(8 days)
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.
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 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 information provided pertains to the DiaSorin LIAISON® Anti-HAV assay running on the LIAISON® XS Analyzer. This premarket notification is a "Special 510(k)" for device modifications to the existing LIAISON® XS analyzer (K193532), primarily addressing improvements in reliability related to the reagent pipettor. The LIAISON® Anti-HAV assay component and procedures themselves remain unchanged.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance criteria | Reported Device Performance | 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/mLRun 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 |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set for the immunometrical performance assessment.
- Data Provenance: Not specified. It's unclear if the data is retrospective or prospective, or the country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of in vitro diagnostic device (immunoassay). Ground truth for these assays is typically established by reference methods or clinical diagnosis, not by experts reviewing images or other data.
4. Adjudication method for the test set
Not applicable for this type of in vitro diagnostic device. Result determination is quantitative or qualitative based on the assay's output measurements against a defined cutoff, not through expert adjudication of individual cases.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with imaging devices or AI-assisted diagnostic tools where human readers interpret results. The LIAISON® Anti-HAV assay is an automated chemiluminescent immunoassay.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance presented in Table 6-3 represents the standalone performance of the LIAISON® Anti-HAV assay on the modified LIAISON® XS Analyzer. This device is an automated immunoassay system, and its output is directly interpreted as a qualitative detection of antibodies.
7. The type of ground truth used
The ground truth for the immunometrical performance assessment:
- Analytical Sensitivity: Established against a "WHO standard preparation."
- Positive/Negative Agreement: Implied to be established against a reference method or clinical diagnosis for Hepatitis A infection, as is standard for serological assays. The document does not explicitly name the specific reference method used for establishing positive and negative agreement.
8. The sample size for the training set
The document does not provide information regarding a separate "training set" or its sample size. For an immunoassay like this, the development likely involves optimization and validation steps, but not a distinct "training set" in the machine learning sense. The performance data presented is for the evaluation of the validated device.
9. How the ground truth for the training set was established
As there is no explicit mention of a training set in the context of machine learning, there is no information on how its ground truth was established. The development of such an assay involves careful analytical and clinical validation, ensuring its performance aligns with established diagnostic standards.
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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
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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
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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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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 AvenueP.O. Box 285Stillwater, MN 55082-0285 |
|---|---|
| Contact: | Mari MeyerVice President, Regulatory and Clinical AffairsEmail: mari.meyer@diasorin.comPhone: (715) 410-7149Fax: (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 ImmunoassayAnalyzer |
| Predicate Device: | Liaison® Anti-HAV (K193532) |
6.3. REGULATORY INFORMATION
| ProprietaryName | ClassificationName | RegulationSection | ProductCode | Device Class | ClassificationPanel |
|---|---|---|---|---|---|
| LIAISON®Anti-HAV | Hepatitis ATest (antibodyAnd IgmAntibody); | 21 CFR866.3310 | LOL | Class II | Microbiology |
| LIAISON®XS | Analyzer,Chemistry,Micro, ForClinical Use | 21 CFR862.2170 - | JJF | Class I | Microbiology,ClinicalChemistry |
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.
