(51 days)
Not Found
No
The description details a standard automated chemiluminescent immunoassay analyzer and assay, with no mention of AI or ML algorithms for data analysis, interpretation, or system control.
No
The device is an in vitro diagnostic immunoassay system used to detect antibodies to hepatitis A. It provides diagnostic information but does not treat or prevent any medical condition.
Yes
The "Intended Use / Indications for Use" states that the LIAISON® Anti-HAV assay is "intended for the qualitative detection of total antibodies to hepatitis A (anti-HAV) in human serum and sodium heparin plasma samples" and is "indicated as an aid in the laboratory diagnosis of current or previous HAV infections."
No
The device description explicitly details a chemiluminescent immunoassay analyzer (LIAISON® XL Analyzer) which is a piece of hardware used for in vitro diagnostic analysis. The software is part of the overall system but the device itself is 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 in human serum and sodium heparin plasma samples. It also mentions its use as an aid in the laboratory diagnosis of current or previous HAV infections and to determine antibody response in vaccine recipients.
- Device Description: The "Device Description" section describes the LIAISON® XL Analyzer as an automated discrete continuous loading chemiluminescent immunoassay (CLIA) analyzer for in vitro diagnostic analysis of CLIAs on human serum or plasma.
- Regulatory Language: The statement "Caution: U.S. Federal Law restricts this device to sale by or on the order of a physician" is common language used for devices regulated as IVDs.
- Predicate Device: The mention of "Predicate Device(s)" with K numbers (K032844/K082050) and the name "LIAISON® Analyzer" indicates that this device has gone through a regulatory clearance process, which is typical for IVDs.
All of these points clearly indicate that the LIAISON® Anti-HAV assay and the associated LIAISON® XL Analyzer are intended for use in a laboratory setting to perform diagnostic tests on samples taken from the human body, which is 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. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. The user is responsible for establishing assay performance characteristics in these populations. Caution: U.S. Federal Law restricts this device to sale by or on the order of a physician.
The LIAISON® XL Analyzer is an automated discrete continuous loading chemiluminescent immunoassay (CLIA) analyzer for in vitro diagnostic analysis of CLIAs on human serum or plasma. The system menu includes infectious disease, bone and mineral, and endocrinology CLIAs. It is to be used only with FDA cleared chemiluminescence immunoassays that are marketed by DiaSorin for the LIAISON XL Analyzer.
The LIAISON® Control Anti-HAV (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Anti-HAV assay.
The performance characteristics of LIAISON® controls have not been established for any other assays or instrument platforms different from LIAISON® and LIAISON® XL.
Product codes
LOL, JJF
Device Description
The LIAISON® XL Analyzer is an automated discrete continuous loading chemiluminescent immunoassay (CLIA) analyzer for in vitro diagnostic analysis of CLIAs on human serum or plasma. The system menu includes infectious disease, bone and mineral, and endocrinology CLIAs. It is to be used only with FDA cleared chemiluminescence immunoassays that are marketed by DiaSorin for the LIAISON XL Analyzer.
The LIAISON® Control Anti-HAV (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Anti-HAV assay.
The performance characteristics of LIAISON® controls have not been established for any other assays or instrument platforms different from LIAISON® and LIAISON® XL.
The method for qualitative determination of anti-HAV is a competitive sandwich chemiluminescence immunoassay (CLIA) based on neutralization. Antibodies to HAV (mouse monoclonal) are used for coating magnetic particles (solid phase) and are linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, 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. During the second incubation, the antibody conjugate and the solid-phase antibody compete with anti-HAV present in the specimen for HAV, that allows the conjugate to bind to the solid phase and thus form a "sandwich" of conjugate antibody-antigen-solid phase antibody. If all HAV added is sequestered in an HAVanti-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
The LIAISON® XL Analyzer is an automated discrete continuous loading chemiluminescent immunoassay analyzer for in vitro diagnostic use.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
DiaSorin LIAISON® XL Analyzer Premarket Notification
5.0 510(k) SUMMARY
SUBMITTED BY:
JAN 2 1 2011
Mari Mever Senior Manager, Regulatory/Clinical Affairs DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 Phone (651) 351-5635 Fax (651) 351-5669 Email: mari.mever@diasorin.com
NAME OF DEVICE:
| Trade Name: | LIAISON® Anti-HAV, LIAISON® XL Analyzer |
|---|---|
| Common Names/Descriptions: | Hepatitis Anti-HAV, serological assay, Automated Chemiluminescent Immunoassay Analyzer |
| Regulation Number: | 21 CFR 866.3310 |
| Regulation Name: | Hepatitis A virus (HAV) serological assays |
| Regulatory Class: | Class II |
| Product Code: | LOL, JJF |
| PREDICATE DEVICES: | LIAISON® Analyzer Reference K082050 |
DEVICE DESCRIPTION:
INTENDED USE:
The LIAISON® Anti-HAV assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of total antibodies to hepatitis A (anti-HAV) in human serum and sodium heparin plasma samples using the LIAISON® Analyzer family. The assay is indicated as an aid in the laboratory diagnosis of current or previous HAV infections in conjunction with other serological and clinical information and to determine the presence of an antibody response to HAV in vaccine recipients.
