(170 days)
PMA #P890014
Not Found
No
The device description and performance studies focus on a standard chemiluminescent immunoassay and do not mention any AI or ML components.
No
The device is an in vitro diagnostic immunoassay that qualitatively detects antibodies to hepatitis A virus to aid in diagnosis, not to provide therapy.
Yes
The LIAISON® HAV IgM assay detects IgM antibodies to hepatitis A virus, and the results, in conjunction with other information, are used as an "aid in the laboratory diagnosis of acute or recent HAV infection." This directly indicates its role in diagnosing a medical condition.
No
The device description clearly outlines a chemiluminescent immunoassay (CLIA) method involving magnetic particles, antibodies, and a photomultiplier to measure light signals. This indicates a physical, hardware-based system for performing the assay, not a software-only device.
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® HAV IgM assay is an "in vitro chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to hepatitis A virus (IgM anti-HAV) in human serum and plasma". This clearly indicates that the device is used outside of the body to analyze biological samples for diagnostic purposes.
- Device Description: The description details a laboratory-based assay method (antibody capture chemiluminescence immunoassay) that involves analyzing human serum and plasma samples.
- Performance Studies: The document describes performance studies conducted on human samples (seroconversion panels, serum, and plasma) to evaluate the assay's performance characteristics, which is typical for IVD devices.
- Predicate Device: The mention of a "Predicate Device(s)" with a PMA number (P890014) further confirms that this device is being compared to a previously approved IVD.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LIAISON® HAV IgM assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to hepatitis A virus (IgM anti-HAV) in human serum and plasma (sodium citrate, potassium EDTA, lithium and sodium heparin, and citrate dextrose (ACD)) using the LIAISON® Analyzer. Assay results, in conjunction with other serological and clinical information, may be used for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis as an aid in the laboratory diagnosis of acute or recent HAV infection. 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 their own assay performance characteristics in these populations.
The LIAISON® Control HAV IgM (negative and positive) are intended for use as assayed quality control samples to monitor the performance of the LIAISON® HAV IgM assay.
Product codes (comma separated list FDA assigned to the subject device)
LOL, JJX
Device Description
The method for qualitative determination of HAV IgM is an antibody capture chemiluminescence immunoassay (CLIA).
lgG to human IgM (mouse monoclonal) is used for coating magnetic particles (solid phase) and a mouse monoclonal antibody to HAV is linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, IgM antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with HAV antigen just added and the immune complex thus formed reacts with IgM already bound to the solid phase. After each 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 indicative of anti-HAV IgM present in calibrators, samples or controls.
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)
COMPARATIVE STUDIES:
Five commercially available HAV seroconversion panels were tested using the LIAISON® HAV IgM and the FDA-approved comparator assay to determine sensitivity of the assay. The sensitivity of the LIAISON® HAV IgM was equivalent to the comparator assay in the five seroconversion panels tested.
REPRODUCIBILITY:
A 5 day reproducibility/precision study was conducted at three external laboratories. The CLSI document EP15-A3 was consulted in the preparation of the testing protocol. A coded panel comprised of 6 frozen serum samples was prepared by DiaSorin S.p.A. The coded panel was prepared by either spiking or diluting samples as necessary to contain negative, low positive and mid positive samples.
The LIAISON® Control HAV IgM (negative and positive) were also included in the 5 day study. The LIAISON® HAV IgM Negative Control as well as negative panel sample (HAVM-P00) read below the detectable limit of the curve
§ 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.
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Image /page/0/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 three human profiles facing to the right, stacked on top of each other.
August 25, 2016
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Public Health Service
DiaSorin, Inc. Carol A. DePouw Regulatory Affairs Specialist 1951 Northwestern Avenue Stillwater, MN 55082-0285
Re: K160650
Trade/Device Name: LIAISON® HAV IgM and LIAISON® Control HAV IgM Regulation Number: 21 CFR 866.3310 Regulation Name: Hepatitis A virus (HAV) serological assays Regulatory Class: II Product Code: LOL, JJX Dated: July 27, 2016 Received: July 28, 2016
Dear Ms. DePouw:
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.
1
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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Steven R. Gitterman -S
for Uwe Scherf M. Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160650
Device Name LIAISON® HAV IgM Assay LIAISON® Control HAV IgM
Indications for Use (Describe)
The LIAISON® HAV IgM assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to hepatitis A virus (IgM anti-HAV) in human serum and plasma (sodium citrate, potassium EDTA, lithium and sodium heparin, and citrate dextrose (ACD)) using the LIAISON® Analyzer. Assay results, in conjunction with other serological and clinical information, may be used for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis as an aid in the laboratory diagnosis of acute or recent HAV infection. 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 their own assay performance characteristics in these populations.
The LIAISON® Control HAV IgM (negative and positive) are intended for use as assayed quality control samples to monitor the performance of the LIAISON® HAV IgM assay.
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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5.0 510(k) SUMMARY
| SUBMITTED BY: | Carol A. DePouw
Regulatory Affairs Specialist
DiaSorin Inc.
