(26 days)
Not Found
No
The summary describes a standard chemiluminescence immunoassay (CLIA) for detecting antibodies. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is used for the qualitative detection of specific IgG antibodies to varicella-zoster virus in human serum to aid in the determination of previous infection, not for treating any condition.
Yes
The device is described as an "aid in the determination of previous infection of varicella-zoster virus" by detecting specific IgG antibodies, which is a diagnostic purpose.
No
The device description clearly states it is a chemiluminescence immunoassay (CLIA) and includes controls based in human serum, indicating it is a laboratory-based test kit with physical reagents and components, 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 device is for the "qualitative detection of specific IgG antibodies to varicella-zoster virus (VZV) in human serum." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to gain information about a physiological state (previous VZV infection).
- Device Description: The "Device Description" further clarifies that it's an "indirect chemiluminescence immunoassay (CLIA) for qualitative determination of specific IgG antibodies to varicella-zoster virus in human serum." This confirms the in vitro nature of the test.
- Controls: The description of the controls also indicates they are "based in human serum," reinforcing the use of human biological samples.
These characteristics align directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DiaSorin LIAISON® VZV IgG uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer family for the qualitative detection of specific IgG antibodies to varicella-zoster virus (VZV) in human serum. This assay can be used as an aid in the determination of previous infection of varicella-zoster virus. The assay performance in detecting antibodies to VZV in individuals vaccinated with the FDA-licensed VZV vaccine is unknown. The user of this assay is responsible for establishing the performance characteristics with VZV vaccinated individuals.
The DiaSorin LIAISON® Control VZV IgG (negative) is intended for use as assayed quality control samples to monitor the performance of the DiaSorin LIAISON® VZV IgG assay on the LIAISON® Analyzer family. The performance characteristics of the LIAISON® Control VZV IgG have not been established for any other assays or instrument platforms different from LIAISON® and LIAISON® XL.
Product codes (comma separated list FDA assigned to the subject device)
LFY, JJX
Device Description
The LIAISON® VZV IgG is an indirect chemiluminescence immunoassay (CLIA) for qualitative determination of specific IgG antibodies to varicella-zoster virus in human serum.
The LIAISON® Control VZV IgG are liquid ready-to-use controls based in human serum. The negative control is intended to provide an assay response characteristic of negative patient specimens and the positive control is intended to provide an assay response characteristic of positive patient specimens.
The assay and controls are designed for use with DiaSorin LIAISON® Analyzer family.
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)
Non-clinical verification and validation testing conducted with the LIAISON® VZV IgG and LIAISON® Control VZV IgG demonstrate that the modified devices met predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device. Evidence is demonstrated through the following studies:
Real Time Stability testing conducted on the LIAISON® VZV IgG to support the following product claims:
- Eight (8) weeks On-Board/Open Use Stability
- Eight (8) weeks Stability of Calibration
Real time stability testing on human serum specimens to support storage claims:
- Seven (7) Days Refrigerated (2-8°C)
- Five (5) Freeze-Thaw Cycles
Testing of the LIAISON® Control VZV IgG to validate and verify:
- Commutability between Samples and Controls (Matrix Effect)
- Precision Equivalence between Samples and Controls
- 20 Day Precision
- 5 Day Precision
- Control Value Assignment
- Control Range Definition
Real Time Stability testing conducted on the LIAISON® Control VZV IgG to support the following product claims:
- Shelf-life of 18 months at (2-8°C)
- Eight (8) weeks On-Board/Open Use Stability
Based on the findings from the validation and verification activities, the modifications to the LIAISON® VZV IgG and LIAISON® Control VZV IgG do not introduce any new risks to the performance of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
LIAISON® VZV IgG (K061820)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 866.3900 Varicella-zoster virus serological reagents.
