered. The sera were sequentially submitted to the laboratory, archived, and masked, Samples were collected at three sites and include both prospective (n = 723) and retrospective (n = 150) specimens. The Plexus EBV IgM tests were run in conjunction with the Plexus EBV IgG tests for a complete antibody profile. The samples were then classified into EBV infection status using the Serological Status table above.

Prospective Population Samples: Plexus EBV vs. Consensus Predicate for VCA IgM analyte (N = 723) Samples were collected and tested by the Northeast investigator (n = 350), Mid-West investigator (n=249) and Focus (n=124).

The following table outlines the positive and negative percent agreements for prospective samples for VCA IgM analyte when the consensus predicate is used for VCA IgM analysis.

Table 4: EBV VCA IgM Results
Consensus Predicate	n	Positive	Equivocal	Negative	% Agreement
Positive	88	79	3	6	85.9%(79/92), 95% CI:77.3-91.6%
Negative	630	12	1	617	97.8%(617/631), 95% CI:96. 3-98.7%

7

Image /page/7/Picture/1 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in large, bold, sans-serif font. Below the word "FOCUS" is a horizontal line, and below the line is the word "Diagnostics" in a smaller, sans-serif font. To the left of the word "FOCUS" is a curved, crescent-shaped graphic element.

510(k) Summary of Safety and Effectiveness Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M

Prepared Date: July 22, 2008

Page 8 of 13

Table 4: EBV VCA IgM Results
Consensus Predicate	n	Plexus
		Positive	Equivocal	Negative	% Agreement
No consensus1	5	1	0	4	NA

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

Prospective Population Samples: Plexus EBV vs. Heterophile Rapid Test for Heterophile IgM analyte (N = 723) Samples were collected and tested by the Northeast investigator (n = 350), Mid-West investigator (n=249) and Focus (n=124).

The following table outlines the positive percent agreements for prospective samples for Heterophile IgM analyte when the Heterophile rapid test is used as predicate for Heterophile IgM analysis and consensus predicate is used for VCA IgM analysis.

Table 5: EBV Heterophile Results
Predicate Rapid Test	n	Positive	Equivocal	Negative	% Agreement
Positive	75	60	0	15	80%(60/75), 95% CI:69.6-87.5%
Equivocal	0	0	0	0	N/A
Negative	648	7	0	641	98.9%(641/648), 95% CI:97.8-99.5%

Prospective Population Samples: Plexus EBV vs. Consensus Predicate for VCA IgM analyte (by Serological Status) (N = 723)

Samples were collected and tested by the Northeast investigator (n = 350), Mid-West investigator (n=249) and Focus (n=124).

The following table outlines the positive percent agreements across various serological classifications for prospective samples for VCA IgM analyte when the consensus predicate is used for VCA IgM analysis.

Table 6: EBV VCA IgM Results
Serostatus by Predicates	Consensus Predicate	n	Plexus			% Agreement
			Positive	Equivocal	Negative
Acute	Positive	59	56	2	1	94.9%(56/59), 95% CI:86.1-98.3%
	Negative	1	0	0	1	100%(1/1), 95% CI:20.7-100%
	No consensus	0	0	0	0	NA
Acute	Positive	14	9	1	4	64.3%(9/14), 95% CI:38.8-83.7%
	Negative	58	2	0	56	96.6%(56/58), 95% CI:88.3-99%
	No consensus	0	0	0	0	NA
Recovering	Positive	0	0	0	0	NA
Recovering	Negative	1	0	0	1	100%(1/1), 95% CI:20.7-100%
Recovering	No consensus	0	0	0	0	NA
Previous Infection	Positive	1	0	0	1	0%(0/1), 95% CI:0-79.3%
Previous Infection	Negative	296	9	1	286	96.3%(286/297), 95% CI:93.5-97.9%
Previous Infection	No consensus1	1	1	0	0	NA
No Infection	Positive	1	1	0	0	50%(1/2), 95% CI:9.5-90.5%

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Image /page/8/Picture/1 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, sans-serif font, with a curved graphic element above and to the left of the word. Below "FOCUS" is the word "Diagnostics" in a smaller, sans-serif font, underlined with a thin line. The overall design is simple and professional.

510(k) Summary of Safety and Effectiveness Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M Prepared Date: July 22, 2008

Page 9 of 13

	Table 6: EBV VCA IgM Results
	Consensus Predicate		Plexus
Serostatus by
Predicates		n	Positive	Equivocal	Negative	% Agreement
No Infection	Negative	225	0	0	225	100%(225/225), 95% CI:98.3-100%
No Infection	No consensus1	1	0	0	1	NA
Indeterminate	Positive	13	13	0	0	81.3%(13/16), 95% CI:57.0-93.4%
Indeterminate	Negative	49	1	0	48	98%(48/49), 95% CI:89.3-99.6%
Indeterminate	No consensus1	3	0	0	3	NA

1 No consensus results: the combination of three predicates could not yied a conclusive result for these sumples - a 2/3 majority could not he obtained.

