(8 days)
Not Found
No
The summary describes a standard immunoassay system and does not mention any AI or ML components in the device description, performance studies, or key metrics.
No.
Explanation: This device is an in vitro diagnostic immunoassay system used for qualitative detection of antibodies, not for therapy. It aids in diagnosis and determining antibody presence but does not treat a condition.
Yes
The device is intended for the qualitative detection of total antibodies to hepatitis A, and the assay is indicated as an aid in the laboratory diagnosis of current or previous HAV infections. This directly supports its role as a diagnostic device.
No
The device description clearly states it is a "fully automated, closed, continuous loading of samples and reagents in vitro diagnostic immunoassay system utilizing chemiluminescent technology" and mentions hardware verification and validation, indicating it is a physical analyzer system, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that 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". This clearly indicates that the device is used to examine specimens taken from the human body.
- Device Description: The "Device Description" further reinforces this by describing the LIAISON® XS Analyzer as a "fully automated, closed, continuous loading of samples and reagents in vitro diagnostic immunoassay system".
- Purpose: The assay is used as an "aid in the laboratory diagnosis of current or previous HAV infections" and "to determine the presence of an antibody response to HAV in vaccine recipients". These are diagnostic purposes.
- Care Setting: The device is intended for use in "professional clinical laboratories", which is a typical setting for IVD devices.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
LOL, JJF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Immunometrical performance was assessed as in the original 510(k) for what is described in Table 6-3 with the assay LIAISON® anti-HAV.
Analytical Sensitivity, as concentration at cut off threshold vs WHO standard preparation:
Acceptance criteria: Analytical sensitivity in the range 15.5 - 21.5 mIU/ml
Found: Run 1: 21 mIU/mL, Run 2: 20 mIU/mL
Acceptance criteria met: Yes
Total precision, as value of the percentage coefficient of variation (CV):
Acceptance criteria: ≤14.5%
Found: 3.3 - 7.2%
Acceptance criteria met: Yes
Positive agreement:
Acceptance criteria: ≥95%
Found: 97.0%
Acceptance criteria met: Yes
Negative agreement:
Acceptance criteria: ≥95%
Found: 98.2%
Acceptance criteria met: Yes
All items relevant for the software were successfully verified and validated.
All items relevant for the hardware were successfully verified and validated.
Key Metrics
Analytical Sensitivity: Run 1: 21 mIU/mL, Run 2: 20 mIU/mL
Total precision (CV): 3.3 - 7.2%
Positive agreement: 97.0%
Negative agreement: 98.2%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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February 9, 2021
DiaSorin Inc. Mari Meyer Vice President, Regulatory and Clinical Affairs, North America 1951 Northwestern Ave Stillwater, Minnesota 55082
Re: K210272
Trade/Device Name: LIAISON Anti-HAV Regulation Number: 21 CFR 866.3310 Regulation Name: Hepatitis A Virus (HAV) Serological Assays Regulatory Class: Class II Product Code: LOL, JJF Dated: January 25, 2021 Received: February 1, 2021
Dear Mari 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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Maria Garcia, Ph.D. Branch Chief Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210272
Device Name LIAISON® Anti-HAV
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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
SECTION 6.0 510(k) SUMMARY
This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.
6.1. SUBMITTER INFORMAITON
| Submitter: | DiaSorin Inc.
1951 Northwestern Avenue
P.O. Box 285
Stillwater, MN 55082-0285 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mari Meyer
Vice President, Regulatory and Clinical Affairs
Email: mari.meyer@diasorin.com
Phone: (715) 410-7149
Fax: (651) 351-5669 |
| Date Summary Prepared: | January 25, 2021 |
6.2. DEVICE INFORMATION
| Proprietary Name: | Liaison® Anti-HAV |
|---|---|
| Common Name: | Hepatitis Anti-HAV, serological assay; |
| Automated Chemiluminescent Immunoassay | |
| Analyzer | |
| Predicate Device: | Liaison® Anti-HAV (K193532) |
6.3. REGULATORY INFORMATION
| Proprietary
Name | Classification
Name | Regulation
Section | Product
Code | Device Class | Classification
Panel |
|----------------------|--------------------------------------------------------|-----------------------|-----------------|--------------|----------------------------------------|
| LIAISON®
Anti-HAV | Hepatitis A
Test (antibody
And Igm
Antibody); | 21 CFR
866.3310 | LOL | Class II | Microbiology |
| LIAISON®
XS | Analyzer,
Chemistry,
Micro, For
Clinical Use | 21 CFR
862.2170 - | JJF | Class I | Microbiology,
Clinical
Chemistry |
6.4. 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.