(a)
Identification. Varicella-zoster virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to varicella-zoster in serum. The identification aids in the diagnosis of diseases caused by varicella-zoster viruses and provides epidemiological information on these diseases. Varicella (chicken pox) is a mild, highly infectious disease, chiefly of children. Zoster (shingles) is the recurrent form of the disease, occurring in adults who were previously infected with varicella-zoster viruses. Zoster is the response (characterized by a rash) of the partially immune host to a reactivation of varicella viruses present in latent form in the patient's body.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract image of a human face.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 11, 2015
DIASORIN INCORPORATED JOHN C. WALTER PRESIDENT 1951 NORTHWESTERN AVE. STILLWATER, MN 55082
Re: K150375
Trade/Device Name: LIAISON® VZV IgG and LIAISON® Control VZV IgG Regulation Number: 21 CFR 866.3900 Regulation Name: Varicella-zoster virus serological reagents Regulatory Class: Class II Product Code: LFY, JJX Dated: February 12, 2015 Received: February 13, 2015
Dear Mr. Walter:
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21CFR 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,
Stephen J. Lovell -S for
Sally Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150375
Device Name LIAISON® VZV IgG LIAISON® Control VZV IgG
Indications for Use (Describe)
The DiaSorin LIAISON® VZV IgG uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer family for the qualitative detection of specific IgG antibodies to varicella-zoster virus (VZV) in human serum. This assay can be used as an aid in the determination of previous infection of varicella-zoster virus. The assay performance in detecting antibodies to VZV in individuals vaccinated with the FDA-licensed VZV vaccine is unknown. The user of this assay is responsible for establishing the performance characteristics with VZV vaccinated individuals.
The DiaSorin LIAISON® Control VZV IgG (negative) is intended for use as assayed quality control samples to monitor the performance of the DiaSorin LIAISON® VZV IgG assay on the LIAISON® Analyzer family. The performance characteristics of the LIAISON® Control VZV IgG have not been established for any other assays or instrument platforms different from LIAISON® and LIAISON® XL.
Type of Use (Select one or both, as applicable):
| ☑ Prescription Use (Part 21 CER 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
SUBMITTED BY:
Sandra Zimniewicz Requlatory Affairs Specialist DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater, MN 55082-0285 Email: sandra.zimniewicz@diasorin.com
DATE PREPARED:
February 12, 2015
NAME OF DEVICE:
Trade Name:
LIAISON® VZV IgG LIAISON® Control VZV IgG
Common Names/Description: VZV IgG Assay and VZV IgG Controls
Classification:
Varicella-zoster virus Serological Reagents: 21 CFR 866.3900; Class III (performance standards); Microbiology (83)
Product Code:
LFY, JJX
LIAISON® VZV IgG (K061820) PREDICATE DEVICE:
DEVICE DESCRIPTION:
The LIAISON® VZV IgG is an indirect chemiluminescence immunoassay (CLIA) for qualitative determination of specific IgG antibodies to varicella-zoster virus in human serum.
The LIAISON® Control VZV IqG are liquid ready-to-use controls based in human serum. The negative control is intended to provide an assay response characteristic of negative patient specimens and the positive control is intended to provide an assay response characteristic of positive patient specimens.
The assay and controls are designed for use with DiaSorin LIAISON® Analyzer familv.
INTENDED USE:
The DiaSorin LIAISON® VZV IgG uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer family for the qualitative detection of specific IgG
4
antibodies to varicella-zoster (VZV) in human serum. This assay can be used as an aid in the determination of previous infection of varicella-zoster virus.
The assay performance in detecting antibodies to VZV in individuals vaccinated with the FDA-licensed VZV vaccine is unknown. The user of this assay is responsible for establishing the performance characteristics with VZV vaccinated individuals.
The DiaSorin LIAISON® Control VZV IgG (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the DiaSorin LIAISON® VZV IgG assay on the LIAISON® Analyzer family. The performance characteristics of the LIAISON® Control VZV IgG have not been established for any other assay or instrument platforms different from LIAISON® and LIAISON® XL.
COMPARISON TO THE PREDICATE (Description of the Modifications to the Legally Marketed Device):
Modifications to the DiaSorin LIAISON® VZV IgG assay include an increase in the number of tests provided per kit, extension of on board/open use and calibration stability, the addition of serum specimen stability claim for 5 freeze-thaw cycles and the extension of refrigerated storage (2-8ºC) for serum specimens from two (2) days to seven (7) days.
Changes to the DiaSorin LIAISON® Control VZV IgG include a 100% serum/defibrinated plasma based matrix and the extension of the open use stability claim.
