The LIAISON® VCA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) viral capsid antigen (VCA) p18 synthetic peptide in human serum. When performed in conjunction with other EBV markers, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr Viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis.

The DiaSorin LIAISON® VCA IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® VCA IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® VCA IgG controls have not been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL.

*(LIAISON® and LIAISON® XL).

The LIAISON® EBNA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) nuclear antigen synthetic peptide (EBNA-1) in human serum. When performed in conjunction with other EBV markers, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr Viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis.

The DiaSorin LIAISON® EBNA IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® EBNA IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® EBNA IgG controls have not been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL.

*(LIAISON® and LIAISON® XL).

Device Description

The LIAISON® VCA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) viral capsid antigen (VCA) p18 synthetic peptide in human serum.

The LIAISON® VCA IgG Serum Control Set (negative and positive) consists of liquid ready-touse controls in human serum/defibrinated plasma. The negative control is intended to provide an assay response characteristic of negative patient specimens and the positive control is intended to provide an assay response characteristic of positive patient specimens.

The controls are designed for use with DiaSorin LIAISON® VCA IgG assay on the LIAISON® Analyzer family.

The LIAISON® EBNA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) nuclear antigen synthetic peptide (EBNA-1) in human serum.

The LIAISON® EBNA IgG Serum Control Set (negative) consists of liquid ready-touse controls in human serum. The negative control is intended to provide an assay response characteristic of negative patient specimens and the positive control is intended to provide an assay response characteristic of positive patient specimens.

The controls are designed for use with DiaSorin LIAISON® EBNA IgG assay on the LIAISON® Analyzer family.

AI/ML Overview

This document describes two devices, the LIAISON® VCA IgG and LIAISON® EBNA IgG assays and their respective Serum Control Sets. The provided text primarily focuses on the control sets, detailing the modifications made to them and the studies conducted to demonstrate that these modifications do not compromise the performance or safety of the assays.

A. Acceptance Criteria and Reported Device Performance (LIAISON® VCA IgG Serum Control Set & LIAISON® EBNA IgG Serum Control Set)

The acceptance criteria stated for both control sets are related to their ability to function as intended without introducing new risks after modifications. The performance data section describes the types of studies conducted rather than specific numeric acceptance criteria and resulting reported performance values.

However, based on the description of the studies, we can infer the acceptance criteria and a summary of reported performance:

Acceptance Criteria Category	Inferred Acceptance Criteria	Reported Device Performance
Control Set Performance	The modified control sets should demonstrate: 1. Commutability between samples and controls (matrix effect). 2. Precision equivalence between samples and controls. 3. Accurate control value assignment. 4. Appropriate control range definition.	"Non-clinical verification and validation testing... demonstrate that the modified device meets predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device." Specific values are not provided.
Stability (Shelf-life)	The control set should maintain its performance over a 12-month shelf-life when stored at 2-8°C.	Supported a "Shelf-life of 12 months at (2-8°C)".
Stability (Open Use)	The control set should maintain its performance for eight (8) weeks after opening when stored at 2-8°C between uses.	Supported "Eight (8) weeks open use stability when stored at 2-8°C between uses."
Risk Assessment	The modifications should not introduce any new risks to the performance of the device.	"Based on the results from the validation and verification activities, the modifications to the LIAISON® VCA IgG Serum Control Set [and EBNA IgG Serum Control Set] do not introduce any new risks to the performance of the device."

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

The document does not specify the exact sample sizes for the test sets used in the validation and verification studies (e.g., for commutability, precision, value assignment, or stability). It only states that these studies were conducted.

The data provenance is not explicitly mentioned with respect to country of origin, but the controls are described as being made from "Human serum/defibrinated plasma." The studies are retrospective as they validated modifications to an already cleared device.

C. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided. The document describes in-vitro diagnostic devices (immunoassays and control sets), and the ground truth for such devices is typically established through reference methods, certified materials, or clinical samples with confirmed status, rather than expert consensus on interpretation of device output.

