LIAISON Anti-HAV; LIAISON XS

K223403 · DiaSorin, Inc. · LOL · Dec 9, 2022 · Microbiology

Device Facts

• Record ID: K223403
• Device Name: LIAISON Anti-HAV; LIAISON XS
• Applicant: DiaSorin, Inc.
• Product Code: LOL · Microbiology
• Decision Date: Dec 9, 2022
• Decision: SESE
• Submission Type: Special
• 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.

Device Story

LIAISON XS is a fully automated, closed, continuous-loading chemiluminescent immunoassay analyzer for professional clinical laboratories. It processes human serum or sodium heparin plasma samples. The system uses magnetic microparticles coated with HAV-specific antibodies and isoluminol-antibody conjugates. In a competitive sandwich immunoassay, patient anti-HAV competes with conjugate for binding sites on HAV antigen; light signal (RLU) measured by a photomultiplier is inversely proportional to anti-HAV concentration. The analyzer automates sample/reagent pipetting, incubation, washing, and signal detection. Results are displayed via an integrated touchscreen interface, aiding clinicians in diagnosing HAV infection or confirming vaccine response. Modifications in this version include internal 5L and 3L canisters for system liquid and wash buffer, updated liquid supply lines, and firmware/software version 1.5.2 to support these hardware changes.

Clinical Evidence

No clinical data provided. The submission relies on design control activities, risk analysis, and verification/validation testing to demonstrate that modifications to the LIAISON XS analyzer do not affect performance.

Technological Characteristics

Automated immunoassay analyzer (LIAISON XS). Hardware and software modifications implemented. Fundamental scientific technology (chemiluminescence immunoassay) remains unchanged from the predicate. System is designed for laboratory use.

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 or previous HAV infection and assessing antibody response in vaccine recipients. Not for blood, solid, or soft tissue donor screening.

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® Anti-HAV, LIAISON® XS (K210272)

Submission Summary (Full Text)

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December 9, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

DiaSorin Inc. Kerrie Oetter Director, Regulatory Affairs 1951 Northwestern Ave. P.O. Box 285 Stillwater, Minnesota 55082

Re: K223403

Trade/Device Name: LIAISON Anti-HAV; LIAISON XS Regulation Number: 21 CFR 866.3310 Regulation Name: Hepatitis A Virus (HAV) Serological Assays Regulatory Class: Class II Product Code: LOL Dated: November 8, 2022 Received: November 9, 2022

Dear Kerrie Oetter:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Maria I. Garcia -S

Maria Garcia, Ph.D. Assistant Director Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K223403

Device Name LIAISON Anti-HAV LIAISON XS

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 solid or soft tissue donors.

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

| <span> <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> □ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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| 510(k) Summary | K223403 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted by: | Kerrie Oetter<br>Director, Regulatory Affairs<br>DiaSorin Inc.<br>1951 Northwestern Avenue<br>P.O. Box 285<br>Stillwater, MN 55082-0285<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date prepared: | December 8, 2022 |
| Name of device:<br>Trade Name: | LIAISON® Anti-HAV;<br>LIAISON® XS |
| Common Name: | Hepatitis Anti-HAV, serological assay;<br>Automated Chemiluminescent Immunoassay<br>Analyzer |
| Classification Name: | Hepatitis A Test (antibody and IgM antibody):<br>Class II, 21 CFR 866.3310; Microbiology;<br>Analyzer, Chemistry, Micro, For Clinical Use:<br>Class I, 21 CFR 862.2170; Microbiology, Clinical |
| Product Code: | LOL<br>JJF |
| Predicate Device: | LIAISON® Anti-HAV, LIAISON® XS (K210272) |

### Device Description

#### LIAISON® XS Analyzer

The DiaSorin LIAISON® XS Analyzer is a fully automated, closed, continuous loading of samples and reagents in vitro diagnostic immunoassay system utilizing chemiluminescent technology to provide rapid sample results. The analyzer uses DiaSorin proprietary reagents in which chemiluminescence of an analyte is measured in a sample by the reaction of a magnetic particle solid phase coated with antigen or antibody and a chemiluminescent tracer. The LIAISON® XS Analyzer is intended for use in professional clinical laboratories only.

The general operation of the Analyzer is described below.

- The gripper transports the cuvette inside the incubator in which dedicated positions allowed . the pipetting of reagents and samples. The incubator is provided with 32 plus 25 positions for the placement of cuvettes.

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DiaSorin LIAISON® XS Analyzer Special 510(k): Device modification 510(k) Summary

- At the end of the incubation time, the gripper transports the cuvette from its position in the ● incubator into the washer with three wash positions. The washer transport mechanism moves the cuvette, using the analyzer time cycle, from one washing station to the next.
- . After passing through the washer, the gripper moves the cuvette:
- . CASE 1: Return transport for 2-step process Back in the incubator for addition of second-step reagent(s). After incubation, the gripper moves back the cuvette in the washer.
- . CASE 2: Transport into the measuring chamber for 1-step process In the measuring chamber.
- . After the measurement, the reaction solution is removed by suction and the cuvette is then automatically disposed of into the waste container.