4
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.
- 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 (isoluminol-antibody 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 magneticles and conjugate into the cuvette, during which the antibody conjuqate 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.
6.5. INTENDED USE /INDICATIONS FOR USE
The Intended Use/Indications for Use of the device as described in its current labeling has not changed as a result of the modifications.
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
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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.
6.6 LIAISON XS Analyzer
The test is run on the LIAISON® XS Analyzer which 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 S.p.A. for the LIAISON® XS instrument.
6.7. REASON FOR SUBMISSION
This Special 510(k) is being filed to seek FDA clearance for the LIAISON® XS analyzer, a modified version of the existing LIAISON® XS analyzer, which is currently cleared (K193532, FDA cleared on March 2, 2020).
6.8. DESCRIPTION OF DEVICE MODIFICATION
A retrospective analysis of complaints filed on the part of DiaSorin to Stratec, the supplier, highlighted a general poor reliability of the reagent pipettor (right pipettor or SPOLV). A modification to the device was then devised to improve the reliability, addressing the following areas:
-
- Composition of the System Liquid (SL from now on), whose salt and surfactant content was reduced or nullified:
-
- Hardware (HW) configuration, adapted to process two different consumables, one for solid phase rinsing in the washer Wash Buffer (WB) and one for the SPOLV line filling and the needle rinsina (SL):
-
- Software (SW) and firmware (FW) update, to properly command the new HW parts and provide the user with the relevant information in the user interface for the proper handling of the various supply.
| Assembly(1), accessory or
process modified | Function | LIAISON® XS Analyzer
(current version cleared as
K193532) | LIAISON® XS Analyzer
modified version |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Formulation of the System
Liquid (SL) | The SL fills the reagent
pipettor line to:
Transmit the motion of
the syringe plunger to
the tip of the pipettor probe so to allow
reagent aspiration and
dispensation, | LIAISON® EASY
Wash/System Liquid is used: it
is a 10x concentrate diluted by
the user with purified water to
the concentration of use. It
features sodium and potassium
chlorides, a phosphate buffer,
Tween 20 as a surfactant and
sodium azide as a preservative. | LIAISON® EASY System
Liquid shall be used: it is a
55.6x concentrate diluted by
the user with purified water to
the concentration of use. It
features sodium and potassium
chlorides, a phosphate buffer,
and sodium azide as a
preservative, at a total solute
final concentration of about |
| | | | |
| | • Cleanse the pipettor
during the probe
washing cycle from
reagent residuals. | | 25% of that of the LIAISON®
EASY Wash/System Liquid. |
| Canister housing the system
liquid | A canister houses the SL in an
amount consistent with the
typical analyser workload | A 5 L tank placed inside the
analyzer connects to the
SPOLV line by the means of a
valve/docking station device
on the bottom of the tank.
Liquid from the very same
tank is fed to the washer also. | A new 10 L canister is placed
outside the system and
connected by the means of an
aspiration probe from the top
to the SPOLV line. |
| Canister housing the Wash
Buffer | A canister houses the WB in an
amount consistent with the
typical analyser workload | A 5 L tank placed inside the
analyzer connects to the
Washer line by the means of a
valve/docking station device
on the bottom of the tank.
Liquid from the very same
tank is fed to the SPOLV also. | A new 10 L canister is placed
outside the system and
connected by the means of an
aspiration probe from the top
to the Washer line. |
| SPOLV fluidic line | The line receives SL from the
relevant tank and feeds it to the
SPOLV | A fluidic line originates from
the single 5 L tanks. By the
mean of a liquid distribution
valve, the liquid is fed to a
pump that delivers it to the
SPOLV. A filtering unit is
present between the pump and
the SPOLV to prevent particles
to reach SPOLV valve. | A fluidic line originates from
the dedicated 10 L tank. The
liquid distribution valve is
suppressed. The liquid is fed to
a pump that delivers it to the
SPOLV. A filtering unit is
present between the tank and
the pump to prevent particles
to reach SPOLV valve. |
| Washer fluidic line | The line receives WB from the
relevant tank and feeds it to the
SPOLV | A fluidic line originates from
the single 5 L tanks. The liquid
is fed to a pump that delivers it
to the washer. | A fluidic line originates from
the dedicated 10 L tank. The
liquid distribution valve is
suppressed. The liquid is fed to
a pump that delivers it to the
washer. |
| Deionized water tank | Deionized water is fed to the
pump and the SPOLV through
a liquid distribution valve. | Deionized water is used to
rinse the syringe to remove
salt/surfactant based solution
when the analyser idles. | As no surfactant based solution
is present any longer for the
SPOLV, the tank is no longer
implemented.
