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 specimens cleared for use on the analyzer. It is only to be used with FDA cleared chemiluminescent immunoassays that are marketed by DiaSorin for the LIAISON® XL Analyzer. The analyzer can be connected to a third party Laboratory Automation System (LAS) which has been previously cleared for use with FDA cleared assays.

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® XL and LIAISON® XL with LIAISON® XL Workcell Upgrade Kit.

Device Description

The LIAISON® XL Analyzer is an in vitro diagnostic device consisting of loading areas (for samples, Reagent Integrals, ancillary reagents, Starter Reagents, Cuvettes, Disposable Tips, water, Wash Buffer, maintenance liquid); incubator, wash station, reader, and a barcode reader for reagents and samples. Installation of the LIAISON® XL Workcell Upgrade Kit allows the LIAISON® XL Analyzer to be used with a compatible LAS and extends the sample pipetting capabilities to a point-in-space located external to the analyzer.

AI/ML Overview

This submission (K141116) describes the LIAISON® XL Workcell Upgrade Kit, which allows the LIAISON® XL Analyzer (predicate device K103529) to connect to a Laboratory Automation System (LAS) and extends its sample pipetting capabilities. The device itself (the Workcell Upgrade Kit) is essentially a modification to the LIAISON® XL Analyzer, enabling new functionality rather than being a diagnostic assay with specific performance metrics like sensitivity or specificity for a disease.

Therefore, the acceptance criteria and study proving its efficacy are focused on demonstrating that the modified LIAISON® XL Analyzer (with the Workcell Upgrade Kit) performs equivalently to the predicate LIAISON® XL Analyzer for its intended use (running the LIAISON® Anti-HAV assay).

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical table of acceptance criteria and performance for a diagnostic assay (e.g., sensitivity, specificity, accuracy). Instead, the acceptance criteria for this device modification are implicitly about maintaining the performance and functional equivalence of the predicate device when the upgrade kit is installed and used, especially when connected to a Laboratory Automation System.

The "device performance" reported is that the new device (LIAISON® XL with Workcell Upgrade Kit) is "substantially equivalent" to the predicate device (LIAISON® XL Analyzer) for its existing intended use with the LIAISON® Anti-HAV assay.

Acceptance Criteria (Implicit)	Reported Device Performance (Implicit)
Maintain the intended use of the LIAISON® Anti-HAV assay.	The intended use of the LIAISON® Anti-HAV assay remains identical for both the predicate and the new device. It is 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, as an aid in diagnosing current or previous HAV infections and determining antibody response in vaccine recipients.
Maintain the fundamental principles of operation.	The principles of operation (Chemiluminescence using magnetic particle solid phase and chemiluminescent tracer, optical system, temperature control, dispense system, reagent handling, starter reagents, reaction modules, test processing, assay protocols, data analysis, QC software, specimens, disposables) are all stated as "Same" between the predicate and the new device.
Ensure proper sample aspiration, identification, and LAS communication.	The new device allows for sample aspiration directly from the sample bay (standalone mode) and from a point-in-space presented by the Workcell to the aspiration point (LAS mode). Sample identification via barcodes is maintained in both standalone and LAS modes (using the Workcell's barcode scanner). The key change and performance element relate to the enabling and proper functioning of the LAS interface communication protocol.
No adverse impact on existing assay performance characteristics.	The submission states that "The results from the non-clinical studies submitted in this premarket notification demonstrate that the LIAISON® XL Workcell Upgrade Kit is substantially equivalent to the predicate device." This implies that existing performance characteristics of the LIAISON® Anti-HAV assay on the LIAISON® XL platform are maintained when the Workcell Upgrade Kit is present and/or utilized. Specific data to support this would be in the non-clinical studies referenced, but not provided in this summary.
Proper functioning of the LAS interface.	The software now has the "LAS interface enabled," and the LIAISON® XL software communicates with the Workcell via a "LAS interface communication protocol." The study would have demonstrated this communication and integrated functionality.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a sample size for a "test set" in the traditional sense of a diagnostic assay evaluation (e.g., number of patient samples for sensitivity/specificity). This submission is for a device modification (an upgrade kit for an existing analyzer) rather than a novel diagnostic assay.