Prospective Population Samples: Plexus EBV vs. Heterophile IgM analyte (by Serological Status) (N = 723)

Samples were collected and tested by the Northeast investigator (n = 350), Mid-West investigator (n=249), and Focus (n=124).

The following table outlines the positive percent agreements across various scrological classifications for prospective samples for Heterophile IgM analyte when the Heterophile rapid test is used as predicate for Heterophile IgM analysis and consensus predicate is used for VCA IgM analysis.

| Predicate Heterophile

Rapid Test				Plexus			Table 7: EBV Heterophile IgM Results
Serological Status by
Predicates		Primary Acute	n	Positive	Equivocal	Negative	% Agreement
		Positive	51	48	0	3	94.1%(48/51), 95% CI:84.1-98%
	Primary
Acute	Equivocal	0	0	0	0	NA
		Negative	9	1	0	8	88.9%(8/9), 95% CI:56.5-98%
Acute		Positive	5	2	0	3	40%(2/5), 95% CI:11.8-76.9%
	Late
Acute	Equivocal	0	0	0	0	NA
		Negative	67	1	0	66	98.5%(66/67), 95% CI:92-99.7%
Recovering		Positive	0	0	0	0	NA
		Equivocal	0	0	0	0	NA
		Negative	1	0	0	1	100%(1/1), 95% CI:20.7-100%
Previous Infection		Positive	0	0	0	0	NA
		Equivocal	0	0	0	0	NA
		Negative	298	2	0	296	99.3%(296/298), 95% CI:97.6-99.8%
No Infection		Positive	0	0	0	0	NA
		Equivocal	0	0	0	0	NA
		Negative	227	3	0	224	98.7%(224/227), 95% CI:96.2-99.5%
		Positive	19	10	0	9	52.6%(10/19), 95% CI:31.7-72.7%
	Indeterminate	Equivocal	0	0	0	0	NA
		Negative	46	0	0	46	100%(46/46), 95% CI:92.3-100%

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Image /page/9/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 positioned to the left of the word "FOCUS", resembling a stylized check mark or swoosh. A horizontal line separates the word "FOCUS" from the word "Diagnostics".

K073381 510(k) Summary of Safety and Effectiveness

Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M Prepared Date: July 22, 2008 Page 10 of 13

Presumed Acute Retrospective Samples: Plexus EBV vs. Consensus Predicate for VCA IgM analyte Samples were collected and tested by Mid-West investigator (n=150).

The following table outlines the positive and negative percent agreements for retrospective samples for VCA IgM analyte when the consensus predicate is used for VCA IgM analysis.

Consensus Predicate	n	Plexus			% Agreement
		Positive	Equivocal	Negative
Positive	143	140	0	3	97.2%(140/144), 95% CI:93.1-98.9%
Negative	5	3	0	2	33.3%(2/6), 95% CI:9.7-70.0%
No consensus1	2	1	0	1	NA

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

Presumed Acute Retrospective Samples: Plexus EBV vs. Heterophile Rapid Test for Heterophile IgM analyte Samples were collected and tested by Mid-West investigator (n=150).

The following table outlines the positive and negative percents for retrospective samples for Heterophile IgM analyte when the Heterophile rapid test is used as predicate for Heterophile IgM analysis and consemasus predicate is used for VCA IgM analysis.

Table 8: EBV Heterophile Results
Predicate Rapid Test	n	Plexus			% Agreement
		Positive	Equivocal	Negative
Positive	112	98	3	11	87.5%(98/112), 95% CI:80.1-92.4%
Negative	38	3	0	35	92.1%(35/38), 95% CI:79.2-97.3%

Presumed Acute Retrospective Samples: Plexus EBV vs. Consensus Predicate for VCA IgM analyte (by Serological Status)

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

The following table outlines the positive percent agreements across various scrological classifications for retrospective samples for VCA IgM analyte when the consensus predicate is used for VCA IgM analysis,