D. Adjudication Method

Not applicable for this type of in-vitro diagnostic device validation. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation by human readers.

E. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is an in-vitro diagnostic device, not an imaging or interpretation assistance device for human readers. The studies focus on the analytical performance of the control sets themselves.

F. Standalone Performance

The devices in question are control sets for existing immunoassays. Their performance is inherently tied to the assay they are controlling. The document describes "non-clinical verification and validation testing" demonstrating that the modified control sets meet acceptance criteria, implying an assessment of their analytical performance in a standalone context as control materials. However, "standalone" in the context of an algorithm without human-in-the-loop performance is not relevant here. The "performance characteristics of the LIAISON® VCA IgG controls have not been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL," indicating their intended specific use.

G. Type of Ground Truth Used

The ground truth for the performance of these control sets would be established against the expected performance of the LIAISON® VCA IgG and LIAISON® EBNA IgG assays. This would involve using:

Reference materials: Potentially, certified reference materials or established in-house reference materials to assign values and check accuracy.
Clinical samples: Patient samples with known positive or negative status (likely determined by established reference methods for EBV) would be used to assess commutability and ensure the controls behave similarly to actual patient samples.
Established assay performance: The predicate device's known performance characteristics (precision, accuracy, etc.) would serve as a benchmark for evaluating the equivalency of the modified control sets.

The document implicitly refers to this by stating the studies "demonstrate that the modified device meets predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device."

H. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning, as this is an in-vitro diagnostic device (immunoassay control set). The studies described are validation and verification studies for analytical performance and stability, not a machine learning model.

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

Not applicable, as there is no mention of a machine learning training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

January 05, 2017

DIASORIN INCORPORATED JOHN C. WALTER PRESIDENT 1951 NORTHWESTERN AVE. STILLWATER, MN 55082

Re: K162961

Trade/Device Name: LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set Regulation Number: 21 CFR 866.3235 Regulation Name: Epstein-Barr virus serological reagents Regulatory Class: Class I Product Code: LSE, LLM, JJX Dated: October 21, 2016 Received: December 6, 2016

Dear Mr. Walter:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Maria I. Garcia -S 2017.01.05 10:28:34 -05'00'

For: Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K162961

Device Name

LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set

Indications for Use (Describe)

*(LIAISON® and LIAISON® XL).

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known) K162961

Device Name

LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set

Indications for Use (Describe)

*(LIAISON® and LIAISON® XL).

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) SUMMARY

SUBMITTED BY:	DiaSorin Inc.1951 Northwestern AvenueP.O. Box 285Stillwater, MN 55082-0285
CONTACT:	Gagan GillRegulatory Affairs AssociateEmail: gagan.gill@diasorin.com
DATE OF PREPARATION:	October 21, 2016
NAME OF DEVICE:
Trade Name:	LIAISON® VCA IgGLIAISON® VCA IgG Serum Control Set
Common Names/Description:	Immunoassay for the detection of IgG antibodies toEBV viral capsid antigens (VCA)
Classification:	Epstein-Barr Virus, serological reagents; 21 CFR866.3235; Class I, Microbiology(83)
Product Code:	LSE, JJX
PREDICATE DEVICE:	DiaSorin LIAISON® VCA IgG (K040120)

DEVICE DESCRIPTION:

The controls are designed for use with DiaSorin LIAISON® VCA IgG assay on the LIAISON® Analyzer family.

INTENDED USE:

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been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL.

*(LIAISON® and LIAISON® XL).

COMPARISON TO THE PREDICATE (Description of the Modifications to the Legally Marketed Device):

The following table provides a summary of the FDA cleared LIAISON® VCA IgG assay.