The evaluation would likely involve:

Functional testing: Verifying that the Workcell Upgrade Kit integrates correctly with the LIAISON® XL Analyzer and a Laboratory Automation System.
Performance verification: Ensuring that the LIAISON® Anti-HAV assay, when run on the LIAISON® XL Analyzer with the Workcell Upgrade Kit (especially through LAS integration), yields results consistent with those obtained on the predicate device without the upgrade. This would involve running a series of samples (controls, patient samples) to confirm precision, accuracy, and overall analytical performance are maintained.

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for a device modification, the studies would typically be prospective functional and performance verification studies conducted in a controlled laboratory environment.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This is not a study assessing diagnostic accuracy against a clinical ground truth established by experts. It is a technical submission for a device modification.

4. Adjudication Method:

Not applicable for a device modification study focused on functional and performance equivalence.

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

Not applicable. This is not a study evaluating human reader performance, with or without AI assistance.

6. Standalone Performance:

Yes, a standalone performance was done in the sense that the studies demonstrated that the LIAISON® XL Analyzer with the Workcell Upgrade Kit still functions as a standalone analyzer (where samples are placed directly into the sample bay, as in the predicate device). The capabilities are maintained ("Same (in the stand alone mode)"). Additionally, the primary purpose of the upgrade is to enable the "LAS mode" functionality. The non-clinical studies would have verified the performance of the analyzer both in standalone mode and with the LAS integration.

7. Type of Ground Truth Used:

The "ground truth" for this type of submission would be the established and cleared performance characteristics (e.g., precision, linearity, analytical sensitivity, cut-off values) of the LIAISON® Anti-HAV assay when run on the predicate LIAISON® XL Analyzer. The studies would have demonstrated that the modified analyzer's performance for this assay does not deviate significantly from these established values.

8. Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a distinct training set for algorithm development. The "training" in this context would refer to the development and internal testing of the hardware and software modifications of the Workcell Upgrade Kit to ensure it performs as intended.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there's no machine learning "training set" in the context of this device modification. The "ground truth" for verifying the functional and performance aspects of the Workcell Upgrade Kit would be derived from:

Engineering specifications and design requirements for the Workcell itself and its integration with LAS.
The established performance specifications of the LIAISON® Anti-HAV assay on the predicate LIAISON® XL Analyzer.
Industry standards and regulatory guidelines for laboratory automation and immunoassay systems.

In summary, this 510(k) is about demonstrating substantial equivalence for a modification to an existing device rather than establishing novel diagnostic performance for an assay. The studies focus on ensuring that the new functionalities (LAS connectivity, extended pipetting) correctly integrate without negatively impacting the already cleared performance of the LIAISON® XL Analyzer when running the LIAISON® Anti-HAV assay.

Summary

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KC141116

JUL 2 5 2014

510(k) SUMMARY

SUBMITTED BY:

Mari Mever Director, Regulatory Affairs DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 Phone (651) 439-9710 Fax (651) 351-5669 Email: mari.meyer@diasorin.com

NAME OF DEVICE:

Trade Name:

Common Names/Descriptions:

Regulation Number:

Requlation Name:

Regulation Class:

Product Codes:

PREDICATE DEVICES:

LIASON® Anti-HAV, LIAISON® XL Analyzer

Hepatitis Anti-HAV, serological assay, Automated Chemiluminescent Immunoassay Analyzer

21 CFR 866.3310

Hepatitis A virus (HAV) serological assays

Class II

LOL. JJF

LIAISON® XL Analyzer Reference K103529

DEVICE DESCRIPTION:

INTENDED USE:

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DiaSorin LIAISON® XL Workcell Upgrade Kit

The LIAISON XL Analyzer is an automated discrete continuous loading chemiluminescent immunoassay (CLIA) analyzer for in vitro diagnostic analysis of CLIAs on human specimens cleared for use on the analyzer. It is only to be used with FDA cleared chemiluminescent immunoassays that are marketed by DiaSorin for the LIAISON XL Analyzer. The analyzer can be connected to a third party Laboratory Automation System (LAS) which has been previously cleared for use with FDA cleared assavs.
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® LIAISON® XL and LIAISON® XL with LIAISON® XL Workcell Upgrade Kit.