1951 Northwestern Avenue
Stillwater, MN 55082-0285
Phone (651) 351-5850
Fax (651) 351-5669
Email: carol.depouw@diasorin.com |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NAME OF DEVICE: | |
| Trade Name: | LIAISON® HAV IgM,
LIAISON® Control HAV IgM |
| Common Names/Descriptions: | Hepatitis A Test (Antibody and IgM Antibody)
and Controls |
| Classification Names: | Hepatitis A Virus (HAV) Serological assays
21 CFR 866.3310 Class II Special Controls
Microbiology
Single (Specified) analyte controls (assayed
and unassayed); Class I reserved;
21 CFR 862.1660: Clinical Chemistry |
| Product Code: | LOL, JJX |
| PREDICATE DEVICES | DiaSorin Inc. ETI-HA-IGMK Plus Kit
(PMA #P890014) |
DEVICE DESCRIPTION:
INTENDED USE:
The LIAISON® HAV IqM assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to hepatitis A virus (IgM anti-HAV) in human serum and plasma (sodium citrate, potassium EDTA, lithium and sodium heparin and citrate dextrose (ACD)) using the LIAISON® Analyzer. Assay results, in conjunction with other serological and clinical information, may be used for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis as an aid in the laboratory diagnosis of acute or recent HAV infection.
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 their own assay performance characteristics in these populations.
4
The LIAISON® Control HAV IgM (negative and positive) are intended for use as assayed quality control samples to monitor the performance of the LIAISON® HAV laM assav.
The method for qualitative determination of HAV IgM is an KIT DESCRIPTION: antibody capture chemiluminescence immunoassay (CLIA).
lgG to human IgM (mouse monoclonal) is used for coating magnetic particles (solid phase) and a mouse monoclonal antibody to HAV is linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, IgM antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with HAV antigen just added and the immune complex thus formed reacts with IgM already bound to the solid phase. After each 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 indicative of anti-HAV IgM present in calibrators, samples or controls.
REASON FOR SUBMISSION:
The purpose of this 510(k) Submission is to present the proposed modifications to the DiaSorin LIAISON® HAV IgM and the LIAISON® Control HAV IgM (K082050).
Description of modifications to the LIAISON® HAV IgM and the LIAISON® Control HAV IgM:
-
Proprietary changes to the monoclonal antibodies and conjuqate.
-
Extension of stability claims for the calibration curve, on-board and open use storage.
-
- Addition of sample types and sample stabilities.
-
- Change from buffer based controls to serum based controls.
PERFORMANCE DATA:
The following studies were conducted to demonstrate that the modifications to the LIAISON® HAV IgM assay confirm the substantial equivalence to the predicate device and raise no new questions of safety and effectiveness. Studies not pertaining to the modifications may be found in the original 510(k) K082050.
COMPARATIVE STUDIES:
Five commercially available HAV seroconversion panels were tested using the LIAISON® HAV IgM and the FDA-approved comparator assay to determine sensitivity of the assay. The results are summarized in Table 1.
5
| Panel ID | LIAISON® HAV IgM | | Comparator Assay | | Difference
in days
from last
reactive
result |
|--------------------------|--------------------------------------------------------|-------------------------------------------------|--------------------------------------------------------|-------------------------------------------------|----------------------------------------------------------|
| | Post-bleed
day of
earliest
reactive
result | Post-bleed
day of last
reactive
result | Post-bleed
day of
earliest
reactive
result | Post-bleed
day of last
reactive
result | |
| 0615-0026 seroconversion | 14 | 27 | 14 | 27 | 0 |
| PHT902 seroconversion | 16 | 21 | 16 | 21 | 0 |
| PHT903 seroconversion | 38 | 108 | 38 | 108 | 0 |
| RP004 seroconversion | 6 | 62 | 6 | 62 | 0 |
| RP013 seroconversion | 8 | 189 | 8 | 189 | 0 |
Table 1
The sensitivity of the LIAISON® HAV IgM was equivalent to the comparator assay in the five seroconversion panels tested.
REPRODUCIBILITY:
A 5 day reproducibility/precision study was conducted at three external laboratories. The CLSI document EP15-A3 was consulted in the preparation of the testing protocol. A coded panel comprised of 6 frozen serum samples was prepared by DiaSorin S.p.A. The coded panel was prepared by either spiking or diluting samples as necessary to contain negative, low positive and mid positive samples.
| The LIAISON® Control HAV IgM (negative and positive) were also included in the 5 day study. The LIAISON® HAV IgM Negative Control as well as negative panel sample (HAVM-P00) read below the detectable limit of the curve Specimen | |
|---|---|
| Study | Stability |
| Room Temperature (15-30°C) | 2 days |
| Refrigerated (2-8°C) | 7 days |
| Freeze/Thaw Cycles | 5 cycles |
CUT-OFF VERIFICATION:
A verification study was performed to ensure that the original cut-off values were appropriate for the modified LIAISON® HAV IgM.
The user may continue to use the following cut-off values for interpretation of patient results.
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| Index | Results | Interpretation |
|---|---|---|