This assay is not intended for screening blood or solid or soft tissue donors. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. The user is responsible for establishing assay performance characteristics in these populations. Caution: U.S. Federal Law restricts this device to sale by or on the order of a physician.
1
The LIAISON® XL Analyzer is an automated discrete continuous loading chemiluminescent immunoassay (CLIA) analyzer for in vitro diagnostic analysis of CLIAs on human serum or plasma. The system menu includes infectious disease, bone and mineral, and endocrinology CLIAs. It is to be used only with FDA cleared chemiluminescence immunoassays that are marketed by DiaSorin for the LIAISON XL Analyzer.
The LIAISON® Control Anti-HAV (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Anti-HAV assay.
The performance characteristics of LIAISON® controls have not been established for any other assays or instrument platforms different from LIAISON® and LIAISON® XL.
DESCRIPTION:
The method for qualitative determination of anti-HAV is a competitive sandwich chemiluminescence immunoassay (CLIA) based on neutralization. Antibodies to HAV (mouse monoclonal) are used for coating magnetic particles (solid phase) and are linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, 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. During the second incubation, the antibody conjugate and the solid-phase antibody compete with anti-HAV present in the specimen for HAV, that allows the conjugate to bind to the solid phase and thus form a "sandwich" of conjugate antibody-antigen-solid phase antibody. If all HAV added is sequestered in an HAVanti-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 isoluminolantibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is inversely indicative of anti-HAV present in calibrators, samples or controls
The LIAISON® XL Analyzer is an automated discrete continuous loading chemiluminescent immunoassay analyzer for in vitro diagnostic use.
2
.
COMPARISON TO PREDICATE DEVICE:
The following table compares the LIAISON® XL Analyzer to the LIAISON® Analyzer.
| Feature | Summary of Device Similarities and Differences:
LIAISON® Analyzer | LIAISON® XL Analyzer |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA K# | K032844/K082050 | N/A |
| Intended Use | Automated chemiluminescent analyzer for clinical use | 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. | 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
Temperature | $36°C±1°C$ | $36°C±1°C$ |
| • Reagent Storage
Temperature | 12-19°C | 11-15°C |
| Dispense System | Automated pipetting of samples and
reagents. Left pipetting unit used for
samples; right pipetting unit used for
reagents | same
(sample pipetting: disposable tip) |
| | Precision syringes (sample and reagent) | same |
| | Sample Probe:
• Liquid Level Detection
(capacitive)
• Clot Detection feature
(software algorithm based on
capacitive signal) | Sample Probe (disposable tip):
• Liquid Level Detection and
• Clot Detection feature
(pressure) |
| | N/A | Disposable tips: 6 trays of 96 tips
each can be loaded on board.
Monitored through software
counter and presence sensor
upon tip pick-up.
Reloading allowed during run |
| | Reagent Probes:
• Liquid Level Detection
(capacitive), with software
tracking of reagent level | Reagent Probes:
• Liquid Level Detection
(capacitive), with software
tracking of reagent level
• Optical Liquid Verification
(real-time monitoring of
liquid flow inside the
probe) |
| Feature | LIAISON® Analyzer | LIAISON® XL Analyzer |
| Sample Handling | Capacity: Holds 12 sample racks, 12
places per rack
Tube types:
- primary tube
- aliquot tube
- pediatric
Sample presence, sample type
(calibrator, control, patient), tube size,
and processing completion tracked by
operating software and sample
barcode | Capacity: Holds 10 sample racks,
12 places per rack
same
same |
| Reagent Handling | Capacity: 15 Reagent Integrals (RI)
RI contains all reagents required for
any given assay (up to 7 vials per RI,
first always contains magnetic
particles).
