The DiaSorin LIAISON® VZV IgG uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer family for the qualitative detection of specific IgG antibodies to varicella-zoster virus (VZV) in human serum. This assay can be used as an aid in the determination of previous infection of varicella-zoster virus. The assay performance in detecting antibodies to VZV in individuals vaccinated with the FDA-licensed VZV vaccine is unknown. The user of this assay is responsible for establishing the performance characteristics with VZV vaccinated individuals.

The DiaSorin LIAISON® Control VZV IgG (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the DiaSorin LIAISON® VZV IgG assay on the LIAISON® Analyzer family. The performance characteristics of the LIAISON® Control VZV IgG have not been established for any other assay or instrument platforms different from LIAISON® and LIAISON® XL.

Device Description

The LIAISON® VZV IgG is an indirect chemiluminescence immunoassay (CLIA) for qualitative determination of specific IgG antibodies to varicella-zoster virus in human serum.

The LIAISON® Control VZV IqG are liquid ready-to-use controls based 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 assay and controls are designed for use with DiaSorin LIAISON® Analyzer familv.

AI/ML Overview

This document describes modifications to the LIAISON® VZV IgG assay and LIAISON® Control VZV IgG, and provides a summary of performance data to support the substantial equivalence to the predicate device.

Here's the breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with reported numerical performance values against them. Instead, it states that "Non-clinical verification and validation testing conducted with the LIAISON® VZV IgG and LIAISON® Control VZV IgG demonstrate that the modified devices met predetermined acceptance criteria".

The types of claims supported by testing are listed:

Acceptance Criteria (Implied by claims)	Reported Device Performance (Implied by meeting criteria)
LIAISON® VZV IgG:
8 weeks On-Board/Open Use Stability	Met predetermined acceptance criteria
8 weeks Stability of Calibration	Met predetermined acceptance criteria
7 Days Refrigerated (2-8°C) Serum Storage	Met predetermined acceptance criteria
5 Freeze-Thaw Cycles Serum Storage	Met predetermined acceptance criteria (no significant differences reported)
LIAISON® Control VZV IgG:
Commutability between Samples and Controls (Matrix Effect)	Met predetermined acceptance criteria
Precision Equivalence between Samples and Controls (20 Day & 5 Day Precision)	Met predetermined acceptance criteria
Control Value Assignment	Met predetermined acceptance criteria
Control Range Definition	Met predetermined acceptance criteria
18 months Shelf-life (2-8°C)	Met predetermined acceptance criteria
8 weeks On-Board/Open Use Stability	Met predetermined acceptance criteria

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

LIAISON® VZV IgG Serum Storage Freeze-Thaw Cycles: "Twelve samples with different reactivity underwent five (5) freeze-thaw cycles."
Other tests: The exact sample sizes for other tests (stability, commutability, precision, control value assignment, control range definition) are not explicitly stated in this summary.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only states "Non-clinical verification and validation testing conducted...".

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The LIAISON® VZV IgG is a chemiluminescence immunoassay (CLIA) for detecting specific IgG antibodies to VZV in human serum. Its performance relies on the assay's chemical and biological properties, not on human interpretation by experts in the context of this specific regulatory submission for modifications. The "ground truth" for VZV IgG assays is typically established through reference methods or well-characterized clinical samples, not by expert readers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and therefore not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, such as imaging studies where multiple readers might interpret images. This device is an in-vitro diagnostic assay.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and therefore not provided in the document. The LIAISON® VZV IgG is an automated in-vitro diagnostic assay and does not involve human readers or AI assistance in its direct operation or interpretation for a comparative effectiveness study as described.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The device itself (LIAISON® VZV IgG) is an automated standalone assay for qualitative detection of VZV IgG antibodies. The performance data presented (stability, precision, etc.) are inherent to the device's operational characteristics without human intervention influencing the assay's result generation. This aligns with the concept of "standalone performance" for an IVD device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly state the specific "ground truth" method used for the initial assays or for validating the modified claims. For an immunoassay like this, the ground truth would typically be established by:

Reference methods: Comparison to a gold standard VZV IgG assay.
Well-characterized clinical samples: Samples from individuals with confirmed VZV infection history or vaccination status, or known serological status.

The purpose of this submission is to demonstrate equivalence of modifications to a previously cleared device, not to re-establish the fundamental clinical validity against a primary ground truth.

8. The sample size for the training set

This information is not applicable and therefore not provided in the document. This is a traditional immunoassay, not a machine learning or AI-based device that would require a distinct "training set." The development of such assays involves reagent formulation, optimization, and extensive verification and validation studies.

9. How the ground truth for the training set was established

This information is not applicable and therefore not provided in the document, as there is no "training set" in the context of this traditional immunoassay.