DESCRIPTION:

COMPARISON TO PREDICATE DEVICE:

The following table compares the LIAISON® XL Analyzer to the LIAISON® XL Workcell Upgrade Kit.

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Summary of Device Similarities and Differences:
Characteristic	Predicate DeviceLIAISON® XL analyzer	New Device: LIAISON® XL with LIAISON®XL Workcell Upgrade Kit
FDA k#	K103529	K141116
Intended Use	The LIAISON® Anti-HAV assay is an in vitrochemiluminescent immunoassay intended for thequalitative detection of total antibodies tohepatitis A (anti-HAV) in human serum andsodium heparin plasma samples using theLIAISON® Analyzer family. The assay isindicated as an aid in the laboratory diagnosis ofcurrent or previous HAV infections inconjunction with other serological and clinicalinformation and to determine the presence of anantibody response to HAV in vaccine recipients.This assay is not intended for screening blood orsolid or soft tissue donors. Assay performancecharacteristics have not been established forimmunocompromised or immunosuppressedpatients. The user is responsible for establishingassay performance characteristics in thesepopulations. Caution: U.S. Federal Law restrictsthis device to sale by or on the order of aphysician.	The LIAISON® Anti-HAV assay is an in vitrochemiluminescent immunoassay intended forthe qualitative detection of total antibodies tohepatitis A (anti-HAV) in human serum andsodium heparin plasma samples using theLIAISON® Analyzer family. The assay isindicated as an aid in the laboratory diagnosisof current or previous HAV infections inconjunction with other serological and clinicalinformation and to determine the presence of anantibody response to HAV in vaccinerecipients.This assay is not intended for screening bloodor solid or soft tissue donors. Assayperformance characteristics have not beenestablished for immunocompromised orimmunosuppressed patients. The user isresponsible for establishing assay performancecharacteristics in these populations. Caution:U.S. Federal Law restricts this device to sale byor on the order of a physician.
	The LIAISON® XL Analyzer is an automateddiscrete continuous loading chemiluminescentimmunoassay (CLIA) analyzer for in vitrodiagnostic analysis of CLIAs on human serum orplasma. The system menu includes infectiousdisease, bone and mineral, and endocrinologyCLIAs. It is to be used only with FDA clearedchemiluminescence immunoassays that aremarketed by DiaSorin for the LIAISON® XLAnalyzer.	The LIAISON XL Analyzer is an automateddiscrete continuous loading chemiluminescentimmunoassay (CLIA) analyzer for in vitrodiagnostic analysis of CLIAs on humanspecimens cleared for use on the analyzer. It isonly to be used with FDA clearedchemiluminescent immunoassays that aremarketed by DiaSorin for the LIAISON XLAnalyzer. The analyzer can be connected to athird party Laboratory Automation System(LAS) which has been previously cleared foruse with FDA cleared assays.
	The LIAISON® Control Anti-HAV (negativeand positive) is intended for use as assayedquality control samples to monitor theperformance of the LIAISON® Anti-HAV assay.The performance characteristics of LIAISON®controls have not been established for any otherassays or instrument platforms different fromLIAISON® and LIAISON® XL.	The LIAISON® Control Anti-HAV (negativeand positive) is intended for use as assayedquality control samples to monitor theperformance of the LIAISON® Anti-HAVassay.The performance characteristics of LIAISON®controls have not been established for any otherassays or instrument platforms different fromLIAISON®, LIAISON® XL and LIAISON® XLwith LIAISON® XL Workcell Upgrade Kit.
Principles ofOperation	Chemiluminescence using magnetic particlesolid phase and chemiluminescent tracer	Same
Characteristic	Predicate DeviceLIAISON® XL analyzer	New Device: LIAISON® XL with LIAISON®XL Workcell Upgrade Kit
FDA k#	K103529	K141116
Optical System	High-sensitive, low-noise photomultipliertube (PMT) operating as an ultra-fastphoton counter. Pulses are amplified by arapid electronic amplifier.Circuit that suppresses PMT signal noise.Linear measuring range: 300 - 650 nmLight peak of chemiluminescence emitted at450 nm	Same
TemperatureControl	Reaction Temperature: 36°C ± 1°CReagent Storage Temperature: 11-15°C	Same
DispenseSystem	Automated pipetting of samples andreagents;Left pipetting unit used for samples(using disposable tip);Right pipetting unit used for reagents(metal needle);	Same
	Precision syringes (sample and reagent)Sample Probe (disposable tip):Liquid Level Detection and ClotDetection feature (pressure)Disposable tips: 6 trays of 96 tips eachcan be loaded on board.Monitored through software counter andpresence sensor upon tip pick-up.Re-loading allowed during run	Same

