K Number

Device Name

LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set

Manufacturer

DIASORIN INC.

Date Cleared

2017-01-04

(72 days)

Product Code

LSE JJX

Regulation Number

866.3235

Intended Use

The LIAISON® EA 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) early antigen-diffuse [EA(D)] in human serum. This assay uses a 47-kDa recombinant antigen expressed in E. coli DH-1 cells. 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 infectious mononucleosis. The DiaSorin LIAISON® EA IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® EA IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® EA 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® EA IgG is an indirect chemiluminescence immunassay (CLIA) technology on the LIAISON Analyzer family* for the qualitative determination of IgG antibodies to Epstine-Barr virus (EBV) early antigen-diffuse [ea(D)] in human serum. The LIAISON® EA IgG Serum Control Set (negative and positive) consists of liquid ready-to-use 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® EA IgG assay on the LIAISON® Analyzer family.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K060204

Reference Devices

K060204

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard chemiluminescent immunoassay (CLIA) for detecting antibodies. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the chemical reaction and the analyzer's ability to measure the resulting luminescence.

Therapeutic

No.
The device is an in-vitro diagnostic assay used to detect antibodies for diagnostic purposes, not to treat a disease.

Diagnostic

Yes
The device is described as an "aid in the clinical laboratory diagnosis of Epstein-Barr Viral Syndrome," indicating its role in identifying a medical condition.

SaMD (Software as a Medical Device)

The device description explicitly mentions "chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family" and "liquid ready-to-use controls in human serum/defibrinated plasma," indicating the device includes physical components (reagents, controls) and relies on a hardware analyzer, not just software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The primary intended use is the "qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) early antigen-diffuse [EA(D)] in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information for diagnosis.
Aid in Diagnosis: The intended use explicitly states it can be used as an "aid in the clinical laboratory diagnosis of Epstein-Barr Viral Syndrome." This is a key characteristic of IVDs.
Device Description: The device description further clarifies that it is an "indirect chemiluminescence immunassay (CLIA) technology... for the qualitative determination of IgG antibodies... in human serum." This reinforces the in vitro testing of a human sample.
Control Set: The associated control set is also described as being used to "monitor the performance of the LIAISON® EA IgG assay," which is a standard practice for ensuring the reliability of IVD tests.

The information provided clearly aligns with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

*(LIAISON® and LIAISON® XL)

Product codes

LSE, JJX

Device Description

The LIAISON® EA IgG Serum Control Set (negative and positive) consists of liquid ready-to-use 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® EA IgG assay on the LIAISON® Analyzer family.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human serum

Indicated Patient Age Range

Not Found

Intended User / Care Setting

clinical laboratory

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

Not Found

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

Non-clinical verification and validation testing conducted with the LIAISON® EA IgG and LIAISON® EA 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® EA IgG Serum Control Set to validate and verify:

Commutability between samples and controls (matrix effect)
Precison equivalence between samples and controls
- 20 Day Precison
Control value assignment
Control range definition

Real Time Stability testing conducted on the LIAISON® EA 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® EA IgG Serum Control Set do not introduce any new risks to the performance of the device.

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

Not Found

Predicate Device(s)

K060204

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid on three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

January 04, 2017

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

Re: K162959

Trade/Device Name: LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set Regulation Number: 21 CFR 866.3235 Regulation Name: Epstein-Barr virus serological reagents Regulatory Class: Class I Product Code: LSE, JJX Dated: October 21, 2016 Received: December 5, 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 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, Kristian M. Roth -S 2017.01.04 10:57:01 -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

Indications for Use

510(k) Number (if known) K162959

Device Name LIAISON® EA IgG LIAISON® EA IgG Serum Control Set

Indications for Use (Describe)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

*(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:

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DiaSorin LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set Special 510(k): Device Modification

510(k) SUMMARY

| SUBMITTED BY: | DiaSorin Inc.
1951 Northwestern Avenue
P.O. Box 285
Stillwater, MN 55082-0285 |
|---------------------------|------------------------------------------------------------------------------------------|
| CONTACT: | Sunita Teekasingh
Regulatory Affairs Manager
Email: sunita.teekasingh@diasorin.com |
| DATE OF PREPARATION: | October 21, 2016 |
| NAME OF DEVICE: | |
| Trade Name: | LIAISON® EA IgG
LIAISON® EA IgG Serum Control Set |
| Common Names/Description: | Immunoassay for the detection of IgG antibodies to
EBV early antigen-diffuse [EA(D)] |
| Classification: | Epstein-Barr virus serological reagents, 21 CFR
866.3235; Class I, Microbiology (83) |
| Product Code: | LSE, JJX |
| PREDICATE DEVICE: | DiaSorin LIAISON® EA IgG (K060204) |