							Table 9: EBV VCA IgM Results

Serological Status by
Predicates		Consensus Predicate	n	Plexus			% Agreement
				Positive	Equivocal	Negative
Acute	Primary
Acute	Positive	104	103	0	1	99%(103/104), 95% CI:94.8-99.8%
		Negative	1	0	0	1	50%(1/2), 95% CI:9.5-90.5%
		No consensus1	1	1	0	0	NA
Acute	Late
Acute	Positive	8	7	0	1	87.5%(7/8), 95% CI:52.9-97.8%
		Negative	0	0	0	0	NA
		No consensus	0	0	0	0	NA
No Infection		Positive	0	0	0	0	NA
No Infection		Negative	2	1	0	1	50%(1/2), 95% CI:9.5-90.5%
No Infection		No consensus	0	0	0	0	NA
Indeterminate		Positive	31	30	0	1	93.8%(30/32), 95% CI:79.9-98.3%

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Image /page/10/Picture/1 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 shape is positioned to the left of the word "FOCUS", creating a visual element that complements the text.

510(k) Summary of Safety and Effectiveness Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M Prepared Date: July 22, 2008 Page 11 of 13

		Table 9: EBV VCA IgM Results
Serological Status by
Predicates	Consensus Predicate	n	Positive	Equivocal	Negative	% Agreement
Indeterminate	Negative	2	2	0	0	0%(0/2), 95% CI:0-65.8%
Indeterminate	No consensus1	1	0	0	1	NA

4 No consensus results: the contination of three predicates could not yield a conclusive result for these samples - a 2/3 majority could not be obtained.

Presumed Acute Retrospective Samples Plexus EBV vs. Heterophile Rapid Test for Heterophile IgM analyte (by Serological Status)

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 Heterophile IgM analyte when the Heterophile rapid test is used as predicate for Heterophile IgM analysis and consensus predicate is used for VCA IgM analysis.

					Table 10: EBV Heterophile IgM Results
		Predicate Heterophile
Rapid Test			Plexus
Serological Status by
Predicates			n	Positive	Equivocal	Negative	% Agreement
Acute	Primary
Acute	Positive	87	75	2	10	86.2%(75/87), 95% CI:77.4-91.9%
		Negative	19	2	0	17	89.5%(17/19), 95% CI:68.6-97.1%
Acute	Late
Acute	Positive	3	2	0	1	66.7%(2/3), 95% CI:20.8-93.9%
		Negative	5	0	0	5	100%(5/5), 95% CI:56.6-100%
	No Infection	Positive	0	0	0	0	NA
No Infection		Negative	2	0	0	2	100%(2/2), 95% CI:34.2-100%
Indeterminate		Positive	22	21	1	0	95.5%(21/22), 95% CI:78.2-99.2%
	Indeterminate	Negative	12	1	0	11	91.7%(11/12), 95% CI:64.6-98.5%

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

The interfintra-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 results of the study are summarized in the table below.

	Table 11: Inter-laboratory, Intra-assay and Inter-assay Reproducibility
Plexus VCA IgM						Plexus Heterophile Antibody
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
6	4.48	2.2%	13.7%	4.48	8.8%	6	6.12	3.0%	16.7%	6.12	14.1%
5	2.67	4.2%	15.0%	2.67	10.0%	2	4.46	3.8%	15.8%	4.46	10.2%
2	2.08	2.4%	18.7%	2.08	16.3%	4	2.19	5.0%	13.8%	2.19	1.9%
4	1.24	3.6%	13.2%	1.24	6.7%	3	1.20	6.1%	15.8%	1.20	5.2%
12	1.12	4.4%	25.3%	1.12	9.0%	13	0.74	6.4%	14.0%	0.74	7.2%
8	0.98	5.2%	22.1%	0.98	16.0%	8	0.55	5.7%	12.8%	0.55	3.3%
3	0.77	6.1%	28.2%	0.77	24.3%	5	0.27	8.3%	47.2%	0.27	47.8%
13	0.59	6.1%	46.8%	0.59	51.8%	11	0.14	5.6%	20.2%	0.14	3.8%

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Image /page/11/Picture/1 description: The image shows the logo for Focus Diagnostics. The logo features the word "FOCUS" in bold, sans-serif font, with a curved, swooping shape to the left of the word. Below the word "FOCUS" is a horizontal line, and below that line is the word "Diagnostics" in a smaller, sans-serif font.

510(k) Summary of Safety and Effectiveness Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M

Prepared Date: July 22, 2008

Page 12 of 13

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Inter-Lot Reproducibility

The inter-lot reproducibility was evaluated with eleven (11) samples in triplicates on three (3) lots of Plexus EBV kit. The results of the study are summarized in the table below.