The SPOLV syringe is
periodically rinsed in SL, a
low salt solution. |
| Analyser main SW and FW | Control the functions of the
analyser | The SW/FW is designed to
control all the analyser's
functions, among those the
handling of the liquid
consumables resources. | The SW/FW shall be changed
to a new version, such to
manage the new fluidic layout.
Minor anomalies shall be fixed
as well |
| Intended use of LIAISON®
EASY Wash/System Liquid | LIAISON® EASY
Wash/System Liquid fills the
lines to feed SPOLV and
Washer | LIAISON® EASY
Wash/System Liquid is
required on the LIAISON® XS
Analyzer to wash the magnetic
particles used in LIAISON®
immunoassays, as a system
liquid, and for rinsing the
pipetting needle and tubing
system of the LIAISON® XS
Analyzer | The same liquid shall be only
required on the LIAISON® XS
Analyzer to wash the magnetic
particles used in LIAISON®
immunoassays.
As such, the intended use shall
be consistently limited and the
trade name shall be changed to
LIAISON® EASY Wash
Buffer |
Table 6-1: Describes the changes applied to the LIAISON® XS Analyzer and the handling of the assays run on it.
1 An assembly is a part of an analyzer presiding a given set of actions, operations or processes. An assembly is capable of operating in time with others in order to exchange materials or objects or data.
6
6.9. COMPARISON TO PREDICATE DEVICE
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The following table (Table 6-2) provides a summary of the similarities and differences between the predicate device, the LIAISON Anti-HAV run on LIAISON® XS Analyzer (K193532), and the modified device.
The LIAISON® Anti-HAV component and procedures remain unchanged. The following table provides a detailed comparison of parts, implementation and functions for the current and the modified version of the LIAISON® XS analyzer.
| Feature | LIAISON® Anti-HAV (current version
LIAISON XS Analyzer cleared as
K193532) | LIAISON Anti-HAV (LIAISON® XS
Analyzer modified version) |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | Same |
| Principles of operation | Chemiluminescence using magnetic particle
solid phase and chemiluminescent tracer | Same |
| 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 | Same |
| Temperature Control: Reagent Storage
Temperature | 11-15°C | Same |
| Dispense System | Automated pipetting of samples and reagents.
Left pipetting unit used for samples; right
pipetting unit used for reagents.
Sample pipetting: disposable tip
Precision syringes
Left pipetting unit operates an air displacement
syringe.
Right pipetting unit operates a liquid filled
syringe.
Sample Probe (disposable tip):
Liquid Level Detection and Clot
Detection feature (pressure)
Disposable tips: 2 trays of 96 tips each can be
loaded on board.
Monitored through software counter and
presence sensor upon tip pick-up.
Reloading allowed before run, or pausing the
ongoing tasks during a routine.
Reagent Probe | Same |
| | | |
| | Liquid Level Detection (capacitive),
with software tracking of reagent
level
Optical Liquid Verification (real-time
monitoring of liquid flow inside the
probe) | |
| Sample Handling | Capacity: Holds 4 sample racks, 12 places per
rack | Same |
| | 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 barcode | Same |
| Reagent Handling | Capacity: 10 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 |
| | 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 (RF-ID). | Same |
| Additional Reagents | Control Set (2 or more levels) LIAISON Light Check (diagnostic tool
only, reserved for service intervention) LIAISON® EASY Starter Kit (Starter
Reagents 1 and 2, with different trade
name, but the same formulation as Liaison
Starter Kit) LIAISON® EASY Wash/System Liquid
(used as a wash liquid – immunometric
wash step and fluidic filler) LIAISON® EASY Cleaning Tool. | Control Set (2 levels) LIAISON Light Check (diagnostic tool
only, reserved for service intervention) LIAISON EASY Starter Kit (Starter
Reagents 1 and 2, with different trade
name, but the same formulation as Liaison
Starter Kit) LIAISON® EASY Wash Buffer (used as
a wash liquid - immunometric wash step -
, with different trade name, but the same
formulation as LIAISON® EASY Wash/System Liquid) LIAISON® EASY System Liquid (used
as a fluidic filler and cleaner of the
reagent needle) LIAISON® EASY Cleaning Tool. |
| | In addition:
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 | In addition:
No purified water is used A cleaning tank is available to host a
cleaning liquid suitable for automated
maintenance purpose |
| | Level sensor present | Level sensor present as a capacitive rod |
| Starter reagents | The system can host one set of Starter
Reagents.