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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 orprocess modified | Function | LIAISON® XS Analyzer(current version cleared asK193532) | LIAISON® XS Analyzermodified version |
|---|---|---|---|
| Formulation of the SystemLiquid (SL) | The SL fills the reagentpipettor line to:Transmit the motion ofthe syringe plunger tothe tip of the pipettor probe so to allowreagent aspiration anddispensation, | LIAISON® EASYWash/System Liquid is used: itis a 10x concentrate diluted bythe user with purified water tothe concentration of use. Itfeatures sodium and potassiumchlorides, a phosphate buffer,Tween 20 as a surfactant andsodium azide as a preservative. | LIAISON® EASY SystemLiquid shall be used: it is a55.6x concentrate diluted bythe user with purified water tothe concentration of use. Itfeatures sodium and potassiumchlorides, a phosphate buffer,and sodium azide as apreservative, at a total solutefinal concentration of about |
| • Cleanse the pipettorduring the probewashing cycle fromreagent residuals. | 25% of that of the LIAISON®EASY Wash/System Liquid. | ||
| Canister housing the systemliquid | A canister houses the SL in anamount consistent with thetypical analyser workload | A 5 L tank placed inside theanalyzer connects to theSPOLV line by the means of avalve/docking station deviceon the bottom of the tank.Liquid from the very sametank is fed to the washer also. | A new 10 L canister is placedoutside the system andconnected by the means of anaspiration probe from the topto the SPOLV line. |
| Canister housing the WashBuffer | A canister houses the WB in anamount consistent with thetypical analyser workload | A 5 L tank placed inside theanalyzer connects to theWasher line by the means of avalve/docking station deviceon the bottom of the tank.Liquid from the very sametank is fed to the SPOLV also. | A new 10 L canister is placedoutside the system andconnected by the means of anaspiration probe from the topto the Washer line. |
| SPOLV fluidic line | The line receives SL from therelevant tank and feeds it to theSPOLV | A fluidic line originates fromthe single 5 L tanks. By themean of a liquid distributionvalve, the liquid is fed to apump that delivers it to theSPOLV. A filtering unit ispresent between the pump andthe SPOLV to prevent particlesto reach SPOLV valve. | A fluidic line originates fromthe dedicated 10 L tank. Theliquid distribution valve issuppressed. The liquid is fed toa pump that delivers it to theSPOLV. A filtering unit ispresent between the tank andthe pump to prevent particlesto reach SPOLV valve. |
| Washer fluidic line | The line receives WB from therelevant tank and feeds it to theSPOLV | A fluidic line originates fromthe single 5 L tanks. The liquidis fed to a pump that delivers itto the washer. | A fluidic line originates fromthe dedicated 10 L tank. Theliquid distribution valve issuppressed. The liquid is fed toa pump that delivers it to thewasher. |
| Deionized water tank | Deionized water is fed to thepump and the SPOLV througha liquid distribution valve. | Deionized water is used torinse the syringe to removesalt/surfactant based solutionwhen the analyser idles. | As no surfactant based solutionis present any longer for theSPOLV, the tank is no longerimplemented.The SPOLV syringe isperiodically rinsed in SL, alow salt solution. |
| Analyser main SW and FW | Control the functions of theanalyser | The SW/FW is designed tocontrol all the analyser'sfunctions, among those thehandling of the liquidconsumables resources. | The SW/FW shall be changedto a new version, such tomanage the new fluidic layout.Minor anomalies shall be fixedas well |
| Intended use of LIAISON®EASY Wash/System Liquid | LIAISON® EASYWash/System Liquid fills thelines to feed SPOLV andWasher | LIAISON® EASYWash/System Liquid isrequired on the LIAISON® XSAnalyzer to wash the magneticparticles used in LIAISON®immunoassays, as a systemliquid, and for rinsing thepipetting needle and tubingsystem of the LIAISON® XSAnalyzer | The same liquid shall be onlyrequired on the LIAISON® XSAnalyzer to wash the magneticparticles used in LIAISON®immunoassays.As such, the intended use shallbe consistently limited and thetrade name shall be changed toLIAISON® EASY WashBuffer |
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.