Table 12: Inter-lot Reproducibility
	Plexus VCA IgM			Plexus Heterophile Antibody
ID	Mean Index	%CV	ID	Mean Index	%CV
6	4.64	5.2%	6	5.65	3.8%
5	2.83	7.6%	2	4.42	4.5%
2	2.09	6.0%	4	2.05	4.3%
4	1.13	5.0%	3	1.12	5.6%
8	0.87	16.9%	13	0.78	7.2%
12	0.84	17.5%	8	0.54	10.6%
3	0.71	17.1%	5	0.44	37.9%
13	0.60	24.4%	11	0.13	8.4%
7	0.05	19.4%	7	0.04	14.8%
11	0.05	16.0%	12	0.04	20.4%
1	0.04	19.3%	1	0.03	18.8%

Cross-Reactivity

A cross-reactivity study was performed to determine if samples disease states and other potentially cross-reactivity factors interfere with test results when tested with the Plexus EBV IgM kit. A panel of (Antinuclear Antibody test (ANA) n=28, Cytomegalovirus (CMV) n=25, Herpes Simplex Virus-1 (HSV-1) and Herpes Simplex Virus-2 (HSV-2) n =2, Rheumatoid Factor (Rh) n=29, Rubella Virus n=5, and Varicella-Zoster Virus (VZV) n=42). samples for each cross reactant were evaluated for possible cross reactivity with the Plexus EBV IgM kit for each of the two (VCA and Heterophile) IgM analyte. The test samples were also evaluated on commercially available ELISA and heterophile rapid test. The majority of all samples that elicit a negative result were also confirmed negative by the corresponding commercially available tests, showing that the Plexus EBV IgM kit did not have additional cross-reactivity

Table 13: Cross-Reactivity
Cross Reactives	N	Method	EBV VCA IgM			EBV Heterophile
			Positive	Equivocal	Negative	Positive	Equivocal	Negative
ANA	28	Plexus	0	2	26	0	0	28
		ELISA	0	0	28	0	0	28
		Discrepants	22			0
Cytomegalovirus
(CMV)	25	Plexus4	2	1	21	0	0	24
		ELISA	1	0	24	0	0	25
		Discrepants	51			14
HSV 1 & HSV 2	2	Plexus	0	0	2	0	0	2
		ELISA	0	0	2	0	0	2
		Discrepants	0			0
Rheumatoid Factor
(Rh)	29	Plexus	4	0	25	0	0	29
	29	ELISA	0	0	29	0	0	29

12

Image /page/12/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, swooping line is positioned to the left of the word "FOCUS", adding a dynamic element to the design.

510(k) Summary of Safety and Effectiveness Plexus EBV IgM Multi-Analyte Diagnostics Catalog No. MP0600M Prepared Date: July 22, 2008 Page 13 of 13

		Discrepants	4		0
Rubella	5	Plexus	0	0	5	0	0	5
		ELISA	0	0	5	0	0	5
		Discrepants	0			0
Varicella-zoster
(VZV)	42	Plexus	2	1	39	2	0	40
		ELISA	1	2	39	2	0	40
		Discrepants	33			0

1 One Equivocal Sample; 2 Two Equivocal Samples; "Three Equivocal Samples; 4 One Invalid Sample

Sample Storage and Handling

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

Interference

The test performance was evaluated with the presence of interfering substances. Four samples, two positive and two negative for EBV VCA IgM and heterophile antibody by Plexus EBV IgM were used in the study. Baseline ERV IgM levels were established for each sample before interferents were added. Two concentration levels of each interferent were used: triglycerides (1 mg/mL), albumin (6 mg/mL and 60 mg/mL), bilirubin (0.02 mg/mL and 0.2 mg/mL), and hemoglobin (22 mg/mL) The higher interferent concentrations represent levels that exceed the expected human range. All samples were evaluated to determine if these interfering substances affect the assay. No interference was observed for any of the substances in either the positive or negative sample.

13

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG - 4 2008

Focus Diagnostics, Inc. C/O Deborah Morris 10703 Progress Way Cypress, California 90630

Re: K073381

Trade/Device Name: Plexus EBV IgM Multi-Analyte Diagnostics Regulation Number: 21 CFR 866.3235 Regulation Name: Epstein-Barr Virus Serological Reagents Regulatory Class: Class I Product Code: LJN Dated: November 30, 2007 Received: December 3, 2007

Dear Ms. Morris:

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket

14

Page 2 - Focus Diagnostics, Inc.

notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Salez a Agre

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

15

510(k) Number (if known):

K073381

Device Name:

Plexus EBV IgM Multi-Analyte Diagnostics

Indications for Use:

Focus Diagnostics' Plexus™ EBV IgM Multi-Analyte Diagnostics test kit is intended for qualitatively detecting the presence or absence of human IgM class antibodies to viral capsid antigen (VCA), and heterophile antibodies 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)

the Schf
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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