LIAISON® VCA IgG assay
Characteristic	Predicate DeviceDiaSorin LIAISON® VCA IgGK040120, Cleared 06/01/2005	DiaSorin LIAISON® VCA IgG
IntendedUse/Indications forUse	The LIAISON® VCA IgG assay useschemiluminescent immunoassay (CLIA) technologyon the LIAISON® Analyzer family* for the qualitativedetermination of specific IgG antibodies to Epstein-Barr virus (EBV) viral capsid antigen (VCA) p18synthetic peptide in human serum. Whenperformed in conjunction with other EBV markers,this assay can be used as an aid in the clinincallaboratory diagnosis of Epstein-Barr ViralSyndrome in patients with signs and symptoms ofEBV infection such as infectious mononucleosis.*(LIAISON® and LIAISON® XL).	No Change
Technology/Assay Principle	Chemiluminescent Immunoassay (CLIA)	No Change
SampleHandling/AssayProcessing	Automated	No Change
Storage	Store at 2-8° C until ready to use	No Change
Measured Analyte	IgG antibodies to Epstein-Barr virus (EBV) viralcapsid antigen	No Change
Assay PerformanceCharacteristics	No Change	No Change
Labeling (IFU)	References buffer based controls	References serum basedcontrols
Controls	Provided Separately	No Change

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Changes to the DiaSorin LIAISON® VCA IgG Serum Control Set include a 100% serum/defibrinated plasma based matrix and the extension of the open use stability claim.

The following tables provide a summary of the similarities and differences between the FDA cleared LIAISON® Control VCA IgG and the modified device, LIAISON® VCA IgG Serum Control Set.

Summary of Similarities and Differences LIAISON® VCA IgG Control Set
Characteristic	Predicate DeviceDiaSorin LIAISON® Control VCA IgGK040120, Cleared 06/01/2005	Modified DeviceDiaSorin LIAISON® VCA IgG SerumControl Set
Intended Use	The LIAISON® VCA IgG Controls(negative, positive) are used formonitoring substantial reagent failureof the LIAISON® VCA IgGchemiluminescent immunoassay(CLIA). The LIAISON® VCA IgG qualitycontrol material contains a 5% serummatrix and may not adequately controlthe DiaSorin LIAISON® VCA IgG assayfor serum specimens. Theperformance of the LIAISON® VCAIgG Controls has not been establishedwith any other EBV assay orinstrument platforms different fromLIAISON® and LIAISON® XL.	The DiaSorin LIAISON® VCA IgGSerum Control Set is intended for useas assayed quality control samples tomonitor the performance of theLIAISON® VCA IgG assay on theLIAISON® Analyzer family. Theperformance characteristics of theLIAISON® VCA IgG controls have notbeen established for any other assay orinstrument platforms different from theLIAISON® and LIAISON® XL.(LIAISON® and LIAISON® XL).
Negative Control	5% Human serum/defibrinated plasmanot reactive for VCA IgG antibodies,diluted in PBS buffer, BSA, withProClin® 300 as a preservative.	Human serum/defibrinatedplasma non-reactive for VCA IgG antibodies, 0.1%ProClin® 300 and 0.09% sodium azide.
Positive Control	5% Human serum/defibrinated plasmareactive for VCA IgG antibodies, diluted inPBS buffer, BSA, with ProClin® 300 as apreservative and an inert yellow dye.	Human serum/defibrinated plasmareactive for VCA IgG antibodies, 0.1%ProClin® 300 and 0.09% sodium azide.
ReagentConfiguration	2 vials each level (negative and positive)0.9 mL/vial, ready to use.	Same
Storage	Store at 2-8°C	Same
Open UseStability	Once opened controls are stable for four(4) weeks when properly stored at 2-8°Cbetween uses.	Once opened controls are stable foreight (8) weeks when properly stored at2-8°C between uses.

ProClin® is a trademark of the Dow Chemical Company (Dow) or an affiliated company of Dow.

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SUMMARY OF PERFORMANCE DATA:

Non-clinical verification and validation testing conducted with the LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set demonstrate that the modified device meets predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device. Evidence is demonstrated through the following studies:

Testing of the LIAISON® VCA IgG Serum Control Set to validate and verify:

Commutability between samples and controls (matrix effect)
. Precison equivalence between samples and controls
- o 20 day precison
. Control value assignment
Control range definition .