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 barcode. | Capacity: 25 Reagent Integrals
(RI), plus 4 positions for Ancillary
Reagents
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). |
| Additional Reagents | • Control Set (2-3 levels)
• LIAISON Light Check (diagnostic
tool only)
• LIAISON Starter Kit (Starter
Reagents 1 and 2)
• LIAISON Wash/System Liquid
• LIAISON Cleaning Kit | • Control Set (2-3 levels)
• LIAISON Light Check
(diagnostic tool only)
• LIAISON Starter Kit (Starter
Reagents 1 and 2)
• LIAISON Wash/System
Liquid (used as a wash liquid
only - immunometric wash
step)
• LIAISON Cleaning Kit
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 |
| | Level sensing by capacitive rod | same |
| Reaction Modules | Capacity: 6 individual reaction
compartments per Reaction Module
Storage capacity: maximum 120
strips stored in LIAISON stacker | Single-cavity Cuvettes
Storage capacity: >600 Cuvettes |
| Feature | LIAISON® Analyzer | LIAISON® XL Analyzer |
| Reaction Modules (cont.) | Sensors detect presence of Reaction
Modules, and loading and occupancy
of stacker. | Inventory monitoring through
software counter.
Sensors detect actual presence
of Cuvettes |
| | Reloading allowed during run | same |
| Test Processing | Unloading automatic into waste bag
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 calibration of assays | same |
| Human Interface | Computer Mouse and keyboard | Touch-screen On Screen
Keyboard |
| | Monitor - touch screen, color Printer Stationary barcode scanners for
identification of samples and
reagents | same Printer (optional) 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 |
| | Computer LIS Interface | same |
| Data Analysis | Automated data reduction | same |
| | Assay-specific Master Curve with 2-
point recalibration | same |
| | Assay-specific data reduction | same |
| QC Software | Stored lot-specific control results | same |
| | Lot-specific Levey-Jennings plotting | same |
| | Trend identification | same |
| | Statistical analyses | same |
| Specimens | Serum or plasma | same |
| | Sampling from primary, aliquot, or
pediatric tubes | same |
| Disposables | Reagent Integrals Light Check (diagnostic tool) Starter Kit Wash/System Liquid Reaction Modules | same |
| | N/A | Cuvettes Disposable Tips |
| | Waste Bag Cleaning Kit | same (dedicated) |
| Feature | LIAISON® Analyzer | LIAISON® XL Analyzer |
| Hardware Improvements | LIAISON® Analyzer | LIAISON® Analyzer, with enhancements as follows:
floor-standing, integrated design improved average throughput, Improved data exchange for Reagent Integrals, Ancillary Reagents, Starter Reagents via RF-ID technology Disposable tip for sample pipetting Continuous loading of all liquid and solid resources or waste Increased liquid/reagent capacity Increased efficiency of washer needle cleaning Automated Maintenance tasks On-line help: User Manual and Quick Guide directly accessible on screen |
Summary of Device Similarities and Differences:
3
4
5
CONCLUSION:
The material submitted in this premarket notification is complete and supports the substantial equivalence of the LIAISON® XL Analyzer to the predicate device.
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
DiaSorin, Inc. Attn: Mari Meyer 1951 Northwestern Ave. P.O. Box 285 Stillwater, MN 55082
JAN 2 1 201
Re: K103529
Trade/Device Name: LIAISON Anti-HAV, LIAISON XL Analyzer Regulation Number: 21 CFR 866.3310 Regulation Name: Hepatitis A virus (HAV) serological assays Regulatory Class: Class II Product Code: LOL, JJF Dated: November 30, 2010 Received: December 1, 2010
Dear Ms. Meyer:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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
Commission of the
Section of the country of the county
.
7
Page 2 - Mari Meyer
CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Vacayartyr
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): K103529
LIAISON® Anti-HAV, LIAISON® XL Analyzer Device Name:
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. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. The user is responsible for establishing assay performance characteristics in these populations. Caution: U.S. Federal Law restricts this device to sale by or on the order of a physician.
The LIAISON® XL Analyzer is an automated discrete continuous loading chemiluminescent immunoassay (CLIA) analyzer for in vitro diagnostic analysis of CLIAs on human serum or plasma. The system menu includes infectious disease, bone and mineral, and endocrinology CLIAs. It is to be used only with FDA cleared chemilyminescence immunoassays that are marketed by DiaSorin for the LIAISON XL Analyzer.
The LIAISON® Control Anti-HAV (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Anti-HAV assay.
The performance characteristics of LIAISON® controls have not been established for any other assays or instrument platforms different from LIAISON® and LIAISON® XL.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Uhe Gey
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k 103529
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