Who is the manufacturer of LIAISON XL ANALYZER?

DiaSorin, Inc. filed the 510(k) submission for LIAISON XL ANALYZER (K141116).

What is the FDA product code for LIAISON XL ANALYZER?

LOL. It is classified under 21 CFR 866.3310 as a Class 2 device in the Microbiology panel.

What is the regulatory pathway for LIAISON XL ANALYZER?

510(k) clearance (submission type: Traditional).

What are the predicate devices for LIAISON XL ANALYZER?

LIAISON® XL Analyzer (K103529).

Who can help prepare an FDA 510(k) submission like LIAISON XL ANALYZER?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LIAISON XL ANALYZER

K141116 · DiaSorin, Inc. · LOL · Jul 25, 2014 · Microbiology

Device Facts

Record ID	K141116
Device Name	LIAISON XL ANALYZER
Applicant	DiaSorin, Inc.
Product Code	LOL · Microbiology
Decision Date	Jul 25, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.3310
Device Class	Class 2

Intended Use

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 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.

Device Story

LIAISON XL Analyzer is an automated chemiluminescent immunoassay (CLIA) system for in vitro diagnostics. The Workcell Upgrade Kit enables connection to third-party Laboratory Automation Systems (LAS), extending sample pipetting to an external point-in-space. Input: human serum or plasma samples. Operation: automated sample/reagent pipetting; magnetic particle solid phase; chemiluminescent tracer; incubation; wash cycles; photon counting via photomultiplier tube (PMT). Output: qualitative antibody detection results. Used in clinical laboratories by trained personnel. Healthcare providers use results to aid in HAV infection diagnosis or vaccine response assessment. Benefits: increased laboratory workflow efficiency via LAS integration.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Automated discrete continuous loading CLIA analyzer. Features: magnetic particle solid phase, PMT-based optical system (300-650 nm), 36°C incubation, capacitive liquid level detection, and RF-Tag reagent tracking. Connectivity: standalone or integrated via LAS interface. Software: Windows Vista-based, GUI-controlled. Sterilization: N/A (in vitro diagnostic equipment).

Indications for Use

Indicated for qualitative detection of total anti-HAV antibodies in human serum and sodium heparin plasma. Used as an aid in diagnosing current/previous HAV infection and assessing vaccine response. Not for blood/tissue donor screening. Performance not established for immunocompromised/immunosuppressed patients.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

LIAISON® XL Analyzer (K103529)

Related Devices

K103529 — LIAISON XL ANALYZER MODEL 10050 · DiaSorin, Inc. · Jan 21, 2011
K223403 — LIAISON Anti-HAV; LIAISON XS · DiaSorin, Inc. · Dec 9, 2022
K142758 — ADVIA Centaur HAV total assay · Siemens Healthcare Diagnostics, Inc. · Dec 5, 2014
K082049 — LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV · DiaSorin, Inc. · Dec 5, 2008

Submission Summary (Full Text)