Summary

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

March 11, 2015

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

Re: K150375

Trade/Device Name: LIAISON® VZV IgG and LIAISON® Control VZV IgG Regulation Number: 21 CFR 866.3900 Regulation Name: Varicella-zoster virus serological reagents Regulatory Class: Class II Product Code: LFY, JJX Dated: February 12, 2015 Received: February 13, 2015

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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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,

Stephen J. Lovell -S for

Sally Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150375

Device Name LIAISON® VZV IgG LIAISON® Control VZV IgG

Indications for Use (Describe)

The DiaSorin LIAISON® Control VZV IgG (negative) is intended for use as assayed quality control samples to monitor the performance of the DiaSorin LIAISON® VZV IgG assay on the LIAISON® Analyzer family. The performance characteristics of the LIAISON® Control VZV IgG have not been established for any other assays or instrument platforms different from LIAISON® and LIAISON® XL.

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

☑ Prescription Use (Part 21 CER 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY

SUBMITTED BY:

Sandra Zimniewicz Requlatory Affairs Specialist DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 Email: sandra.zimniewicz@diasorin.com

DATE PREPARED:

February 12, 2015

NAME OF DEVICE:

Trade Name:

LIAISON® VZV IgG LIAISON® Control VZV IgG

Common Names/Description: VZV IgG Assay and VZV IgG Controls

Classification:

Varicella-zoster virus Serological Reagents: 21 CFR 866.3900; Class III (performance standards); Microbiology (83)

Product Code:

LFY, JJX

LIAISON® VZV IgG (K061820) PREDICATE DEVICE:

DEVICE DESCRIPTION:

The LIAISON® VZV IgG is an indirect chemiluminescence immunoassay (CLIA) for qualitative determination of specific IgG antibodies to varicella-zoster virus in human serum.

The assay and controls are designed for use with DiaSorin LIAISON® Analyzer familv.

INTENDED USE:

The DiaSorin LIAISON® VZV IgG uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer family for the qualitative detection of specific IgG

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antibodies to varicella-zoster (VZV) in human serum. This assay can be used as an aid in the determination of previous infection of varicella-zoster virus.

The assay performance in detecting antibodies to VZV in individuals vaccinated with the FDA-licensed VZV vaccine is unknown. The user of this assay is responsible for establishing the performance characteristics with VZV vaccinated individuals.

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

Modifications to the DiaSorin LIAISON® VZV IgG assay include an increase in the number of tests provided per kit, extension of on board/open use and calibration stability, the addition of serum specimen stability claim for 5 freeze-thaw cycles and the extension of refrigerated storage (2-8ºC) for serum specimens from two (2) days to seven (7) days.

Changes to the DiaSorin LIAISON® Control VZV IgG 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® VZV IgG, LIAISON® Control VZV IgG and the modified devices.

Table of Similarities LIAISON® VZV IgG
Characteristic	Predicate Device DiaSorinLIAISON® VZV IgG K061820,cleared 02/26/2007	Modified DeviceDiaSorin LIAISON® VZV IgG
IntendedUse/Indications forUse	The DiaSorin LIAISON® VZV IgG useschemiluminescence immunoassay (CLIA)technology on the LIAISON® Analyzer family for thequalitative detection of specific IgG antibodies tovaricella-zoster virus (VZV) in human serum. Thisassay can be used as an aid in the determinationof previous infection of varicella-zoster virus.The assay performance in detecting antibodies toVZV in individuals vaccinated with the FDAlicensed VZV vaccine is unknown. The user of thisassay is responsible for establishing theperformance characteristics with VZV vaccinatedindividuals.	Same
Technology/Assay Principle	Chemiluminescent Immunoassay (CLIA)	Same
SampleHandling/AssayProcessing	Automated	Same