Summary of Device Similarities and Differences:

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DiaSorin | IAISON® XL Workcell Un de Kit

Characteristic	Predicate DeviceLIAISON® XL analyzer	New Device: LIAISON® XL withLIAISON® XL Workcell Upgrade Kit
	Reagent Probe:• Liquid Level Detection (capacitive), withsoftware tracking of reagent level• Optical Liquid Verification (real-timemonitoring of liquid flow inside theprobe)	Same
Sample Handling	Capacity:• Holds 10 sample racks,• 12 places per rack	Same (in the stand alone mode)
	Tube types:• primary tube• aliquot tube• pediatric	Same
	Sample presence, sample type (calibrator,control, patient), tube size, and processingcompletion tracked by operating softwareand sample bar-code	Same (in the stand alone mode)
Test Orders	From LIS or middleware to analyzer	Same
Test Results	To LIS or middleware from analyzer	Same
Reagent Handling	Capacity: 25 Reagent Integrals (RI), plus 4positions for Ancillary Reagents	Same
	RI contains all reagents required for anygiven assay (up to 7 vials per RI, first vialalways contains magnetic particles).	Same

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	DiaSorin LIAISON® XL Workcell Upgrade Kit
	Assay-specific processing and analysisparameters, calibration, lot number,expiration date, and usage (number oftests run) are controlled by operatingsoftware as communicated by RF-Tag	Same
AdditionalReagents	Control Set (2-3 levels) LIAISON Light Check (diagnostic tool only) LIAISON Starter Kit (Starter Reagents 1 and 2) LIAISON Wash/System Liquid (used as a wash liquid only – immunometric wash step) Purified water is also required as System Liquid, as fluidic filler and to perform: reagent needle cleaning washer needle cleaning A cleaning tank is available to host a cleaning liquid suitable for automated maintenance purpose	Same
Starter Reagents	Level sensing by capacitive rod	Same
	Recognition of Starter Reagents via RF-Tag	Same
	Two bottles of each Starter Reagent can beloaded on board	Same
	Injection of Starter Reagents through highprecision/accuracy pump (fixed dispensingvolume)	Same
	Dispense monitoring through optical sensor	Same
	Injection of Starter Reagents occurs atcontrolled temperature (33-37°C)	Same

