The LIAISON® EBV IgM Serum Control Set (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® EBV IgM assay on the LIAISON® Analyzer family.

Device Description

The LIAISON® EBV IgM Serum Control Set (negative and positive) consists of liquid ready-to-use 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® EBV IgM assay on the LIAISON® analyzer family.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device: the LIAISON® EBV IgM Serum Control Set. This document is a regulatory filing, not a research paper detailing a study of an AI/ML powered device. As such, many of the requested details regarding acceptance criteria, study design for AI models, human expert involvement, and specific performance metrics for an AI system are not present or applicable.

The document discusses analytical validation of a quality control material for an immunoassay, not an AI/ML algorithm. The "performance data" sections refer to studies demonstrating the utility and stability of this control material itself, rather than testing the performance of an AI system against clinical ground truth.

Therefore, for aspects related to AI/ML device performance validation, the document does not contain the necessary information. I will, however, extract the information that is present and relevant to the closest interpretation of the prompt for a non-AI device.

Here's what can be extracted and what information is missing:

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

The document mentions "predetermined acceptance criteria" and that the modified device "meets" them, but does not provide a specific table of these criteria or the numerical performance results against them. It lists the types of studies conducted:

Study Type	Reported Performance/Outcome
Commutability (Matrix Effect)	"demonstrate that the modified device meets predetermined acceptance criteria"
Precision Equivalence	"demonstrate that the modified device meets predetermined acceptance criteria"
Control Value Assignment	"demonstrate that the modified device meets predetermined acceptance criteria"
Control Range Definition	"demonstrate that the modified device meets predetermined acceptance criteria"
Real Time Stability (Shelf-life)	Supports claims: "Shelf-life of 12 months at (2-8°C)"
Real Time Stability (Open Use)	Supports claims: "Sixteen (16) weeks On-Board/Open Use Stability" (This is an improvement from the predicate's 4 weeks as noted in the "Summary of Similarities and Differences" table).

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not explicitly stated. The studies mentioned (Commutability, Precision, Control Value Assignment, Control Range Definition, Stability) would involve a certain number of runs/measurements, but the specific number of "samples" (clinical specimens or control lots) used in these analytical studies is not provided.
Data Provenance (e.g., country of origin, retrospective/prospective): Not specified. These are analytical studies of a quality control material which typically use manufactured lots of the product and potentially stored clinical samples for commutability, so the concept of "country of origin of data" is less relevant than for patient-derived datasets. Whether the studies were retrospective or prospective is not stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable: For a quality control material, the "ground truth" is typically established by the assigned values and ranges based on the manufacturing process and extensive analytical characterization, not by human experts adjudicating clinical cases.

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

Not applicable: There is no mention of adjudication, as this is pertinent to human review of clinical data, which is not the focus of this device's validation.

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:

Not applicable: This device is a quality control material for an immunoassay, not an AI-powered diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are not relevant.

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

Not applicable: This is not an AI algorithm.

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

For the performance of the control material itself: The "ground truth" is based on analytical characterization of the control material (e.g., assigned values, measurement of precision, stability over time) using the LIAISON® EBV IgM assay and Analyzer family, consistent with established laboratory quality control practices. For commutability, it would likely involve testing of diverse clinical samples along with the controls to ensure they behave similarly.

8. The sample size for the training set:

Not applicable: As this is not an AI/ML device, there is no concept of a "training set" for an algorithm.

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

Not applicable: See above.

In summary, the provided document details the regulatory approval (510(k)) of a quality control material, not an AI/ML device. Therefore, the questions designed to probe the validation of an AI/ML system are largely not applicable to this document. The "acceptance criteria" and "performance data" mentioned refer to the analytical performance of the control material itself (e.g., its precision, stability, and commutability with patient samples) rather than the clinical performance of a diagnostic or AI system.

Summary

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

July 11, 2016

DiaSorin Inc. Sandra Zimniewicz Regulatory Affairs Specialist 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285

Re: K161522

Trade/Device Name: LIAISON® EBV IgM Serum Control Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: I Product Code: JJX Dated: May 31, 2016 Received: June 02, 2016

Dear Ms. Zimniewicz:

This letter corrects our substantially equivalent letter of June 30, 2016.

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 (OS) 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 regulations (21 CFR Parts 801 and 809), 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

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

510(k) Number (if known)

Device Name

LIAISON® EBV IgM Serum Control Set

Indications for Use (Describe)

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

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7.0 -510(k) SUMMARY

SUBMITTED BY:	Sandra ZimniewiczRegulatory Affairs SpecialistDiaSorin Inc.1951 Northwestern AvenueP.O. Box 285Stillwater, MN 55082-0285Email: sandra.zimniewicz@diasorin.com
DATE PREPARED:	May 31, 2016
NAME OF DEVICE:
Trade Name:	LIAISON® EBV IgM Serum Control Set
Common Names/Description:	EBV IgM Controls
Classification:	Quality Control Material: 21 CFR 862.1660 Class I, reserved; Microbiology (83)
Product Code:	JJX
PREDICATE DEVICE:	LIAISON® Control EBV IgM (K040120)

DEVICE DESCRIPTION:

The controls are designed for use with DiaSorin LIAISON® EBV IgM assay on the LIAISON® analyzer family.

INTENDED USE:

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

Changes to the DiaSorin LIAISON® EBV IgM 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 EBV IgM and the modified device.

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Summary of Similarities and Differences LIAISON EBV IgM Controls
Characteristic	Predicate DeviceLIAISON® Control EBV IgMK040290, cleared 06/01/2005	Modified DeviceLIAISON® EBV IgM Serum ControlSet
Intended Use	The LIAISON® EBV IgM controls(negative and positive) are used formonitoring substantial reagent failure ofthe LIAISON® EBV IgM chemiluminescentimmunoassay (CLIA). The LIAISON® EBVIgM quality control material contains onlya 5% serum matrix and may notadequately control the DiaSorin LIAISON®EBV IgM assay for serum specimens.	The LIAISON® EBV IgM SerumControls (negative and positive) isintended for use as assayed qualitycontrol samples to monitor theperformance of the LIAISON® EBV IgMassay on the LIAISON® Analyzerfamily.
Negative Control	5% Human Serum/plasma not reactive forVCA IgM antibodies, diluted in PBSbuffer, BSA, with ProClin® 300 as apreservative.	Human Serum/plasma non-reactive forVCA IgM antibodies, 0.1% ProClin®300 and 0.09% sodium azide.
Positive Control	5% Human Serum/plasma reactive forVCA IgM antibodies, diluted in PBSbuffer, BSA, with ProClin® 300 as apreservative and an inert yellow dye.	Human Serum/plasma reactive forVCA IgM 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 2-8ºC	Same
Open Use Stability	Once opened controls are stable for four(4) weeks when properly stored at 2-8ºCbetween uses.	Once opened controls are stable forsixteen (16) weeks when properlystored at 2-8ºC between uses.

SUMMARY OF PERFORMANCE DATA:

Non-clinical verification and validation testing conducted with the LIAISON® EBV IgM 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:

Commutability between Samples and Controls (Matrix Effect) ●
Precision Equivalence between Samples and Controls ●
Control Value Assignment ●
Control Range Definition

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

. Shelf-life of 12 months at (2-8°C)
Sixteen(16) weeks On-Board/Open Use Stability ●

Based on the findings from the validation and verification activities, the modifications to the LIAISON® EBV IgM Serum Control Set do not introduce any new risks to the performance of the device and do not alter safety and effectiveness.

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CONCLUSION:

Modifications 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 is as safe and effective as the predicate and does not raise new questions of safety and efficacy.

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

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.