(86 days)
Not Found
No
The summary describes a chemiluminescent immunoassay system and its components, focusing on automated sample handling, reagent processing, and detection. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is described as an in vitro diagnostic assay and analyzer used for detecting antibodies, which aids in diagnosis and monitoring, and does not directly treat or cure a disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that 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".
No
The device description clearly outlines hardware components such as loading areas, incubator, wash station, reader, and barcode reader, indicating it is a physical analyzer, 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" and the LIAISON® XL Analyzer is an "automated discrete continuous loading chemiluminescent immunoassay (CLIA) analyzer for in vitro diagnostic analysis of CLIAs on human specimens".
- Device Description: The "Device Description" section also refers to the LIAISON® XL Analyzer as an "in vitro diagnostic device".
- Purpose: The assay is intended for the qualitative detection of antibodies in human serum and plasma samples to aid in the diagnosis of HAV infections and determine antibody response to vaccines. This is a classic application of in vitro diagnostics.
- Regulatory Language: The "Caution: U.S. Federal Law restricts this device to sale by or on the order of a physician" is also a common indicator of a regulated medical device, including IVDs.
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 specimens cleared for use on the analyzer. It is only to be used with FDA cleared chemiluminescent immunoassays that are marketed by DiaSorin for the LIAISON® XL Analyzer. The analyzer can be connected to a third party Laboratory Automation System (LAS) which has been previously cleared for use with FDA cleared assays.
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® XL and LIAISON® XL with LIAISON® XL Workcell Upgrade Kit.
Product codes
LOL, JJF
Device Description
The LIAISON® XL Analyzer is an in vitro diagnostic device consisting of loading areas (for samples, Reagent Integrals, ancillary reagents, Starter Reagents, Cuvettes, Disposable Tips, water, Wash Buffer, maintenance liquid); incubator, wash station, reader, and a barcode reader for reagents and samples. Installation of the LIAISON® XL Workcell Upgrade Kit allows the LIAISON® XL Analyzer to be used with a compatible LAS and extends the sample pipetting capabilities to a point-in-space located external to the analyzer.
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)
The results from the non-clinical studies submitted in this premarket notification demonstrate that the LIAISON® XL Workcell Upgrade Kit is substantially equivalent to the predicate device.
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
KC141116
JUL 2 5 2014
510(k) SUMMARY
SUBMITTED BY:
Mari Mever Director, Regulatory Affairs DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 Phone (651) 439-9710 Fax (651) 351-5669 Email: mari.meyer@diasorin.com
NAME OF DEVICE:
Trade Name:
Common Names/Descriptions:
Regulation Number:
Requlation Name:
Regulation Class:
Product Codes:
PREDICATE DEVICES:
LIASON® Anti-HAV, LIAISON® XL Analyzer
Hepatitis Anti-HAV, serological assay, Automated Chemiluminescent Immunoassay Analyzer
21 CFR 866.3310
Hepatitis A virus (HAV) serological assays
Class II
LOL. JJF
LIAISON® XL Analyzer Reference K103529
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. Section 5
1
DiaSorin LIAISON® XL Workcell Upgrade Kit
- The LIAISON XL Analyzer is an automated discrete continuous loading chemiluminescent immunoassay (CLIA) analyzer for in vitro diagnostic analysis of CLIAs on human specimens cleared for use on the analyzer. It is only to be used with FDA cleared chemiluminescent immunoassays that are marketed by DiaSorin for the LIAISON XL Analyzer. The analyzer can be connected to a third party Laboratory Automation System (LAS) which has been previously cleared for use with FDA cleared assavs.
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® LIAISON® XL and LIAISON® XL with LIAISON® XL Workcell Upgrade Kit.
DESCRIPTION:
The LIAISON® XL Analyzer is an in vitro diagnostic device consisting of loading areas (for samples, Reagent Integrals, ancillary reagents, Starter Reagents, Cuvettes, Disposable Tips, water, Wash Buffer, maintenance liquid); incubator, wash station, reader, and a barcode reader for reagents and samples. Installation of the LIAISON® XL Workcell Upgrade Kit allows the LIAISON® XL Analyzer to be used with a compatible LAS and extends the sample pipetting capabilities to a point-in-space located external to the analyzer.
COMPARISON TO PREDICATE DEVICE:
The following table compares the LIAISON® XL Analyzer to the LIAISON® XL Workcell Upgrade Kit.