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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 versionLIAISON XS Analyzer cleared asK193532) | LIAISON Anti-HAV (LIAISON® XSAnalyzer modified version) |
|---|---|---|
| Intended Use | The LIAISON® Anti-HAV assay is an in vitrochemiluminescent immunoassay intended forthe qualitative detection of total antibodies tohepatitis A (anti-HAV) in human serum andsodium heparin plasma samples using theLIAISON® Analyzer family. The assay isindicated as an aid in the laboratory diagnosisof current or previous HAV infections inconjunction with other serological and clinicalinformation and to determine the presence of anantibody response to HAV in vaccinerecipients.This assay is not intended for screening bloodor solid or soft tissue donors. | Same |
| Principles of operation | Chemiluminescence using magnetic particlesolid phase and chemiluminescent tracer | Same |
| Optical System | High-sensitive, low-noise photomultiplier tube(PMT) operating as an ultra-fast photoncounter. Pulses are amplified by a rapidelectronic amplifier.Circuit that suppresses PMT signal noise.Linear measuring range = 300 - 650 nmLight peak of chemiluminescence emitted at450 nm | Same |
| Temperature Control: Reaction Temperature | 36°C±1°C | Same |
| Temperature Control: Reagent StorageTemperature | 11-15°C | Same |
| Dispense System | Automated pipetting of samples and reagents.Left pipetting unit used for samples; rightpipetting unit used for reagents.Sample pipetting: disposable tipPrecision syringesLeft pipetting unit operates an air displacementsyringe.Right pipetting unit operates a liquid filledsyringe.Sample Probe (disposable tip):Liquid Level Detection and ClotDetection feature (pressure)Disposable tips: 2 trays of 96 tips each can beloaded on board.Monitored through software counter andpresence sensor upon tip pick-up.Reloading allowed before run, or pausing theongoing tasks during a routine.Reagent Probe | Same |
| Liquid Level Detection (capacitive),with software tracking of reagentlevelOptical Liquid Verification (real-timemonitoring of liquid flow inside theprobe) | ||
| Sample Handling | Capacity: Holds 4 sample racks, 12 places perrack | Same |
| Tube types:- primary tube- aliquot tube- pediatric | Same | |
| Sample presence, sample type (calibrator,control, patient), tube size, and processingcompletion tracked by operating software andsample barcode | Same | |
| Reagent Handling | Capacity: 10 Reagent Integrals (RI), plus 4positions for Ancillary Reagents | Same |
| RI contains all reagents required for any givenassay (up to 7 vials per RI, first vial alwayscontains magnetic particles). | Same | |
| Assay-specific processing and analysisparameters, calibration, lot number, expirationdate, and usage (number of tests run) arecontrolled by operating software ascommunicated by RF-Tag (RF-ID). | Same | |
| Additional Reagents | Control Set (2 or more levels) LIAISON Light Check (diagnostic toolonly, reserved for service intervention) LIAISON® EASY Starter Kit (StarterReagents 1 and 2, with different tradename, but the same formulation as LiaisonStarter Kit) LIAISON® EASY Wash/System Liquid(used as a wash liquid – immunometricwash step and fluidic filler) LIAISON® EASY Cleaning Tool. | Control Set (2 levels) LIAISON Light Check (diagnostic toolonly, reserved for service intervention) LIAISON EASY Starter Kit (StarterReagents 1 and 2, with different tradename, but the same formulation as LiaisonStarter Kit) LIAISON® EASY Wash Buffer (used asa wash liquid - immunometric wash step -, with different trade name, but the sameformulation as LIAISON® EASY Wash/System Liquid) LIAISON® EASY System Liquid (usedas a fluidic filler and cleaner of thereagent needle) LIAISON® EASY Cleaning Tool. |
| In addition:Purified water is also required as SystemLiquid, as fluidic filler and to perform:- reagent needle cleaning- washer needle cleaning A cleaning tank is available to host acleaning liquid suitable for automatedmaintenance purpose | In addition:No purified water is used A cleaning tank is available to host acleaning liquid suitable for automatedmaintenance purpose | |
| Level sensor present | Level sensor present as a capacitive rod | |
| Starter reagents | The system can host one set of StarterReagents.Recognition of Starter Reagents: via RF-Tag | Same |
| One bottle of each Starter reagent can be loadedon board | Same | |
| Injection of Starter Reagents through highprecision/accuracy pump (fixed dispensingvolume) | Same | |
| dispense monitoring through optical sensorinjection 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 theongoing 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 laboratoriesData exchange for Reagent Integrals,• Ancillary Reagents, Starter Reagents via RF-ID technology: higher data exchange, higher reagent traceability allowedDisposable 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 LiquidChanges 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 criteriamet? |
|---|---|---|---|
| Analytical Sensitivity, asconcentration at cut off thresholdvs WHO standard preparation | Analytical sensitivity in the range15.5 - 21.5 mIU/ml | Run 1: 21 mIU/mLRun 2: 20 mIU/mL | Yes |
| Total precision, as value of thepercentage coefficient ofvariation (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.
§ 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.