The LIAISON® CMV IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of IgG antibodies to human cytomegalovirus (hCMV) in human serum. It is intended to be used as an aid in the determination of serological status to CMV.

The DiaSorin LIAISON® CMV IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® CMV IgG assay on the LIAISON® Analyzer family *. The performance characteristics of the LIAISON® CMV 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® CMV 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® CMV IgG assay on the LIAISON® Analyzer family.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria or specific numerical reported device performance values for the LIAISON® CMV IgG assay (which remains unchanged from the predicate device). However, it focuses on the performance of the LIAISON® CMV IgG Serum Control Set. The acceptance criteria for the controls are described qualitatively:

Acceptance Criteria Category	Specific Criteria (from text)	Reported Device Performance (from text)
LIAISON® CMV IgG Serum Control Set
Commutability	Commutability between samples and controls (matrix effect)	Meets predetermined acceptance criteria, supporting equivalency.
Precision Equivalence	Precision equivalence between samples and controls	Meets predetermined acceptance criteria, supporting equivalency.
20-Day Precision	(Implicit: acceptable precision over 20 days)	Meets predetermined acceptance criteria, supporting equivalency.
Control Value Assignment	(Implicit: accurate assignment of control values)	Meets predetermined acceptance criteria, supporting equivalency.
Control Range Definition	(Implicit: appropriate definition of control ranges)	Meets predetermined acceptance criteria, supporting equivalency.
Shelf-Life Stability	Shelf-life of 12 months at (2-8°C)	Real-time stability testing supports this claim.
Open Use Stability	Eight (8) weeks open use stability when stored at 2-8°C between uses	Real-time stability testing supports this claim.

2. Sample Size and Data Provenance

Test Set Sample Size: The document does not specify the exact sample sizes used for the "Test Set" in the context of commutability, precision, control value assignment, or control range definition. It mentions "samples and controls" for precision equivalence. For stability testing, it states "Real time stability testing," implying a duration-based study rather than a fixed sample count of individual specimens.
Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be internal to the manufacturer (DiaSorin Inc.). The document implies these are non-clinical verification and validation studies. It does not clarify if the data is retrospective or prospective, but real-time stability testing would be prospective.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the document. The device is an immunoassay for detecting antibodies, which typically relies on laboratory-defined cut-offs and established reference methods for "ground truth", rather than expert interpretation of images or clinical cases.

4. Adjudication Method for the Test Set

This information is not provided as it's not relevant for an immunoassay that doesn't involve subjective interpretation or a panel of experts.

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

A MRMC comparative effectiveness study was not done, as this type of study is relevant for imaging devices or algorithms that involve human interpretation and reader variability. The LIAISON® CMV IgG is an automated immunoassay.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The LIAISON® CMV IgG assay is a standalone algorithm/device for its performance. It measures IgG antibodies to hCMV in human serum automatically. The controls are also designed to monitor this automated performance. The study described focuses on the performance characteristics of the controls and their impact on the assay itself, rather than comparing its performance with or without human intervention for result interpretation.

7. Type of Ground Truth Used

The ground truth for immunoassay performance is typically established by:

Reference methods/panels (e.g., CDC reference panels).
Clinically characterized samples (e.g., samples from known CMV-positive and CMV-negative individuals).
Comparison to a legally marketed predicate device (as in this 510(k), where the assay's performance is stated as "No Change" from the cleared predicate, K040290).

The document states that the studies demonstrate the modified device (Control Set) meets "predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device." This strongly implies the ground truth for establishing acceptance and equivalency relies on the established performance characteristics and values of the predicate device and/or defined laboratory standards.

8. Sample Size for the Training Set

The document does not specify a training set sample size, as this filing is for a modification to an already cleared device (the control set for an existing assay). The primary focus is on validating the new control set, not on developing or training a new algorithm from scratch.

9. How the Ground Truth for the Training Set Was Established

As no training set is explicitly mentioned for a new algorithm development, this information is not applicable in the context of this 510(k) submission for a control set modification. For the original assay (K040290), ground truth would have been established using methods mentioned in point 7.