The following tables provide a summary of the similarities and differences between the FDA cleared LIAISON® VZV IgG, LIAISON® Control VZV IgG and the modified devices.
| Table of Similarities LIAISON® VZV IgG | |||
|---|---|---|---|
| Characteristic | Predicate Device DiaSorin | ||
| LIAISON® VZV IgG K061820, | |||
| cleared 02/26/2007 | Modified Device | ||
| DiaSorin LIAISON® VZV IgG | |||
| Intended | |||
| Use/Indications for | |||
| Use | The DiaSorin LIAISON® VZV IgG uses | ||
| chemiluminescence immunoassay (CLIA) | |||
| technology on the LIAISON® Analyzer family for the | |||
| qualitative detection of specific IgG antibodies to | |||
| varicella-zoster virus (VZV) in human serum. This | |||
| assay can be used as an aid in the determination | |||
| of previous infection of varicella-zoster virus. | |||
| The assay performance in detecting antibodies to | |||
| VZV in individuals vaccinated with the FDA | |||
| licensed VZV vaccine is unknown. The user of this | |||
| assay is responsible for establishing the | |||
| performance characteristics with VZV vaccinated | |||
| individuals. | Same | ||
| Technology/ | |||
| Assay Principle | Chemiluminescent Immunoassay (CLIA) | Same | |
| Sample | |||
| Handling/Assay | |||
| Processing | Automated | Same | |
| Reagent Integral | |||
| Configuration | |||
| (1 compartment | |||
| each reagent) | • Magnetic particles | ||
| • Calibrator 1 | |||
| • Calibrator 2 | |||
| • Specimen Diluent | |||
| • Conjugate | Same | ||
| Raw materials | No Change | ||
| • Antigen: Inactivated varicella-zoster virus | |||
| lysate (ROD strain) | |||
| • Detector: Mouse monoclonal anti-human | |||
| IgG conjugated to isoluminol derivative | |||
| • Capture: Magnetic microparticles coated | |||
| with varicella-zoster antigen | Same | ||
| Reagent | |||
| Formulation | No Change | Same | |
| Manufacturing | |||
| Process | No Change | Same | |
| Storage | Store at 2-8°C until ready to use | Same | |
| Measured Analyte | IgG antibodies to Varicella-zoster virus | Same | |
| Sample Type | Human Serum | Same | |
| Sample Volume | 20 uL | Same | |
| Assay Procedure | • Dispense calibrators, controls, or samples | ||
| • Dispense magnetic particles | |||
| • Dispense specimen diluent | |||
| • Incubate | |||
| • Wash | |||
| • Dispense conjugate | |||
| • Incubate | |||
| • Wash | |||
| • Dispense starter reagent | |||
| • Measure Light emitted (RLUs) | Same | ||
| Total Incubation | |||
| Time | 21 minutes | Same | |
| Measurement | |||
| System | Photomultiplier (flash chemiluminescence reader) | Same | |
| Calibration | Two point verification of stored master curve | Same | |
| Unit of Measure | Index Value | Same | |
| Cut-Off | 150 Index Value | Same | |
| Equivocal Zone | 135 - 165 Index Value | Same | |
| Calibrators | Included with kit | Same | |
| Assay Performance | |||
| Characteristics | No Change | Same | |
| Controls | Provided Separately | Same | |
| Table of Differences LIAISON® VZV IgG | |||
| Characteristic | Predicate Device DiaSorin | ||
| LIAISON® VZV IgG K061820, | |||
| cleared 02/26/2007 | Modified Device | ||
| DiaSorin LIAISON® VZV IgG | |||
| Tests per Kit | 50 | 100 | |
| Reagent Volume | |||
| Provided | Magnetic particles (1.3ml) | ||
| Conjugate (13ml) | Magnetic particles (2.5 ml) | ||
| Conjugate (23ml) | |||
| Open Use/On | |||
| Board Stability | Four (4) weeks at 2-8°C or on board the | ||
| analyzer | Eight (8) weeks at 2-8°C or onboard | ||
| the analyzer | |||
| Calibration Stability | Fourteen (14) days | Eight (8) weeks | |
| Serum Storage at | |||
| 2-8°C | Two (2) days | Seven (7) days | |
| Serum Storage | |||
| Freeze-Thaw | |||
| Cycles | Samples should not be repeatedly frozen | ||
| and thawed. | Twelve samples with different reactivity | ||
| underwent five (5) freeze-thaw cycles. | |||
| The results showed no significant | |||
| differences. |
5
6
| Summary of Similarities and Differences LIAISON® Control VZV IgG | ||
|---|---|---|
| Characteristic | Predicate Device | |
| DiaSorin LIAISON® Control VZV IgG | ||