{0}------------------------------------------------ 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: 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. Section 5 {1}------------------------------------------------ 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: 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. ## COMPARISON TO PREDICATE DEVICE: The following table compares the LIAISON® XL Analyzer to the LIAISON® XL Workcell Upgrade Kit. {2}------------------------------------------------ | Summary of Device Similarities and Differences: | | | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | Predicate Device LIAISON® 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 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® 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 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® and LIAISON® XL. | 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. | | Principles of Operation | Chemiluminescence using magnetic particle solid phase and chemiluminescent tracer | Same | | Characteristic | Predicate Device LIAISON® XL analyzer | New Device: LIAISON® XL with LIAISON® XL Workcell Upgrade Kit | | FDA k# | K103529 | K141116 | | Optical System | High-sensitive, low-noise photomultiplier tube (PMT) operating as an ultra-fast photon counter. Pulses are amplified by a rapid electronic amplifier. Circuit that suppresses PMT signal noise. Linear measuring range: 300 - 650 nm Light peak of chemiluminescence emitted at 450 nm | Same | | Temperature Control | Reaction Temperature: 36°C ± 1°C Reagent Storage Temperature: 11-15°C | Same | | Dispense System | Automated pipetting of samples and reagents; 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 Clot Detection feature (pressure) Disposable tips: 6 trays of 96 tips each can be loaded on board. Monitored through software counter and presence sensor upon tip pick-up. Re-loading allowed during run | Same | ## Summary of Device Similarities and Differences: . {3}------------------------------------------------ DiaSorin | IAISON® XL Workcell Un de Kit | Characteristic | Predicate Device LIAISON® XL analyzer | New Device: LIAISON® XL with LIAISON® XL Workcell Upgrade Kit | |------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------| | | Reagent Probe: • Liquid Level Detection (capacitive), with software tracking of reagent level • Optical Liquid Verification (real-time monitoring of liquid flow inside the probe) | 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 processing completion tracked by operating software and 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 4 positions for Ancillary Reagents | Same | | | RI contains all reagents required for any given assay (up to 7 vials per RI, first vial always contains magnetic particles). | Same | {4}------------------------------------------------ | | DiaSorin LIAISON® XL Workcell Upgrade Kit | | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | | Assay-specific processing and analysis parameters, calibration, lot number, expiration date, and usage (number of tests run) are controlled by operating software as communicated by RF-Tag | Same | | Additional Reagents | 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 be loaded on board | Same | | | Injection of Starter Reagents through high precision/accuracy pump (fixed dispensing volume) | Same | | | Dispense monitoring through optical sensor | Same | | | Injection of Starter Reagents occurs at controlled temperature (33-37°C) | Same | {5}------------------------------------------------ | Characteristic | Predicate Device LIAISON® XL analyzer | LIAISON® XL Workcell Upgrade Kit | |-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Reaction Modules | Single-cavity Cuvettes Storage capacity: >600 Cuvettes Inventory monitoring through software counter. Sensors detect actual presence of Cuvettes Reloading allowed during run Unloading automatic into waste bag | Same Same Same Same Same Same | | Test Processing | Random Access and Batch Continuous operation Sample scheduling optimized throughput process | Same Same Same | | Assay Protocols | 1-Step assays: 1 incubation sequence / 1 wash sequence; average incubation time = 10 minutes 2-Step assays: 2 incubation sequence / 1 or 2 wash sequence(s); average incubation time = 10 minutes Two-point calibration of assays | Same Same Same | | Human Interface | Computer Touch-screen On Screen Keyboard (keyboard and mouse not supplied) Monitor – touch screen, color Printer Stationary barcode scanner for identification of samples Stationary RF-Tag reader for identification of reagents (Reagent Integrals and Starter Reagents) Handheld barcode scanner for identification of controls | Same Same Same Same Same (in the stand alone mode) Same | | Data Analysis | Automated data reduction Assay-specific Master Curve with 2-point recalibration Assay-specific data reduction | Same Same Same | | QC Software | Stored lot-specific control results Lot-specific Levey-Jennings plotting Trend identification Statistical analyses | Same Same Same Same | | Specimens | Serum or plasma Sampling from primary, aliquot, or pediatric tubes | Same Same | | Disposables | Reagent Integrals Light Check (diagnostic tool) Starter Kit Wash/System Liquid Cuvettes Disposable Tips Waste Bag | Same Same Same Same Same Same Same | | 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 the incubator, in order to have all vacant incubator positions (i.e. 80 incubation slots) always full of Cuvettes available for new pipetting tasks. Pipetting of sample and reagents occurs within the incubator. | Same | | General Operation | Incubator rotates (CW/CCW) in order to bring the appropriate Cuvette to one of the 3 dedicated pipetting positions. At the end of the incubation time, the incubator- washer pusher transports the Cuvette from its position in the incubator into the washer. The washer transport mechanism (spindle) moves the Cuvettes present in the washer channel one cavity position at a time, using half of the analyzer time cycle, from one washing station to the next. Each of the 6 washer needles accesses a Cavity only once. Upon completion of the wash step, the following two situations may apply: CASE 1: Return transport for 2-step process. The washer- incubator pusher moves the Cuvette back into the incubator (in a vacant incubator slot) for addition of second-step reagent(s). After incubation, the Cuvette goes through the washer again. CASE 2: Transport into the measuring chamber. The washer transport mechanism (spindle) moves the Cuvette to the measuring chamber. After the measurement, the reaction solution is removed by suction and the Cuvette then is transported out of the measuring chamber and into the solid waste bin. | Same | | | | | | Characteristic | Predicate: LIASON XL Analyzer K103529 LIAISON® XL | New Device: LIASON XL with LIASON XL Workcell Upgrade Kit K141116 | | Sample Aspiration | Directly from sample tube in the sample bay of the analyzer | Directly from sample tube in the sample bay of the analyzer (in the stand alone mode) and Directly from sample tube presented by the Workcell to the aspiration point- in-space position at the analyzer interface (in LAS mode) | | Sample Identification from bar-coded tubes | Bar-coded sample tubes (mono dimension barcode) read directly by analyzer bar code reader | Bar-coded sample tubes (mono dimension barcode) read directly by analyzer bar code reader (stand- alone mode) and Bar-coded sample tubes (mono dimension barcode) read by Workcell barcode scanner. | | LAS Communication | N/A | LIAISON® XL software communicates with Workcell via LAS interface communication protocol | {6}------------------------------------------------ . . . . . . . . . . . : . {7}------------------------------------------------ #### 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. . {8}------------------------------------------------ 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. {9}------------------------------------------------ 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 {10}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K141116 Device Name LIAISON XL Analyzer #### Indications for Use (Describe) 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 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. 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' {11}------------------------------------------------ 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.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."