LIAISON Anti-HAV

K210272 · DiaSorin, Inc. · LOL · Feb 9, 2021 · Microbiology

Device Facts

• Record ID: K210272
• Device Name: LIAISON Anti-HAV
• Applicant: DiaSorin, Inc.
• Product Code: LOL · Microbiology
• Decision Date: Feb 9, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3310
• Device Class: Class 2

Indications for 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® Anti-HAV is a competitive sandwich chemiluminescence immunoassay (CLIA) for qualitative detection of total anti-HAV antibodies. Input: human serum or sodium heparin plasma samples. Operation: magnetic particle solid phase coated with IgG anti-HAV; mouse monoclonal anti-HAV antibody conjugate linked to isoluminol derivative. Competitive binding occurs between specimen anti-HAV and conjugate for fixed HAV antigen. Light signal (RLU) measured by photomultiplier is inversely proportional to anti-HAV concentration. Used in professional clinical laboratories; operated by trained personnel. Output: qualitative anti-HAV status. Clinical decision-making: aids diagnosis of current/previous HAV infection and assessment of vaccine response. Modification (K210272) involves hardware/fluidic changes to LIAISON® XS Analyzer: external 10L canisters for Wash Buffer and System Liquid, removal of deionized water tank, and updated software/firmware to manage new fluidic layout and improve reagent pipettor reliability.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design control activities, risk analysis, and verification/validation of hardware and software modifications demonstrating that fundamental scientific technology remains unchanged.

Technological Characteristics

Microchemistry analyzer for clinical use; utilizes chemiluminescence or similar immunoassay detection principles (implied by LIAISON platform). Hardware and software components modified; system remains consistent with previously cleared LIAISON XS Analyzer technology. Connectivity and operational specifications unchanged.

Indications for Use

Indicated for qualitative detection of total anti-HAV antibodies in human serum and sodium heparin plasma. Used as an aid in laboratory diagnosis of current or previous HAV infection and to determine antibody response in vaccine recipients. Not for screening blood, solid, or soft tissue donors.

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 (K193532)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K210272

B Applicant

DiaSorin Inc.

C Proprietary and Established Names

LIAISON Anti-HAV

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| LOL | Class II | 21 CFR 866.3310 - Hepatitis A Virus (HAV) Serological Assays | MI - Microbiology |
| JJF | Class I | 21 CFR 862.2170 - Micro chemistry analyzer for clinical use | CH - Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II, device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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3. A description of the device **MODIFICATION(S)**, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the **FUNDAMENTAL SCIENTIFIC TECHNOLOGY** of the modified device has not changed. This change was for modifications to software and Hardware for the LIAISON XS Analyzer.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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