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Characteristic	Predicate DeviceLIAISON® XL analyzer	LIAISON® XL Workcell Upgrade Kit
Reaction Modules	Single-cavity CuvettesStorage capacity: >600 CuvettesInventory monitoring through software counter.Sensors detect actual presence of CuvettesReloading allowed during runUnloading automatic into waste bag	SameSameSameSameSameSame
Test Processing	Random Access and BatchContinuous operationSample scheduling optimized throughput process	SameSameSame
Assay Protocols	1-Step assays: 1 incubation sequence / 1 wash sequence; average incubation time = 10 minutes2-Step assays: 2 incubation sequence / 1 or 2 wash sequence(s); average incubation time = 10 minutesTwo-point calibration of assays	SameSameSame
Human Interface	ComputerTouch-screen On Screen Keyboard (keyboard and mouse not supplied)Monitor – touch screen, colorPrinterStationary barcode scanner for identification of samplesStationary RF-Tag reader for identification of reagents (Reagent Integrals and Starter Reagents)Handheld barcode scanner for identification of controls	SameSameSameSameSame(in the stand alone mode)Same
Data Analysis	Automated data reductionAssay-specific Master Curve with 2-point recalibrationAssay-specific data reduction	SameSameSame
QC Software	Stored lot-specific control resultsLot-specific Levey-Jennings plottingTrend identificationStatistical analyses	SameSameSameSame
Specimens	Serum or plasmaSampling from primary, aliquot, or pediatric tubes	SameSame
Disposables	Reagent IntegralsLight Check (diagnostic tool)Starter KitWash/System LiquidCuvettesDisposable TipsWaste Bag	SameSameSameSameSameSameSame
Software	Based on: Windows Vista· Software controlling the analyzer with Graphical User Interface (v4.0.0.4 sp3)· LAS interface disabled	Same· Same· LAS interface enabled
Characteristic	Predicate Device	LIAISON® XL Workcell Upgrade Kit
	LIAISON® XL analyzer
General Operation	The Cuvette sorting mechanism feeds theincubator, in order to have all vacantincubator positions (i.e. 80 incubationslots) always full of Cuvettes available fornew pipetting tasks. Pipetting of sampleand reagents occurs within the incubator.	Same
General Operation	Incubator rotates (CW/CCW) in order tobring the appropriate Cuvette to one of the3 dedicated pipetting positions. At the endof the incubation time, the incubator-washer pusher transports the Cuvettefrom its position in the incubator into thewasher. The washer transportmechanism (spindle) moves the Cuvettespresent in the washer channel one cavityposition at a time, using half of theanalyzer time cycle, from one washingstation to the next. Each of the 6 washerneedles accesses a Cavity only once.Upon completion of the wash step, thefollowing two situations may apply:CASE 1: Return transport for 2-stepprocess.The washer- incubator pusher moves theCuvette back into the incubator (in a vacantincubator slot) for addition of second-stepreagent(s). After incubation, the Cuvettegoes through the washer again.CASE 2: Transport into the measuringchamber.The washer transport mechanism (spindle)moves the Cuvette to the measuringchamber.After the measurement, the reactionsolution is removed by suction and theCuvette then is transported out of themeasuring chamber and into the solid wastebin.	Same

Characteristic	Predicate: LIASON XL AnalyzerK103529LIAISON® XL	New Device: LIASON XL with LIASON XLWorkcell Upgrade KitK141116
Sample Aspiration	Directly from sample tube in thesample bay of the analyzer	Directly from sample tube in thesample bay of the analyzer (in thestand alone mode) and Directly from sample tube presentedby the Workcell to the aspiration point-in-space position at the analyzerinterface (in LAS mode)
Sample Identificationfrom bar-coded tubes	Bar-coded sample tubes (monodimension barcode) read directly byanalyzer bar code reader	Bar-coded sample tubes (monodimension barcode) read directly byanalyzer bar code reader (stand-alone mode) and Bar-coded sample tubes (monodimension barcode) read by Workcellbarcode scanner.
LAS Communication	N/A	LIAISON® XL software communicates withWorkcell via LAS interface communicationprotocol

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. .

. . . . . . . .

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Table 2: Differences

CONCLUSION:

The results from the non-clinical studies submitted in this premarket notification demonstrate that the LIAISON® XL Workcell Upgrade Kit is substantially equivalent to the predicate device.

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Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 25, 2014

DIASORIN, INC. MARI MEYER DIRECTOR, REGULATORY AFFAIRS 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER MN 55082-0285

Re: K141116

Trade/Device Name: LIAISON XL Analyzer with LIAISON XL Workcell Upgrade Kit Regulation Number: 21 CFR 866.3310 Regulation Name: Hepatitis A virus (HAV) serological assays Regulatory Class: II Product Code: LOL, JJF Dated: April 29, 2014 Received: April 30, 2014

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, 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Ms. Meyer

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/Resourcesfor You/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 and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141116

Device Name LIAISON XL Analyzer

Indications for Use (Describe)

This assay is not intended for screening blood 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® 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.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

Stephen J. Lovell -S 2014.07.24 13:38:59 -04'00'

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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.