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 pump (fixed dispensing
volume) | Same |
| | dispense monitoring through optical sensor
injection of Starter Reagents occurs at | Same |
| Reaction Modules | controlled temperature (33-37°C)
Capacity: Single-cavity Cuvettes | Same |
| | Storage capacity: up to 172 cuvettes | Same |
| | Same | Same |
| | Reloading allowed before run, or pausing the
ongoing tasks during a routine | 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 incubation time = 10 minutes | Same |
| | 2-Step assays: 2 incubation sequence / 1 or 2 wash sequence(s); 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 supplied) | Same |
| | Same (integrated with the computer) | Same |
| | Printer (optional) | Same |
| | 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 |
| | Computer LIS Interface | Same |
| Data Analysis | Automated data reduction | Same |
| | Assay-specific Master Curve with two-point or one-point 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) | Same |
| | LIAISON® EASY Wash/System Liquid | LIAISON® EASY Wash Buffer Same chemical formulation, different trade name |
| | Not present | LIAISON® EASY System Liquid |
| | Cuvettes | Same (same as LIAISON® XL but in dedicated trays) |
| | Disposable Tips | Same |
| | Waste box, single use (dedicated) | Same |
| | Cleaning Kit(dedicated) | Same |
| Software | Based on:
• Windows | Same |
| Hardware | Bench-top, integrated design (PC,
• monitor, keyboard are integrated in the design)
average throughput optimized for
• medium/small laboratories
Data exchange for Reagent Integrals,
• Ancillary Reagents, Starter Reagents via RF-ID technology: higher data exchange, higher reagent traceability allowed
Disposable tip for sample pipetting
• | Same with the following design optimization:
External 10 L canisters to house
• separately diluted LIAISON® EASY Wash Buffer and LIAISON® EASY System Liquid
Changes in the liquid supply lines
• connected with the external tanks |
| Software | Software version 1.3.3 SP2 | Software version 1.3.7.
It integrates the changes needed to support the use of the two external tanks and minor bug |
Table 6-2: Comparison with the predicate device
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6.10. RISK MANAGEMENT
The Risk Management was performed in compliance with EN ISO 14971:2012 Medical Devices - Application of Risk Management to Medical Devices. The Failure Modes Effects Analysis (FMEA) methodology was used to systematically identify, estimate, control and report risks to ensure the development and maintenance of a safe and effective product that meets its intended use.
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6.11. VERIFICATION AND VALIDATION SUMMARY
All verification and validation activities were performed in accordance to 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.
6.12. SUMMARY OF PERFORMANCE DATA
Immunometrical performance was assessed as in the original 510(k) for what is described in Table 6-3 with the assay LIAISON® anti-HAV.
| Parameter | Acceptance criteria | Found | Acceptance criteria
met? |
|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------|--------------------------------------|-----------------------------|
| Analytical Sensitivity, as
concentration at cut off threshold
vs WHO standard preparation | Analytical sensitivity in the range
15.5 - 21.5 mIU/ml | Run 1: 21 mIU/mL
Run 2: 20 mIU/mL | Yes |
| Total precision, as value of the
percentage coefficient of
variation (CV) | ≤14.5% | 3.3 - 7.2% | Yes |
| Positive agreement | ≥95% | 97.0% | Yes |
| Negative agreement | ≥95% | 98.2% | Yes |
Table 6-3: Summary of Immunometrical performance assessment
All items relevant for the software were successfully verified and validated.
All items relevant for the hardware were successfully verified and validated.
6.13. SUBSTANTIAL EQUIVALENCE STATEMENT
All verification and validation testing conducted with the LIAISON Anti-HAV run on the LIAISON® XS Analyzer demonstrate that the modified device met the predetermined acceptance criteria, supporting the determination of substantial equivalence to the predicate device.
The modifications to the predicate device to provide improved sensitivity and stability do not substantially change the device. The validation and verification data demonstrate that the performance of the LIAISON Anti-HAV run on the LIAISON® XS analyzer is substantially equivalent to the predicate device.
6.14. CONCLUSION
The material submitted in this Special 510/k): Device Modifications of the LIAISON® Anti-HAV run on the LIAISON XS Analyzer (k1293532) is complete and supports a substantial equivalence decision. The labeling satisfies the requirements of 21 CFR 809.10.