LIAISON VZV IgG, LIAISON Control VZV IgG

K150375 · DiaSorin, Inc. · LFY · Mar 11, 2015 · Microbiology

Device Facts

• Record ID: K150375
• Device Name: LIAISON VZV IgG, LIAISON Control VZV IgG
• Applicant: DiaSorin, Inc.
• Product Code: LFY · Microbiology
• Decision Date: Mar 11, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3900
• Device Class: Class 2

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 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.

Device Story

LIAISON® VZV IgG is an indirect chemiluminescence immunoassay (CLIA) for qualitative detection of IgG antibodies to VZV in human serum. Device uses automated processing on LIAISON® Analyzer family; inputs include patient serum samples; assay involves incubation with magnetic microparticles coated with inactivated VZV lysate (ROD strain) and mouse monoclonal anti-human IgG conjugate. Analyzer measures light emission (RLUs) via photomultiplier. Output is index value indicating presence of IgG antibodies. Used in clinical laboratories by trained personnel. Results aid clinicians in determining patient's history of VZV infection. Controls (LIAISON® Control VZV IgG) are used to monitor assay performance. Modifications include increased kit size, extended on-board/open-use stability, extended calibration stability, and updated serum storage claims.

Clinical Evidence

Bench testing only. Validation included stability studies for reagents, calibrators, controls, and serum samples. Precision and matrix effect studies were performed to verify the impact of modifications. No clinical trial data presented.

Technological Characteristics

Chemiluminescent immunoassay (CLIA) using magnetic microparticles coated with inactivated VZV lysate (ROD strain) and mouse monoclonal anti-human IgG conjugate. Automated processing on LIAISON® Analyzer family. Measured via photomultiplier. Reagents stored at 2-8°C. Controls consist of 100% human serum matrix with 0.2% ProClin.

Indications for Use

Indicated for qualitative detection of specific IgG antibodies to varicella-zoster virus (VZV) in human serum to aid in determining previous VZV infection. Performance in vaccinated individuals is unknown.

Regulatory Classification

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.

Predicate Devices

• LIAISON® VZV IgG (K061820)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER K150375

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.

LIAISON® VZV IgG and LIAISON® Control VZV IgG

510(k) number: K061820

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED. There are changes in labeling which are described below.

3. A description of the device MODIFICATION(S), in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

The changes were for:

A. Changes to the LIAISON VZV IgG:

1. Increase in number of tests per kit from 50 to 100 tests.
2. Extension of On-Board and Open Use stability claim for the Reagent Integral from four weeks to eight weeks when stored at 2-8°C in a refrigerator or on board the analyzer.
3. Calibration stability extension from two weeks to eight weeks.
4. Extend refrigerated storage (2-8°C) for specimens from two days to seven days.
5. Addition of specimen stability claim that allows samples to undergo five freeze-thaw cycles.
6. Changes to the Quality Control recommendations to reflect the change in the matrix composition of the LIAISON® Control VZV IgG.

B. Changes to the LIAISON® Control VZV IgG:

1. Controls (Positive and Negative) to be provided in a serum based matrix (100% human serum).
2. Extension of On-Board and Open Use stability claim for controls from four weeks to eight weeks when stored at 2-8°C.
3. Addition of a description of Assigned Values of the controls and the procedure for using the controls.

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## 4. Comparison Information

| 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 |

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| Similarities LIAISON® VZV IgG | | |
| --- | --- | --- |
| Characteristic | Predicate Device
DiaSorin LIAISON® VZV IgG K061820,
cleared 02/26/2007 | Modified Device
DiaSorin LIAISON® VZV IgG |
| 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 |

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| 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 | 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 | Two (2) days | Seven (7) days |
| Serum Storage Freeze-Thaw Cycles | Samples should not be repeatedly frozen and thawed. | Samples are stable through five (5) freeze-thaw cycles. |
| Similarities LIAISON® Control VZV IgG | | |
| --- | --- | --- |
| Characteristic | Predicate Device
DiaSorin LIAISON® VZV IgG K061820, cleared 02/26/2007 | Modified Device
DiaSorin LIAISON® 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. |
| 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 |

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| Differences LIAISON® Control VZV IgG | | |
| --- | --- | --- |
| Characteristic | Predicate Device
DiaSorin LIAISON® VZV IgG
K061820, cleared 02/26/2007 | Modified Device
DiaSorin LIAISON® VZV IgG |
| Negative Control | 5% Human Serum non-reactive for VZV IgG antibodies, stabilized in TRIS-NaCl buffer, preservatives. | Human Serum 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 reactive for VZV IgG antibodies, 0.2% ProClin. |
| 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. |

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied. Stability studies on reagents, calibrators, controls and serum were carried out. Precision and matrix effect studies were also performed.

c) A “Declaration of Conformity” statement was also submitted for the manufacturing facility and validation activities and signed by the Quality Assurance and Regulatory Affairs Manager, Italy. The statements indicate that:

I. The manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

II. The validation activities, as required by the risk analysis, for the modification were performed by the designated individuals and the results demonstrated that the predetermined acceptance criteria were met.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.