The LIAISON® Anti-HAV assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of total antibodies to hepatitis A (anti-HAV) in human serum and sodium heparin plasma samples using the LIAISON® Analyzer family. The assay is indicated as an aid in the laboratory diagnosis of current or previous HAV infections in conjunction with other serological and clinical information and to determine the presence of an antibody response to HAV in vaccine recipients.

This assay is not intended for screening blood or solid or soft tissue donors. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. The user is responsible for establishing assay performance characteristics in these populations. Caution: U.S. Federal Law restricts this device to sale by or on the order of a physician.

The LIAISON® XL Analyzer is an automated discrete continuous loading chemiluminescent immunoassay (CLIA) analyzer for in vitro diagnostic analysis of CLIAs on human serum or plasma. The system menu includes infectious disease, bone and mineral, and endocrinology CLIAs. It is to be used only with FDA cleared chemiluminescence immunoassays that are marketed by DiaSorin for the LIAISON XL Analyzer.

The LIAISON® Control Anti-HAV (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Anti-HAV assay.

The performance characteristics of LIAISON® controls have not been established for any other assays or instrument platforms different from LIAISON® and LIAISON® XL.

Device Description

The LIAISON® Control Anti-HAV (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Anti-HAV assay.

The performance characteristics of LIAISON® controls have not been established for any other assays or instrument platforms different from LIAISON® and LIAISON® XL.

The method for qualitative determination of anti-HAV is a competitive sandwich chemiluminescence immunoassay (CLIA) based on neutralization. Antibodies to HAV (mouse monoclonal) are used for coating magnetic particles (solid phase) and are linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, anti-HAV present in calibrators, samples or controls binds to a fixed and limited amount of HAV, thus forming an HAV-anti-HAV immune complex. During the second incubation, the antibody conjugate and the solid-phase antibody compete with anti-HAV present in the specimen for HAV, that allows the conjugate to bind to the solid phase and thus form a "sandwich" of conjugate antibody-antigen-solid phase antibody. If all HAV added is sequestered in an HAVanti-HAV immune complex during the first incubation, no sandwich is formed during the second incubation. After the second incubation, the unbound material is removed with a wash cycle.

Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminolantibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is inversely indicative of anti-HAV present in calibrators, samples or controls.

The LIAISON® XL Analyzer is an automated discrete continuous loading chemiluminescent immunoassay analyzer for in vitro diagnostic use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the DiaSorin LIAISON® XL Analyzer, referencing the LIAISON® Anti-HAV assay. However, the document does not contain specific acceptance criteria, comprehensive study results demonstrating performance against numerical criteria, or detailed information about sample sizes, ground truth establishment, or expert qualifications for a performance study.

The submission focuses primarily on demonstrating substantial equivalence of the LIAISON® XL Analyzer to its predicate device, the LIAISON® Analyzer, by comparing their features. While it mentions the intended use of the LIAISON® Anti-HAV assay, it does not provide the clinical study data requested.

Therefore, I cannot populate the table with acceptance criteria and reported performance, nor can I provide the requested details about the study design, sample sizes, experts, or ground truth, as this information is not present in the provided text.

The closest information available is the comparison table between the LIAISON® Analyzer and the LIAISON® XL Analyzer, outlining similarities and differences in their features and operational aspects, rather than performance metrics against specific acceptance criteria for a diagnostic test.

Summary of what can be gleaned from the text (and what is explicitly missing):

Acceptance Criteria & Reported Device Performance: Not provided in the text. The document focuses on demonstrating substantial equivalence to a predicate device through feature comparison, not quantitative performance metrics against pre-defined acceptance criteria for the assay.
Sample Size (Test Set) & Data Provenance: Not provided.
Number of Experts & Qualifications: Not provided.
Adjudication Method: Not provided.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not indicated or described. The device is a laboratory analyzer, not a device requiring human reader interpretation in the context of an MRMC study.
Standalone Performance Study: A standalone performance study for the LIAISON® Anti-HAV assay on the LIAISON® XL Analyzer would typically include data on sensitivity, specificity, accuracy, precision, etc. This information is not present in the provided text, which is a 510(k) summary focused on the analyzer itself and its substantial equivalence to a previous version.
Type of Ground Truth: Not provided.
Sample Size (Training Set): Not applicable, as this is an immunoassay analyzer and assay, not an AI algorithm that requires a training set in that context.
How Ground Truth for Training Set was Established: Not applicable.