#### LIAISON® Anti-HAV Assay

The method for qualitative determination of anti-HAV is a competitive sandwich chemiluminescence immunoassay (CLIA) based on neutralization. The assay uses magnetic particles (solid phase) coated with IgG antibodies to HAV (mouse monoclonal), and a mouse monoclonal anti-HAV antibody conjugate linked to an isoluminol derivative (isoluminolantibody conjugate). The first incubation step consists of adding the HAV antigen to calibrators, samples or controls, during which 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. After this step the second incubation follows and it involves addition of magnetic microparticles and conjugate into the cuvette, during which the antibody conjugate and the solid-phase antibody compete with anti-HAV present in the specimen for HAV. This allows the conjugate to bind to the solid phase and to form a sandwich. If all HAV added is sequestered in an HAV-anti-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 isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is inversely indicative of anti-HAV present in calibrators, samples or controls.

#### Intended Use/Indications for Use

The Intended Use/Indications for Use of the device as described in its current labeling (K210272) has not changed as a result of the modifications.

The LIAISON® XS Analyzer is a Diagnostic System that measures chemiluminescence. It is intended strictly for professional in-vitro Diagnostic use. It is to be used only with Chemiluminescence Immunoassays, authorized by DiaSorin Italia S.p.A. for the LIAISON® XS instrument.

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.

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This assay is not intended for screening blood or solid or soft tissue donors.

#### Comparison to Predicate Device

The device configuration of the LIAISON® XS Analyzer was modified to return it to the initial configuration (cleared under K193532) where onboard canisters for the supply of liquids are moved back onboard the Analyzer. These modifications include:

- 1. Hardware (HW) configuration, adapted to the new onboard canisters;
- 2. Firmware (FW) and Software (SW), adapted to support the re-arranged HW and provide proper information about the various supplies in the main User Interface;
- 3. New version of Wash Buffer consumable, adapted to the new onboard canister.

A comparison of the similarities and differences between the devices is provided in the following table.