Reagent IntegralConfiguration(1 compartmenteach reagent)	• Magnetic particles• Calibrator 1• Calibrator 2• Specimen Diluent• Conjugate	Same
Raw materials	No Change• Antigen: Inactivated varicella-zoster viruslysate (ROD strain)• Detector: Mouse monoclonal anti-humanIgG conjugated to isoluminol derivative• Capture: Magnetic microparticles coatedwith varicella-zoster antigen	Same
ReagentFormulation	No Change	Same
ManufacturingProcess	No Change	Same
Storage	Store at 2-8°C until ready to use	Same
Measured Analyte	IgG antibodies to Varicella-zoster virus	Same
Sample Type	Human Serum	Same
Sample Volume	20 uL	Same
Assay Procedure	• Dispense calibrators, controls, or samples• Dispense magnetic particles• Dispense specimen diluent• Incubate• Wash• Dispense conjugate• Incubate• Wash• Dispense starter reagent• Measure Light emitted (RLUs)	Same
Total IncubationTime	21 minutes	Same
MeasurementSystem	Photomultiplier (flash chemiluminescence reader)	Same
Calibration	Two point verification of stored master curve	Same
Unit of Measure	Index Value	Same
Cut-Off	150 Index Value	Same
Equivocal Zone	135 - 165 Index Value	Same
Calibrators	Included with kit	Same
Assay PerformanceCharacteristics	No Change	Same
Controls	Provided Separately	Same
Table of Differences LIAISON® VZV IgG
Characteristic	Predicate Device DiaSorinLIAISON® VZV IgG K061820,cleared 02/26/2007	Modified DeviceDiaSorin LIAISON® VZV IgG
Tests per Kit	50	100
Reagent VolumeProvided	Magnetic particles (1.3ml)Conjugate (13ml)	Magnetic particles (2.5 ml)Conjugate (23ml)
Open Use/OnBoard Stability	Four (4) weeks at 2-8°C or on board theanalyzer	Eight (8) weeks at 2-8°C or onboardthe analyzer
Calibration Stability	Fourteen (14) days	Eight (8) weeks
Serum Storage at2-8°C	Two (2) days	Seven (7) days
Serum StorageFreeze-ThawCycles	Samples should not be repeatedly frozenand thawed.	Twelve samples with different reactivityunderwent five (5) freeze-thaw cycles.The results showed no significantdifferences.

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Summary of Similarities and Differences LIAISON® Control VZV IgG
Characteristic	Predicate DeviceDiaSorin LIAISON® Control VZV IgGK061820, cleared 02/26/2007	Modified DeviceDiaSorin LIAISON® Control VZV IgG
Intended Use	The LIAISON® VZV IgG controls(negative, positive controls) are used formonitoring substantial reagent failure ofthe LIAISON® VZV IgG chemiluminescentimmunoassay (CLIA). The LIAISON® VZVIgG quality control material contains a 5%serum matrix and may not adequatelycontrol the DiaSorin LIAISON® VZV IgGassay for serum specimens. Theperformance of the LIAISON® VZV IgGcontrols has not been established withany other VZV assay or instrumentplatforms different from LIAISON® andLIAISON® XL.	The DiaSorin LIAISON® Control VZVIgG (negative and positive) is intendedfor use as assayed quality controlsamples to monitor the performance ofthe DiaSorin LIAISON® VZV IgG assayon the LIAISON® Analyzer family. Theperformance characteristics of theLIAISON® VZV Control IgG have notbeen established for any other assayor instrument platforms different fromLIAISON® and LIAISON® XL.
Negative Control	5% Human Serum/plasma non-reactivefor VZV IgG antibodies, stabilized inTRIS-NaCl buffer, preservatives.	Human Serum/plasma non-reactive forVZV IgG antibodies, 0.2% ProClin.
Positive Control	5% Human Serum/plasma reactive forVZV IgG antibodies, stabilized in TRIS-NaCl buffer, preservatives, inert yellowdye.	Human Serum/plasma reactive forVZV IgG antibodies, 0.2% ProClin.
ReagentConfiguration	2 vials each level (negative and positive)0.7 mL/vial, ready to use.	Same
Storage	Store at 2-8°C until ready to use	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.

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SUMMARY OF PERFORMANCE DATA:

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

Real Time Stability testing conducted on the LIAISON® VZV IgG to support the following product claims:

. Eight (8) weeks On-Board/Open Use Stability
Eight (8) weeks Stability of Calibration ●

Real time stability testing on human serum specimens to support storage claims:

Seven (7) Days Refrigerated (2-8°C)
Five (5) Freeze-Thaw Cycles .

Testing of the LIAISON® Control VZV IgG to validate and verify:

Commutability between Samples and Controls (Matrix Effect) .
Precison Equivalence between Samples and Controls
- o 20 Day Precison
- o 5 Day Precision
Control Value Assignment ●
Control Range Definition ●

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

Shelf-life of 18 months at (2-8°C) .
Eight (8) weeks On-Board/Open Use Stability .

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

CONCLUSION:

As summarized, the DiaSorin LIAISON® VZV IgG and LIAISON® Control VZV IgG, are substantially equivalent to the originally cleared devices. 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

§ 866.3900 Varicella-zoster virus serological reagents.

(a)
Identification. Varicella-zoster virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to varicella-zoster in serum. The identification aids in the diagnosis of diseases caused by varicella-zoster viruses and provides epidemiological information on these diseases. Varicella (chicken pox) is a mild, highly infectious disease, chiefly of children. Zoster (shingles) is the recurrent form of the disease, occurring in adults who were previously infected with varicella-zoster viruses. Zoster is the response (characterized by a rash) of the partially immune host to a reactivation of varicella viruses present in latent form in the patient's body.(b)
Classification. Class II (performance standards).