Summary

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

January 6, 2017

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

Re: K162969

Trade/Device Name: LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set Regulation Number: 21 CFR 866.3175 Regulation Name: Cytomegalovirus serological reagents Regulatory Class: Class II Product Code: LFZ, JJX Dated: October 21, 2016 Received: December 8, 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

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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,

Stephen J. Lovell -S 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) K162969

Device Name LIAISON® CMV IgG LIAISON® CMV 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.

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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 .

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

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® CMV IgGLIAISON® CMV IgG Serum Control Set
Common Names/Description:	Immunoassay for the detection of IgG antibodies tohuman Cytomegalovirus (hCMV)
Classification:	Cytomegalovirus serological reagents, 21 CF866.3175 Class II (performance standards)Micorobiology (83)
Product Code:	LFZ, JJX
PREDICATE DEVICE:	DiaSorin LIAISON® CMV IgG (K040290)

DEVICE DESCRIPTION:

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

INTENDED USE:

The LIAISON® CMV IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of IgG antibodies to human cytomeqalovirus (hCMV) in human serum. It is intended to be used as an aid in the determination of serological status to CMV.

The DiaSorin LIAISON® CMV IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® CMV IgG assay on the LIAISON®

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Analyzer family*. The performance characteristics of the LIAISON® CMV IgG controls have not 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® CMV IgG assay.

LIAISON® CMV IgG assay
Characteristic	Predicate DeviceDiaSorin LIAISON® CMV IgGK040290, cleared 06/01/2005	LIAISON® CMV IgG
IntendedUse/Indications forUse	The LIAISON® CMV IgG assay useschemiluminescent immunoassay (CLIA)technology on the LIAISON® Analyzer family* forthe qualitative determination of IgG antibodies tohuman cytomegalovirus (hCMV) in human serum.It is intended to be used as an aid in thedetermination of serological status to CMV.*(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 human cytomegalovirus (hCMV)	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® CMV IgG Serum Control Set include a 100% human 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 CMV IgG and the modified device, LIAISON® CMV IgG Serum Control Set.

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Summary of Similarities and Differences LIAISON® CMV IgG Serum Control Set
Characteristic	Predicate DeviceDiaSorin LIAISON® Control CMV IgGK040290, cleared 06/01/2005	Modified DeviceDiaSorin LIAISON® CMV IgG SerumControl Set
Intended Use	The LIAISON® CMV IgG Controls(negative, positive) are used formonitoring substantial reagent failure ofthe LIAISON® CMV IgGchemiluminescent immunoassay (CLIA).The LIAISON® CMV IgG quality controlmaterial contains only a 5% serum matrixand may not adequately control theDiaSorin LIAISON® CMV IgG assay forserum specimens. The performance ofthe LIAISON® CMV IgG Controls has notbeen established with any other CMVassay or instrument platforms differentfrom LIAISON® and LIAISON® XL.	The DiaSorin LIAISON® CMV IgGSerum Control Set is intended for useas assayed quality control samples tomonitor the performance of theLIAISON® CMV IgG assay on theLIAISON® Analyzer family. Theperformance characteristics of theLIAISON® CMV 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/plasma not reactive forCMV IgG antibodies, diluted in PBSbuffer, BSA, with ProClin® 300 as apreservative.	Human serum/plasma non-reactive forCMV IgG antibodies, 0.1% ProClin®300 and 0.09% sodium azide.
Positive Control	5% Human serum/plasma reactive forCMV IgG antibodies, diluted in PBSbuffer, BSA, with ProClin® 300 as apreservative and an inert yellow dye.	Human serum/plasma reactive forCMV IgG antibodies, 0.1% ProClin®300 and 0.09% sodium azide.
ReagentConfiguration	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°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.

SUMMARY OF PERFORMANCE DATA:

Non-clinical verification and validation testing conducted with the LIAISON® CMV IgG and LIAISON® CMV 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® CMV 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 ●

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Real time stability testing conducted on the LIAISON® CMV 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® CMV IgG Serum Control Set do not introduce any new risks to the performance of the device.

CONCLUSION:

As summarized, LIAISON® CMV IgG and LIAISON® CMV 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.

Regulation Number and Section

§ 866.3175 Cytomegalovirus serological reagents.

(a)
Identification. Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.(b)
Classification. Class II (performance standards).