Summary

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K103529

DiaSorin LIAISON® XL Analyzer Premarket Notification

5.0 510(k) SUMMARY

SUBMITTED BY:

JAN 2 1 2011

Mari Mever Senior Manager, Regulatory/Clinical Affairs DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 Phone (651) 351-5635 Fax (651) 351-5669 Email: mari.mever@diasorin.com

NAME OF DEVICE:

Trade Name:	LIAISON® Anti-HAV, LIAISON® XL Analyzer
Common Names/Descriptions:	Hepatitis Anti-HAV, serological assay, Automated Chemiluminescent Immunoassay Analyzer
Regulation Number:	21 CFR 866.3310
Regulation Name:	Hepatitis A virus (HAV) serological assays
Regulatory Class:	Class II
Product Code:	LOL, JJF
PREDICATE DEVICES:	LIAISON® Analyzer Reference K082050

DEVICE DESCRIPTION:

INTENDED USE:

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The LIAISON® Control Anti-HAV (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Anti-HAV assay.

The performance characteristics of LIAISON® controls have not been established for any other assays or instrument platforms different from LIAISON® and LIAISON® XL.

DESCRIPTION:

The LIAISON® XL Analyzer is an automated discrete continuous loading chemiluminescent immunoassay analyzer for in vitro diagnostic use.

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COMPARISON TO PREDICATE DEVICE:
The following table compares the LIAISON® XL Analyzer to the LIAISON® Analyzer.

Feature	Summary of Device Similarities and Differences:LIAISON® Analyzer	LIAISON® XL Analyzer
FDA K#	K032844/K082050	N/A
Intended Use	Automated chemiluminescent analyzer for clinical use	Same
Principles of operation	Chemiluminescence using magnetic particle solid phase andchemiluminescent tracer	Same
Optical System	High-sensitive, low-noisephotomultiplier tube (PMT) operatingas an ultra-fast photon counter.Pulses are amplified by a rapidelectronic amplifier.	Same
	Circuit that suppresses PMT signal noise.	Same
	Linear measuring range = 300 – 650 nm	Same
	Light peak of chemiluminescence emitted at 450 nm	Same
Temperature Control:• ReactionTemperature	$36°C±1°C$	$36°C±1°C$
• Reagent StorageTemperature	12-19°C	11-15°C
Dispense System	Automated pipetting of samples andreagents. Left pipetting unit used forsamples; right pipetting unit used forreagents	same(sample pipetting: disposable tip)
	Precision syringes (sample and reagent)	same
	Sample Probe:• Liquid Level Detection(capacitive)• Clot Detection feature(software algorithm based oncapacitive signal)	Sample Probe (disposable tip):• Liquid Level Detection and• Clot Detection feature(pressure)
	N/A	Disposable tips: 6 trays of 96 tipseach can be loaded on board.Monitored through softwarecounter and presence sensorupon tip pick-up.Reloading allowed during run
	Reagent Probes:• Liquid Level Detection(capacitive), with softwaretracking of reagent level	Reagent Probes:• Liquid Level Detection(capacitive), with softwaretracking of reagent level• Optical Liquid Verification(real-time monitoring ofliquid flow inside theprobe)
Feature	LIAISON® Analyzer	LIAISON® XL Analyzer
Sample Handling	Capacity: Holds 12 sample racks, 12places per rackTube types:- primary tube- aliquot tube- pediatricSample presence, sample type(calibrator, control, patient), tube size,and processing completion tracked byoperating software and samplebarcode	Capacity: Holds 10 sample racks,12 places per racksamesame
Reagent Handling	Capacity: 15 Reagent Integrals (RI)RI contains all reagents required forany given assay (up to 7 vials per RI,first always contains magneticparticles).Assay-specific processing andanalysis parameters, calibration, lotnumber, expiration date, and usage(number of tests run) are controlledby operating software ascommunicated by barcode.	Capacity: 25 Reagent Integrals(RI), plus 4 positions for AncillaryReagentssameAssay-specific processing andanalysis parameters, calibration,lot number, expiration date, andusage (number of tests run) arecontrolled by operating softwareas communicated by RF-Tag (RF-ID).
Additional Reagents	• Control Set (2-3 levels)• LIAISON Light Check (diagnostictool only)• LIAISON Starter Kit (StarterReagents 1 and 2)• LIAISON Wash/System Liquid• LIAISON Cleaning Kit	• Control Set (2-3 levels)• LIAISON Light Check(diagnostic tool only)• LIAISON Starter Kit (StarterReagents 1 and 2)• LIAISON Wash/SystemLiquid (used as a wash liquidonly - immunometric washstep)• LIAISON Cleaning KitIn addition:• Purified water is also requiredas System Liquid, as fluidicfiller and to perform:- reagent needle cleaning- washer needle cleaning• A cleaning tank is available tohost a cleaning liquid suitablefor automated maintenancepurpose
	Level sensing by capacitive rod	same
Reaction Modules	Capacity: 6 individual reactioncompartments per Reaction ModuleStorage capacity: maximum 120strips stored in LIAISON stacker	Single-cavity CuvettesStorage capacity: >600 Cuvettes
Feature	LIAISON® Analyzer	LIAISON® XL Analyzer
Reaction Modules (cont.)	Sensors detect presence of ReactionModules, and loading and occupancyof stacker.	Inventory monitoring throughsoftware counter.Sensors detect actual presenceof Cuvettes
	Reloading allowed during run	same
Test Processing	Unloading automatic into waste bagRandom Access and Batch	same
	Continuous operation	same
	Sample scheduling optimized forthroughput	same
Assay Protocols	1-Step assays: 1 incubation sequence/ 1 wash sequence; averageincubation time = 10 minutes	same
	2-Step assays: 2 incubation sequence/ 1 or 2 wash sequence(s); averageincubation time = 10 minutes	same
	Two-point calibration of assays	same
Human Interface	Computer Mouse and keyboard	Touch-screen On ScreenKeyboard
	Monitor - touch screen, color Printer Stationary barcode scanners foridentification of samples andreagents	same Printer (optional) Stationary barcode scannerfor identification of samples Stationary RF-Tag reader foridentification of reagents(Reagent Integrals andStarter Reagents) Handheld barcode scannerfor identification of controls
	Computer LIS Interface	same
Data Analysis	Automated data reduction	same
	Assay-specific Master Curve with 2-point recalibration	same
	Assay-specific data reduction	same
QC Software	Stored lot-specific control results	same
	Lot-specific Levey-Jennings plotting	same
	Trend identification	same
	Statistical analyses	same
Specimens	Serum or plasma	same
	Sampling from primary, aliquot, orpediatric tubes	same
Disposables	Reagent Integrals Light Check (diagnostic tool) Starter Kit Wash/System Liquid Reaction Modules	same
	N/A	Cuvettes Disposable Tips
	Waste Bag Cleaning Kit	same (dedicated)
Feature	LIAISON® Analyzer	LIAISON® XL Analyzer
Hardware Improvements	LIAISON® Analyzer	LIAISON® Analyzer, with enhancements as follows:floor-standing, integrated design improved average throughput, Improved data exchange for Reagent Integrals, Ancillary Reagents, Starter Reagents via RF-ID technology Disposable tip for sample pipetting Continuous loading of all liquid and solid resources or waste Increased liquid/reagent capacity Increased efficiency of washer needle cleaning Automated Maintenance tasks On-line help: User Manual and Quick Guide directly accessible on screen

