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

Device Description

The LIAISON® CMV 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® CMV IgM assay on the LIAISON® analyzer family.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "LIAISON® CMV IgM Serum Control Set." This document focuses on the acceptance criteria and the study that proves the device meets those criteria for this specific product.

It's important to understand that this is a quality control material used to monitor the performance of another assay (the LIAISON® CMV IgM assay), not a diagnostic device itself. Therefore, the "performance" here refers to its stability and ability to function as a reliable control, not diagnostic accuracy in identifying patient conditions.

Based on the provided text, here's the information regarding acceptance criteria and the study:

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

The document does not present a formal table of acceptance criteria with specific numerical targets. Instead, it lists the types of studies conducted to demonstrate that the modified device meets "predetermined acceptance criteria" and "design specifications." The reported "performance" is that it successfully met these criteria.

Acceptance Criterion (Implicit)	Reported Device Performance
Functional Equivalence/Commutability (between samples and controls; Matrix Effect)	Demonstrated that the modified device meets predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device.
Precision Equivalence (between samples and controls)	Demonstrated that the modified device meets predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device.
Control Value Assignment	Demonstrated that the modified device meets predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device.
Control Range Definition	Demonstrated that the modified device meets predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device.
Shelf-life Stability (12 months at 2-8°C)	Real Time Stability testing conducted on the LIAISON® CMV IgM Serum Control Set to support the claim.
On-Board/Open Use Stability (16 weeks)	Real Time Stability testing conducted on the LIAISON® CMV IgM Serum Control Set to support the claim. Specifically, "Once opened controls are stable for sixteen (16) weeks when properly stored at 2-8ºC between uses."
No new risks or altered safety/effectiveness	Based on findings from validation and verification activities, "the modifications to the LIAISON® CMV IgM Serum Control Set do not introduce any new risks to the performance of the device and do not alter safety and effectiveness."
Functions as intended and meets design specifications	"Performance testing of the device demonstrates that the device functions as intended, meeting the requirements of design specifications."

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

The document does not specify the sample sizes (e.g., number of control sets, number of runs, number of replicates) used for the verification and validation (test set) studies. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective. Given that it's a 510(k) for a control material, the studies would typically be prospective laboratory-based verification and validation studies.

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 is not applicable in the context of this device. The "ground truth" for a quality control material is its chemical and immunological behavior and stability, not a diagnosis or clinical outcome. The validation is based on analytical performance studies, not expert consensus on patient data.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in diagnostic studies involving human interpretation (e.g., radiology images), not for the analytical performance of a quality control material.

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. MRMC studies are specific to evaluating diagnostic aids, often AI systems, and how they impact human reader performance. This device is a quality control material for an immunoassay, not a diagnostic or AI-powered system that human readers use directly to interpret patient cases.

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

This refers to the performance of the control material itself in the context of the LIAISON® CMV IgM assay. The studies listed ("Commutability," "Precision," "Control Value Assignment," "Control Range Definition," and "Real Time Stability") are inherently "standalone" in that they evaluate the properties of the control material and its interaction with the analyzer and assay without a human "interpretation" component in the process of the control material functioning. It is not an "algorithm" in the sense of AI.

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

The "ground truth" for this quality control material is its pre-established composition and expected analytical performance characteristics based on reference methods and the established performance of the LIAISON® CMV IgM assay it controls. It's an internal, analytical "ground truth" rather than a clinical diagnostic one. For example:

Commutability/Matrix Effect: Related to how the control material behaves similarly to actual patient samples.
Precision: How consistently the control material yields results within a defined range.
Control Value Assignment/Range Definition: Based on a rigorous process to determine the expected signal and acceptable variation for the positive and negative controls.
Stability: Measured by maintaining specified performance characteristics over time.

8. The sample size for the training set

This is not explicitly stated and is not directly applicable in the sense of a machine learning "training set." The development of the control material and the initial characterization of its performance would involve laboratory experiments, but the document doesn't detail the sample sizes of materials used in that developmental phase. The "study that proves the device meets the acceptance criteria" refers to the verification and validation studies, not an AI training process.

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

Not applicable for a "training set" in the context of AI. For the development and characterization of the control material, the "ground truth" (i.e., the target characteristics and performance) would have been established through:

Careful formulation and manufacturing processes.
Protocols for assigning target values and ranges, often using a large number of replicates and statistical methods.
Comparison to existing reference materials or established clinical samples to ensure it behaves diagnostically like patient samples (for commutability).
Controlled environmental conditions and repeated testing for stability.

In summary, this document is a 510(k) for a quality control material, not a diagnostic device that performs clinical interpretation or uses AI. Therefore, many of the questions asked (especially those related to human readers, experts, and AI-specific ground truth/training sets) are not relevant to the type of product described or the studies conducted to support its clearance. The focus is on the analytical performance and stability of the control material itself.

Summary

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

June 30, 2016

DiaSorin Inc. Sandra Zimniewicz Regulatory Affairs Specialist 1951 Northwestern Avenue Stillwater, MN 55082

Re: K161526

Trade/Device Name: LIAISON® CMV 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:

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 (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.

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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/Resourcesfor You/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® CMV IgM Serum Control Set

Indications for Use (Describe)

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

X 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."

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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® CMV IgM Serum Control Set
Common Names/Description:	CMV IgM Controls
Classification:	Quality Control Material: 21 CFR 862.1660Class I, reserved; Microbiology (83)
Product Code:	JJX
PREDICATE DEVICE:	LIAISON® Control CMV IgM (K040290)

DEVICE DESCRIPTION:

The controls are designed for use with DiaSorin LIAISON® CMV 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® CMV IgM 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 CMV IgM and the modified device.

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Summary of Similarities and Differences LIAISON CMV IgM Controls
Characteristic	Predicate DeviceLIAISON® Control CMV IgMK040290, cleared 06/01/2005	Modified DeviceLIAISON® CMV IgM Serum ControlSet
Intended Use	The LIAISON® CMV IgM controls(negative and positive) are used formonitoring substantial reagent failure ofthe LIAISON® CMV IgMchemiluminescent immunoassay (CLIA).The LIAISON® CMV IgM quality controlmaterial contains only a 5% serum matrixand may not adequately control theDiaSorin LIAISON® CMV IgM assay forserum specimens.	The LIAISON® CMV IgM SerumControls (negative and positive) isintended for use as assayed qualitycontrol samples to monitor theperformance of the LIAISON® CMVIgM assay on the LIAISON® Analyzerfamily.
Negative Control	5% Human Serum/plasma not reactive forCMV IgM antibodies, diluted in PBSbuffer, BSA, with ProClin® 300 as apreservative.	Human Serum/plasma non-reactive forCMV IgM antibodies, 0.1% ProClin®300 and 0.09% sodium azide.
Positive Control	5% Human Serum/plasma reactive forCMV IgM antibodies, diluted in PBSbuffer, BSA, with ProClin® 300 as apreservative and an inert yellow dye.	Human Serum/plasma reactive forCMV IgM 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 2-8ºC	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® CMV 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® CMV 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® CMV 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.