Real Time Stability testing conducted on the LIAISON® VCA IgG Serum Control Set to support the following product claims:

Shelf-life of 12 months at (2-8°C) ●
Eight (8) weeks open use stability when stored at 2-8°C between uses .

Based on the results from the validation and verification activities, the modifications to the LIAISON® VCA IgG Serum Control Set do not introduce any new risks to the performance of the device.

CONCLUSION:

As summarized, LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set is substantially equivalent to the originally cleared device. The changes to the device do not constitute new intended/indications for use, or changes to the fundamental scientific technology. Performance testing of the device demonstrates that the device functions as intended, meeting the requirements of design specifications. The device was determined to be substantially equivalent to the previously cleared device.

The material submitted in this Special 510(k) is complete and supports a substantial equivalence decision. The labeling satisfies the requirements of 21 CFR 809.10.

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510(k) SUMMARY

SUBMITTED BY:	DiaSorin Inc.1951 Northwestern AvenueP.O. Box 285Stillwater, MN 55082-0285
CONTACT:	Gagan GillRegulatory Affairs AssociateEmail: gagan.gill@diasorin.com
DATE OF PREPARATION:	October 21, 2016
NAME OF DEVICE:
Trade Name:	LIAISON® EBNA IgGLIAISON® EBNA IgG Serum Control Set
Common Names/Description:	Immunoassay for the detection of IgG antibodies toEBV Nuclear Antigen (EBNA)
Classification:	Epstein-Barr Virus, serological reagents; 21 CFR866.3235; Class I, Microbiology(83)
Product Code:	LLM, JJX
PREDICATE DEVICE:	DiaSorin LIAISON® EBNA IgG (K040120)

DEVICE DESCRIPTION:

The controls are designed for use with DiaSorin LIAISON® EBNA IgG assay on the LIAISON® Analyzer family.

INTENDED USE:

The LIAISON® EBNA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) nuclear antigen synthetic peptide (EBNA-1) in human serum. When performed in conjunction with other EBV markers, this assay can be used as an aid in the clinincal laboratory diagnosis of Epstein-Barr Viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis.

{9}------------------------------------------------

been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL.

*(LIAISON® and LIAISON® XL)

COMPARISON TO THE PREDICATE (Description of the Modifications to the Legally Marketed Device):

The following table provides a summary of the FDA cleared LIAISON® EBNA IgG assay.

LIAISON® EBNA IgG assay
Characteristic	Predicate DeviceDiaSorin LIAISON® EBNA IgGK040120, cleared 06/01/2005	DiaSorin LIAISON® EBNA IgG
IntendedUse/Indications forUse	The LIAISON® EBNA IgG assay useschemiluminescent immunoassay (CLIA)technology on the LIAISON® Analyzer familyfor the qualitative determination of specificIgG antibodies to Epstein-Barr virus (EBV)nuclear antigen synthetic peptide (EBNA-1) inhuman serum. When performed in conjunctionwith other EBV markers, this assay can beused as an aid in the clinical laboratorydiagnosis of Epstein-Barr Viral Syndrome inpatients with signs and symptoms of EBVinfection such as infectious mononucleosis.(LIAISON® and LIAISON® XL).	No Change
Technology/Assay Principle	Chemiluminescent Immunoassay (CLIA)	No Change
SampleHandling/AssayProcessing	Automated	No Change
Storage	Store at 2-8° C until ready to use	No Change
Measured Analyte	IgG antibodies to Epstein-Barr virus (EBV)nuclear antigen	No Change
Assay PerformanceCharacteristics	No Change	No Change
Labeling (IFU)	References buffer based controls	References serum based controls
Controls	Provided Separately	No Change

Changes to the DiaSorin LIAISON® EBNA IgG Serum Control Set include a 100% serum/defibrinated plasma based matrix and the extension of the open use stability claim.