2
| Summary of Device Similarities and Differences: | ||
|---|---|---|
| Characteristic | Predicate Device | |
| LIAISON® XL analyzer | New Device: LIAISON® XL with LIAISON® | |
| XL Workcell Upgrade Kit | ||
| FDA k# | K103529 | K141116 |
| 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. | 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 XL Analyzer is an automated
discrete continuous loading chemiluminescent
immunoassay (CLIA) analyzer for in vitro
diagnostic analysis of CLIAs on human
specimens cleared for use on the analyzer. It is
only to be used with FDA cleared
chemiluminescent immunoassays that are
marketed by DiaSorin for the LIAISON XL
Analyzer. The analyzer can be connected to a
third party Laboratory Automation System
(LAS) which has been previously cleared for
use with FDA cleared assays. |
| | 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 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®, LIAISON® XL and LIAISON® XL
with LIAISON® XL Workcell Upgrade Kit. |
| Principles of
Operation | Chemiluminescence using magnetic particle
solid phase and chemiluminescent tracer | Same |
| Characteristic | Predicate Device
LIAISON® XL analyzer | New Device: LIAISON® XL with LIAISON®
XL Workcell Upgrade Kit |
| FDA k# | K103529 | K141116 |
| 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
Reagent Storage Temperature: 11-15°C | Same |
| Dispense
System | Automated pipetting of samples and
reagents;
Left pipetting unit used for samples
(using disposable tip);
Right pipetting unit used for reagents
(metal needle); | Same |
| | Precision syringes (sample and reagent)
Sample Probe (disposable tip):
Liquid Level Detection and Clot
Detection feature (pressure)
Disposable tips: 6 trays of 96 tips each
can be loaded on board.
Monitored through software counter and
presence sensor upon tip pick-up.
Re-loading allowed during run | Same |
Summary of Device Similarities and Differences:
.
3
DiaSorin | IAISON® XL Workcell Un de Kit
| Characteristic | Predicate Device
LIAISON® XL analyzer | New Device: LIAISON® XL with
LIAISON® XL Workcell Upgrade Kit |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| | Reagent Probe:
• Liquid Level Detection (capacitive), with
software tracking of reagent level
• Optical Liquid Verification (real-time
monitoring of liquid flow inside the
probe) | Same |
| Sample Handling | Capacity:
• Holds 10 sample racks,
• 12 places per rack | Same (in the stand alone mode) |
| | 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 bar-code | Same (in the stand alone mode) |
| Test Orders | From LIS or middleware to analyzer | Same |
| Test Results | To LIS or middleware from analyzer | Same |
| Reagent Handling | Capacity: 25 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 |
4
| DiaSorin LIAISON® XL Workcell Upgrade Kit | ||
|---|---|---|
| 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 | Same | |
| 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 (used as a wash liquid only – immunometric wash step) 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 | Same |
| Starter Reagents | Level sensing by capacitive rod | Same |
| Recognition of Starter Reagents via RF-Tag | Same | |
| Two bottles 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 | Same | |
| Injection of Starter Reagents occurs at | ||
| controlled temperature (33-37°C) | Same |
5
| Characteristic | Predicate Device
LIAISON® XL analyzer | LIAISON® XL Workcell Upgrade Kit |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reaction Modules | Single-cavity Cuvettes
Storage capacity: >600 Cuvettes
Inventory monitoring through software counter.