DEVICE DESCRIPTION:

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

INTENDED USE:

The LIAISON EA 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) early antigen-diffuse [EA(D)] in human serum. This assay uses a 47-kDa recombinant antigen expressed in E. coli DH-1 cells. 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 infectiousmononucleosis.

LIAISON®EA IgG Serum Control Set:

*(LIAISON® and LIAISON® XL)

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

The following tables provide a summary of the FDA cleared LIAISON® EA IgG assay.

LIAISON® EA IgG assay
Characteristic	Predicate Device
DiaSorin LIAISON® EA IgG
K060204, Cleared 10/18/2006	DiaSorin LIAISON® EA IgG
Intended
Use/Indications for
Use	The LIAISON® EA 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) early antigen-diffuse [EA(D)]
in human serum. This assay uses a 47-
kDa recombinant antigen expressed in E.
Coli DH-1 cells. 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.
*(LIAISON® and LIAISON® XL)	No Change
Technology/
Assay Principle	Chemiluminescent Immunoassay (CLIA)	No Change
Sample
Handling/Assay
Processing	Automated	No Change
Storage	Store at 2-8° C until ready to use	No Change
Measured Analyte	IgG antibodies to Epstein-Barr virus (EBV)
early antigen-diffuse [EA(D)].	No Change
Assay Performance
Characteristics	No Change	No Change
Labeling (IFU)	References buffer based controls	References serum based
controls
Controls	Provided Separately	No Change

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

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

Summary of Similarities and Differences LIAISON® EA IgG Serum Control Set
Characteristic	Predicate Device
DiaSorin LIAISON® Control EA IgG
K060204, Cleared 10/18/2006	Modified Device
DiaSorin LIAISON® EA IgG Serum
Control Set
Intended Use	The LIAISON® EA IgG Controls
(negative, positive) are used for
monitoring substantial reagent failure
of the LIAISON® EA IgG
chemiluminescent immunoassay
(CLIA). The LIAISON® EA IgG
quality control material contains only
a 5% serum matrix and may not
adequately control the DiaSorin
LIAISON® EA IgG assay for serum
specimens. The performance of the
LIAISON® EA IgG Controls has not
been established with any other EA
assay or instrument platforms
different from LIAISON® and
LIAISON® XL.	The DiaSorin LIAISON® EA IgG
Serum Control Set is intended for
use as assayed quality control
samples to monitor the performance
of the LIAISON® EA IgG assay on
the LIAISON® Analyzer family*. The
performance characteristics of the
LIAISON® EA IgG controls have not
been established for any other assay
or instrument platforms different from
the LIAISON® and LIAISON® XL.
*(LIAISON® and LIAISON® XL)
Negative Control	5% Human serum/defibrinated
plasma not reactive for EA IgG
antibodies, diluted in PBS buffer,
BSA, with ProClin® 300 as a
preservative.	Human serum/defibrinated plasma
non-reactive for EA IgG antibodies,
0.1% ProClin® 300 and 0.09%
sodium azide.
Positive Control	5% Human serum/defibrinated
plasma reactive for EA IgG
antibodies, diluted in PBS buffer,
BSA, with ProClin® 300 as a
preservative and an inert yellow dye.	Human serum/defibrinated plasma
reactive for EA IgG antibodies, 0.1%
ProClin® 300 and 0.09% sodium
azide.
Reagent
Configuration	2 vials each level (negative and
positive) 0.7 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°C between uses.	Once opened controls are stable for
eight (8) weeks when properly stored
at 2-8°C between uses.

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

SUMMARY OF PERFORMANCE DATA:

Testing of the LIAISON® EA 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® EA 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® EA IgG Serum Control Set do not introduce any new risks to the performance of the device.

CONCLUSION:

As summarized, the LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set is substantially equivalent to the originally cleared device. 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.