| K061820, cleared 02/26/2007 | Modified Device | |
| DiaSorin LIAISON® Control VZV IgG | ||
| Intended Use | The LIAISON® VZV IgG controls | |
| (negative, positive controls) are used for | ||
| monitoring substantial reagent failure of | ||
| the LIAISON® VZV IgG chemiluminescent | ||
| immunoassay (CLIA). The LIAISON® VZV | ||
| IgG quality control material contains a 5% | ||
| serum matrix and may not adequately | ||
| control the DiaSorin LIAISON® VZV IgG | ||
| assay for serum specimens. The | ||
| performance of the LIAISON® VZV IgG | ||
| controls has not been established with | ||
| any other VZV assay or instrument | ||
| platforms different from LIAISON® and | ||
| LIAISON® XL. | The DiaSorin LIAISON® Control VZV | |
| IgG (negative and positive) is intended | ||
| for use as assayed quality control | ||
| samples to monitor the performance of | ||
| the DiaSorin LIAISON® VZV IgG assay | ||
| on the LIAISON® Analyzer family. The | ||
| performance characteristics of the | ||
| LIAISON® VZV Control IgG have not | ||
| been established for any other assay | ||
| or instrument platforms different from | ||
| LIAISON® and LIAISON® XL. | ||
| Negative Control | 5% Human Serum/plasma non-reactive | |
| for VZV IgG antibodies, stabilized in | ||
| TRIS-NaCl buffer, preservatives. | Human Serum/plasma non-reactive for | |
| VZV IgG antibodies, 0.2% ProClin. | ||
| Positive Control | 5% Human Serum/plasma reactive for | |
| VZV IgG antibodies, stabilized in TRIS- | ||
| NaCl buffer, preservatives, inert yellow | ||
| dye. | Human Serum/plasma reactive for | |
| VZV IgG antibodies, 0.2% ProClin. | ||
| Reagent | ||
| Configuration | 2 vials each level (negative and positive) | |
| 0.7 mL/vial, ready to use. | Same | |
| Storage | Store at 2-8°C until ready to use | Same |
| Open Use Stability | Once opened controls are stable for four | |
| (4) weeks when properly stored at 2-8°C | ||
| between uses. | Once opened controls are stable for | |
| eight (8) weeks when properly stored | ||
| at 2-8°C between uses. |
7
SUMMARY OF PERFORMANCE DATA:
Non-clinical verification and validation testing conducted with the LIAISON® VZV IgG and LIAISON® Control VZV IgG demonstrate that the modified devices met predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device. Evidence is demonstrated through the following studies:
Real Time Stability testing conducted on the LIAISON® VZV IgG to support the following product claims:
- . Eight (8) weeks On-Board/Open Use Stability
- Eight (8) weeks Stability of Calibration ●
Real time stability testing on human serum specimens to support storage claims:
- Seven (7) Days Refrigerated (2-8°C)
- Five (5) Freeze-Thaw Cycles .
Testing of the LIAISON® Control VZV IgG to validate and verify:
- Commutability between Samples and Controls (Matrix Effect) .
- Precison Equivalence between Samples and Controls
- o 20 Day Precison
- o 5 Day Precision
- Control Value Assignment ●
- Control Range Definition ●
Real Time Stability testing conducted on the LIAISON® Control VZV IgG to support the following product claims:
- Shelf-life of 18 months at (2-8°C) .
- Eight (8) weeks On-Board/Open Use Stability .
Based on the findings from the validation and verification activities, the modifications to the LIAISON® VZV IgG and LIAISON® Control VZV IgG do not introduce any new risks to the performance of the device.
CONCLUSION:
As summarized, the DiaSorin LIAISON® VZV IgG and LIAISON® Control VZV IgG, are substantially equivalent to the originally cleared devices. The changes to the device do not constitute new intended/indications for use, or changes to the fundamental scientific technology. Performance testing of the device demonstrates that the device functions as intended, meeting the requirements of design specifications. The device was determined to be substantially equivalent to the previously cleared device.
The material submitted in this Special 510(k) is complete and supports a substantial equivalence decision. The labeling satisfies the requirements of 21 CFR 809.10.