| Feature | LIAISON® XS Analyzer (current version cleared as<br>K210272) | LIAISON® XS Analyzer<br>modified version |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Automated chemiluminescent analyzer for clinical use | Same |
| Principles of operation | Chemiluminescence using magnetic particle solid phase and<br>chemiluminescent tracer | Same |
| Optical System | High-sensitive, low-noise photomultiplier tube (PMT) operating<br>as an ultra-fast photon counter. Pulses are amplified by a rapid<br>electronic 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: Reaction<br>Temperature | 36°C±1°C | Same |
| Temperature Control: Reagent<br>Storage Temperature | 11-15°C | Same |
| Dispense System | Automated pipetting of samples and reagents. Left pipetting unit<br>used for samples; right pipetting unit used for reagents.<br>Sample pipetting: disposable tip | Same |
| | Precision syringes<br>Left pipetting unit operates an air displacement syringe.<br>Right pipetting unit operates a liquid filled syringe. | Same |
| | Sample Probe (disposable tip):<br>Liquid Level Detection and Clot Detection feature<br>(pressure) | Same |
| | Disposable tips: 2 trays of 96 tips each can be loaded onboard.<br>Monitored through software counter and presence sensor upon<br>tip pick-up.<br>Reloading allowed before run, or pausing the ongoing tasks<br>during a routine. | Same |
| | Reagent Probe:<br>Liquid Level Detection (capacitive), with software<br>tracking of reagent level<br>Optical Liquid Verification (real-time monitoring of<br>liquid flow inside the probe) | Same |
| Sample Handling | Capacity: Holds 4 sample racks, 12 places per rack | Same |
| | Tube types:<br>- primary tube<br>- aliquot tube<br>- pediatric | Same |
| Feature | LIAISON® XS Analyzer (current version cleared as<br>K210272) | LIAISON® XS Analyzer<br>modified version |
| | Sample presence, sample type (calibrator, control, patient), tube<br>size, and processing completion tracked by operating software<br>and sample barcode | Same |
| Reagent Handling | Capacity: 10 Reagent Integrals (RI), plus 4 positions for<br>Ancillary Reagents | Same |
| | RI contains all reagents required for any given assay (up to 7<br>vials per RI, first vial always contains magnetic particles). | Same |
| | Assay-specific processing and analysis parameters, calibration,<br>lot number, expiration date, and usage (number of tests run) are<br>controlled by operating software as communicated by RF-Tag<br>(RF-ID). | Same |
| Additional Reagents | Control Set (2 levels)<br>•<br>LIAISON Light Check (diagnostic tool only, reserved for<br>service intervention)<br>•<br>LIAISON® EASY Cleaning Tool | Same |
| Starter reagents | The system can host one set of Starter Reagents.<br>Recognition of Starter Reagents: via RF-Tag | Same |
| | One bottle of each Starter reagent can be loaded on board | Same |
| | Injection of Starter Reagents through high precision/accuracy<br>pump (fixed dispensing volume) | Same |
| | dispense monitoring through optical sensor | Same |
| | injection of Starter Reagents occurs at controlled temperature<br>(33-37°C) | Same |
| Reaction Modules | Capacity: Single-cavity Cuvettes | Same |
| | Storage capacity: up to 172 cuvettes | Same |
| | Same | Same |
| | Reloading allowed before run, or pausing the ongoing tasks<br>during a routine | Same |
| | Unloading automatic into waste container | Same |
| Test Processing | Random Access and Batch | Same |
| | Continuous operation | Same |
| | Sample scheduling optimized for throughput | Same |
| Assay Protocols | 1-Step assays: 1 incubation sequence / 1 wash sequence; average<br>incubation time = 10 minutes | Same |
| | 2-Step assays: 2 incubation sequence / 1 or 2 wash sequence(s);<br>average incubation time = 10 minutes | Same |
| | Two-point and one-point calibration of assays | Same |
| Human Interface | Same | Same |
| | Touch-screen On Screen Keyboard (keyboard and mouse not<br>supplied) | Same |
| | Same (integrated with the computer) | Same |
| | Printer (optional) | Same |
| | Stationary barcode scanner for identification of samples.<br>Stationary RF-Tag reader for identification of reagents. (Reagent<br>Integrals and Starter Reagents).<br>Handheld barcode scanner for identification of controls.<br>Computer LIS Interface | Same |
| Data Analysis | Automated data reduction | Same |
| | Assay-specific Master Curve with two-point or one-point<br>recalibration | Same |
| | Assay-specific data reduction | Same |
| Specimens | Serum or plasma or other body fluids or their extract | Same |
| | Sampling from primary, aliquot, or pediatric tubes | Same |
| Disposables | Reagent Integrals | Same |
| | Light Check (tool for service intervention only)<br>LIAISON® EASY Wash Buffer | Same<br>Only difference is that LIAISON®<br>EASY Wash Buffer is supplied in<br>bottles with 300 mL filling volume<br>instead of 500 mL filling volume.<br>Product code and chemical formulation<br>are the same. |
| | LIAISON® EASY System Liquid | Same |
| | LIAISON EASY Starter Kit | Same |
| | Cuvettes | Same |
| Feature | LIAISON® XS Analyzer (current version cleared as<br>K210272) | LIAISON® XS Analyzer<br>modified version |
| | Disposable Tips | Same |
| | Waste box, single use (dedicated) | Same |
| | Cleaning Kit(dedicated) | Same |
| Software | Based on:<br>● Windows | Same |
| Hardware | ● Bench-top, integrated design (PC, monitor, keyboard are<br>integrated in the design)<br>● average throughput optimized for medium/small<br>laboratories<br>● Data exchange for Reagent Integrals, Ancillary Reagents,<br>Starter Reagents via RF-ID technology: higher data<br>exchange, higher reagent traceability allowed<br>● Disposable tip for sample pipetting | Same with the following design<br>optimization:<br>● Internal 5 L canister to house<br>diluted LIAISON® EASY System<br>Liquid<br>● Internal 3L canister to house<br>LIAISON® EASY Wash Buffer<br>● Changes in the liquid supply lines<br>connected to the new internal<br>canisters |
| Software | Software version 1.4.9 | Software version 1.5.2.<br>It integrates the changes needed to<br>support the use of the two internal tanks<br>and minor bug fixing from the previous<br>version. |

Table 1: Comparison of the LIAISON® XS Analyzer with the predicate device

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#### Summary of Performance Data

Non-clinical verification and validation activities conducted with the LIAISON® XS Analyzer demonstrate that the modified device met predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device. All verification and validation activities were performed in accordance with relevant standards, established plans, protocols, and Design Control procedures. Testing verified all acceptance criteria were met. Verification of the changes did not raise any new items of safety and effectiveness. Evidence is demonstrated through the following studies:

- Non-regression testing of immunometrical performance
- Hardware reliability evaluation .
- Usability testing ●
- Software verification and validation .

Based on the results from the verification and validation activities, the modifications to the LIAISON® XS Analyzer do not introduce any new risks to the performance of the device and do no alter safety and effectiveness.

#### Conclusion

The material submitted in this premarket notification is complete and supports a determination of substantial equivalence to the previous System configuration. The labeling is sufficient and satisfies the requirements of 21 CFR 809.10.