Summary of Device Similarities and Differences:

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CONCLUSION:

The material submitted in this premarket notification is complete and supports the substantial equivalence of the LIAISON® XL Analyzer to the predicate device.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

DiaSorin, Inc. Attn: Mari Meyer 1951 Northwestern Ave. P.O. Box 285 Stillwater, MN 55082

JAN 2 1 201

Re: K103529

Trade/Device Name: LIAISON Anti-HAV, LIAISON XL Analyzer Regulation Number: 21 CFR 866.3310 Regulation Name: Hepatitis A virus (HAV) serological assays Regulatory Class: Class II Product Code: LOL, JJF Dated: November 30, 2010 Received: December 1, 2010

Dear Ms. Meyer:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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

Commission of the

Section of the country of the county

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Page 2 - Mari Meyer

CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Vacayartyr

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K103529

LIAISON® Anti-HAV, LIAISON® XL Analyzer Device Name:

Indications For Use:

The LIAISON® XL Analyzer is an automated discrete continuous loading chemiluminescent immunoassay (CLIA) analyzer for in vitro diagnostic analysis of CLIAs on human serum or plasma. The system menu includes infectious disease, bone and mineral, and endocrinology CLIAs. It is to be used only with FDA cleared chemilyminescence immunoassays that are marketed by DiaSorin for the LIAISON XL Analyzer.

The LIAISON® Control Anti-HAV (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Anti-HAV assay.

The performance characteristics of LIAISON® controls have not been established for any other assays or instrument platforms different from LIAISON® and LIAISON® XL.

Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Uhe Gey

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k 103529

Page 1 of 1

Regulation Number and Section

§ 866.3310 Hepatitis A virus (HAV) serological assays.

(a)
Identification. HAV serological assays are devices that consist of antigens and antisera for the detection of hepatitis A virus-specific IgM, IgG, or total antibodies (IgM and IgG), in human serum or plasma. These devices are used for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis to determine if an individual has been previously infected with HAV, or as an aid to identify HAV-susceptible individuals. The detection of these antibodies aids in the clinical laboratory diagnosis of an acute or past infection by HAV in conjunction with other clinical laboratory findings. These devices are not intended for screening blood or solid or soft tissue donors.(b)
Classification. Class II (special controls). The special control is “Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Hepatitis A Virus Serological Assays.” See § 866.1(e) for the availability of this guidance document.