Sensors detect actual presence of Cuvettes
Reloading allowed during run
Unloading automatic into waste bag | Same
Same
Same
Same
Same
Same |
| Test Processing | Random Access and Batch
Continuous operation
Sample scheduling optimized throughput process | Same
Same
Same |
| Assay Protocols | 1-Step assays: 1 incubation sequence / 1 wash sequence; average incubation time = 10 minutes
2-Step assays: 2 incubation sequence / 1 or 2 wash sequence(s); average incubation time = 10 minutes
Two-point calibration of assays | Same
Same
Same |
| Human Interface | Computer
Touch-screen On Screen Keyboard (keyboard and mouse not supplied)
Monitor – touch screen, color
Printer
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
Same
Same
Same
Same
(in the stand alone mode)
Same |
| Data Analysis | Automated data reduction
Assay-specific Master Curve with 2-point recalibration
Assay-specific data reduction | Same
Same
Same |
| QC Software | Stored lot-specific control results
Lot-specific Levey-Jennings plotting
Trend identification
Statistical analyses | Same
Same
Same
Same |
| Specimens | Serum or plasma
Sampling from primary, aliquot, or pediatric tubes | Same
Same |
| Disposables | Reagent Integrals
Light Check (diagnostic tool)
Starter Kit
Wash/System Liquid
Cuvettes
Disposable Tips
Waste Bag | Same
Same
Same
Same
Same
Same
Same |
| Software | Based on: Windows Vista
· Software controlling the analyzer with Graphical User Interface (v4.0.0.4 sp3)
· LAS interface disabled | Same
· Same
· LAS interface enabled |
| Characteristic | Predicate Device | LIAISON® XL Workcell Upgrade Kit |
| | LIAISON® XL analyzer | |
| General Operation | The Cuvette sorting mechanism feeds the
incubator, in order to have all vacant
incubator positions (i.e. 80 incubation
slots) always full of Cuvettes available for
new pipetting tasks. Pipetting of sample
and reagents occurs within the incubator. | Same |
| General Operation | Incubator rotates (CW/CCW) in order to
bring the appropriate Cuvette to one of the
3 dedicated pipetting positions. At the end
of the incubation time, the incubator-
washer pusher transports the Cuvette
from its position in the incubator into the
washer. The washer transport
mechanism (spindle) moves the Cuvettes
present in the washer channel one cavity
position at a time, using half of the
analyzer time cycle, from one washing
station to the next. Each of the 6 washer
needles accesses a Cavity only once.
Upon completion of the wash step, the
following two situations may apply:
CASE 1: Return transport for 2-step
process.
The washer- incubator pusher moves the
Cuvette back into the incubator (in a vacant
incubator slot) for addition of second-step
reagent(s). After incubation, the Cuvette
goes through the washer again.
CASE 2: Transport into the measuring
chamber.
The washer transport mechanism (spindle)
moves the Cuvette to the measuring
chamber.
After the measurement, the reaction
solution is removed by suction and the
Cuvette then is transported out of the
measuring chamber and into the solid waste
bin. | Same |
| | | |
| Characteristic | Predicate: LIASON XL Analyzer
K103529
LIAISON® XL | New Device: LIASON XL with LIASON XL
Workcell Upgrade Kit
K141116 |
| Sample Aspiration | Directly from sample tube in the
sample bay of the analyzer | Directly from sample tube in the
sample bay of the analyzer (in the
stand alone mode) and Directly from sample tube presented
by the Workcell to the aspiration point-
in-space position at the analyzer
interface (in LAS mode) |
| Sample Identification
from bar-coded tubes | Bar-coded sample tubes (mono
dimension barcode) read directly by
analyzer bar code reader | Bar-coded sample tubes (mono
dimension barcode) read directly by
analyzer bar code reader (stand-
alone mode) and Bar-coded sample tubes (mono
dimension barcode) read by Workcell
barcode scanner. |
| LAS Communication | N/A | LIAISON® XL software communicates with
Workcell via LAS interface communication
protocol |
6
. .
. . . . . . . .
.
:
.
7
Table 2: Differences
CONCLUSION:
The results from the non-clinical studies submitted in this premarket notification demonstrate that the LIAISON® XL Workcell Upgrade Kit is substantially equivalent to the predicate device.
.
8
Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2014
DIASORIN, INC. MARI MEYER DIRECTOR, REGULATORY AFFAIRS 1951 NORTHWESTERN AVE. P.O. BOX 285 STILLWATER MN 55082-0285
Re: K141116
Trade/Device Name: LIAISON XL Analyzer with LIAISON XL Workcell Upgrade Kit Regulation Number: 21 CFR 866.3310 Regulation Name: Hepatitis A virus (HAV) serological assays Regulatory Class: II Product Code: LOL, JJF Dated: April 29, 2014 Received: April 30, 2014
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, 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
9
Page 2-Ms. Meyer
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Stephen J. Lovell -S for
Sally Hojvat. M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
10
Indications for Use
510(k) Number (if known) K141116
Device Name LIAISON XL Analyzer
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 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 specimens cleared for use on the analyzer. It is only to be used with FDA cleared chemiluminescent immunoassays that are marketed by DiaSorin for the LIAISON® XL Analyzer. The analyzer can be connected to a third party Laboratory Automation System (LAS) which has been previously cleared for use with FDA cleared assays.
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® XL and LIAISON® XL with LIAISON® XL Workcell Upgrade Kit.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
Stephen J. Lovell -S 2014.07.24 13:38:59 -04'00'
11
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