{10}------------------------------------------------

The following table provides a summary of the similarities and differences between the FDA cleared LIAISON® Control EBNA IgG and the modified device, LIAISON® EBNA IgG Serum Control Set.

Summary of Similarities and Differences LIAISON® EBNA IgG Control Set
Characteristic	Predicate DeviceDiaSorin LIAISON® Control EBNA IgGK040120, cleared 06/01/2005	Modified DeviceDiaSorin LIAISON® EBNA IgG SerumControl Set
Intended Use	The LIAISON® EBNA IgG Serum Controls(negative, positive) are used for monitoringsubstantial reagent failure of the LIAISON®EBNA IgG chemiluminescentimmunoassay (CLIA). The LIAISON®EBNA IgG quality control material containsa 5% serum matrix and may notadequately control the DiaSorin LIAISON®EBNA IgG assay for serum specimens.The performance of the LIAISON® EBNAIgG Controls has not been established withany other EBV assay or instrumentplatforms different from LIAISON® andLIAISON® XL.	The DiaSorin LIAISON® EBNA IgGSerum Control Set is intended for useas assayed quality control samples tomonitor the performance of theLIAISON® EBNA IgG assay on theLIAISON® Analyzer family. Theperformance characteristics of theLIAISON® EBNA IgG controls have notbeen established for any other assayor instrument platforms different fromthe LIAISON® and LIAISON® XL.(LIAISON® and LIAISON® XL).
Negative Control	5% Human serum/ defibrinated plasma notreactive for EBNA IgG antibodies, dilutedin PBS buffer, BSA, with ProClin® 300 asa preservative.	Human serum/defibrinated plasmanon-reactive for EBNA IgG antibodies,0.1% ProClin® 300 and 0.09% sodiumazide.
Positive Control	5% Human serum/defibrinated plasmareactive for EBNA IgG antibodies, dilutedin PBS buffer, BSA, with ProClin® 300 as apreservative and an inert yellow dye.	Human Serum/defibrinated plasmareactive for EBNA IgG antibodies,0.1% ProClin® 300 and 0.09% sodiumazide.
ReagentConfiguration	2 vials each level (negative and positive)0.9 mL/vial, ready to use.	Same
Storage	Store at 2-8°C	Same
Open Use Stability	Once opened controls are stable for four(4) weeks when properly stored at 2-8°Cbetween uses.	Once opened controls are stable foreight (8) weeks when properly storedat 2-8°C between uses.

ProClin® is a trademark of the Dow Chemical Company (Dow) or an affiliated company of Dow.

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SUMMARY OF PERFORMANCE DATA:

Non-clinical verification and validation testing conducted with the LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set demonstrate that the modified device meets predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device. Evidence is demonstrated through the following studies:

Testing of the LIAISON® EBNA IgG Serum Control Set to validate and verify:

. Commutability between samples and controls (Matrix Effect)
. Precison equivalence between samples and controls
- o 20 Day Precison
. Control value assignment
Control range definition .

Real time stability testing conducted on the LIAISON® EBNA IgG Serum Control Set to support the following product claims:

Shelf-life of 12 months at (2-8°C) ●
Eight (8) weeks open use stability when stored at 2-8°C between uses .

Based on the results from the validation and verification activities, the modifications to the LIAISON® EBNA IgG Serum Control Set do not introduce any new risks to the performance of the device.

CONCLUSION:

As summarized, LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set is substantially equivalent to the originally cleared device. The changes to the device do not constitute new intended/indications for use, or changes to the fundamental scientific technology. Performance testing of the device demonstrates that the device functions as intended, meeting the requirements of design specifications. The device was determined to be substantially equivalent to the previously cleared device.

The material submitted in this Special 510(k) is complete and supports a substantial equivalence decision. The labeling satisfies the requirements of 21 CFR 809.10.

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).