LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set

K162961 · DiaSorin, Inc. · LSE · Jan 5, 2017 · Microbiology

Device Facts

• Record ID: K162961
• Device Name: LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set
• Applicant: DiaSorin, Inc.
• Product Code: LSE · Microbiology
• Decision Date: Jan 5, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3235
• Device Class: Class 1

Indications for Use

The LIAISON® VCA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) viral capsid antigen (VCA) p18 synthetic peptide in human serum. When performed in conjunction with other EBV markers, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr Viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis. The DiaSorin LIAISON® VCA IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® VCA IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® VCA IgG controls have not been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL. The LIAISON® EBNA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) nuclear antigen synthetic peptide (EBNA-1) in human serum. When performed in conjunction with other EBV markers, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr Viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis. The DiaSorin LIAISON® EBNA IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® EBNA IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® EBNA IgG controls have not been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL.

Device Story

The DiaSorin LIAISON® VCA IgG and EBNA IgG assays are chemiluminescent immunoassays (CLIA) for qualitative detection of IgG antibodies to EBV viral capsid antigen and nuclear antigen in human serum. The device modification involves the LIAISON® VCA IgG and EBNA IgG Serum Control Sets. The control matrix was changed from a 5% human serum/defibrinated plasma buffer-based solution to a 100% human serum/defibrinated plasma matrix. The open-use stability claim for these controls was extended from 4 to 8 weeks at 2–8°C. The assays are performed on the LIAISON® Analyzer family (LIAISON® and LIAISON® XL) in clinical laboratory settings. The controls are used by laboratory personnel to monitor assay performance and reagent integrity. The output is a qualitative determination of specific IgG antibodies, which assists clinicians in diagnosing Epstein-Barr Viral Syndrome.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including stability studies, precision studies, and matrix effect studies to validate the performance of the modified control sets.

Technological Characteristics

Chemiluminescent immunoassay (CLIA); automated processing; 100% human serum/defibrinated plasma control matrix; preservatives: 0.1% ProClin® 300 and 0.09% sodium azide; storage 2-8°C; compatible with LIAISON® and LIAISON® XL analyzers.

Indications for Use

Indicated for qualitative detection of IgG antibodies to EBV VCA p18 or EBNA-1 in human serum. Used as an aid in clinical laboratory diagnosis of Epstein-Barr Viral Syndrome in patients with signs/symptoms of EBV infection (e.g., infectious mononucleosis).

Regulatory Classification

Identification

Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).

Predicate Devices

• DiaSorin LIAISON® VCA IgG (K040120)
• DiaSorin LIAISON® EBNA IgG (K040120)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER K162961

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

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

DiaSorin LIAISON® VCA IgG

DiaSorin LIAISON® EBNA IgG

510(k) number: K040120

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, and package labeling.

The intended uses of the DiaSorin LIAISON® VCA IgG assay and the DiaSorin LIAISON® EBNA IgG assay did not change. The intended uses of the Controls (required for the assays and sold separately) were updated to reflect the change in the Control matrix.

3. A description of the device MODIFICATIONS in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

A. Changes to the DiaSorin LIAISON® VCA IgG assay and the DiaSorin LIAISON® EBNA IgG assay:

1. The Quality Control section of the package inserts was updated to reflect the change in the Control matrix.

B. Changes to the LIAISON® Control VCA IgG and the LIAISON® Control EBNA IgG:

1. The names are changed to LIAISON® VCA IgG Serum Control Set and LIAISON® EBNA IgG Serum Control Set.

2. The Positive and Negative Controls included in the LIAISON® VCA IgG Serum Control Set and the LIAISON® EBNA IgG Serum Control Set are provided in a matrix of 100% human serum/defibrinated plasma instead of in a matrix comprised of buffer and 5% human serum/defibrinated plasma.

3. The Open Use stability claim of the LIAISON® VCA IgG Serum Control Set and the LIAISON® EBNA IgG Serum Control Set is extended from 4 weeks to 8 weeks when stored at 2 – 8°C. The storage conditions of the Controls did not change.

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4. Comparison Information

| LIAISON® VCA IgG assay | | |
| --- | --- | --- |
| | Predicate Device
DiaSorin LIAISON® VCA IgG, K040120, Cleared
04/29/2005 | Modified Device
LIAISON® VCA IgG and
LIAISON® VCA IgG
Serum Control Set |
| Intended Use/Indications for Use | The LIAISON® VCA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) viral capsid antigen (VCA) p18 synthetic peptide in human serum. When performed in conjunction with other EBV markers, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr Viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis.
*(LIAISON® and LIAISON® XL) | No Change |
| Technology/Assay Principle | Chemiluminescent Immunoassay (CLIA) | No Change |
| Sample Handling / Assay Processing | Automated | No Change |
| Storage | Store at 2-8°C until ready to use | No Change |
| Measured Analyte | IgG antibodies to Epstein-Barr virus (EBV) viral capsid antigen | No Change |
| Assay Performance Characteristics | No Change | No Change |
| Labeling (Instructions for Use) | References buffer based controls | References serum based controls |
| Controls | Provided Separately | No Change |

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| LIAISON® VCA IgG Serum Control Set | | |
| --- | --- | --- |
| | Predicate Device
DiaSorin LIAISON® VCA IgG, K040120, Cleared 04/29/2005 | Modified Device
LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set |
| Intended Use | The LIAISON® VCA IgG Controls (negative, positive) are used for monitoring substantial reagent failure of the LIAISON® VCA IgG chemiluminescent immunoassay (CLIA). The LIAISON® VCA IgG quality control material contains a 5% serum matrix and may not adequately control the DiaSorin LIAISON® VCA IgG assay for serum specimens. The performance of the LIAISON® VCA IgG Controls has not been established with any other EBV assay or instrument platforms different from LIAISON® and LIAISON® XL. | The DiaSorin LIAISON® VCA IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® VCA IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® VCA IgG controls have not been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL.

*(LIAISON® and LIAISON® XL) |
| Negative Control | 5% human serum/defibrinated plasma non-reactive for VCA IgG antibodies, diluted in PBS buffer, BSA, with ProClin® 300 as a preservative. | Human serum/defibrinated plasma non-reactive for VCA IgG antibodies, 0.1% ProClin® 300 and 0.09% sodium azide. |
| Positive Control | 5% Human serum/defibrinated plasma reactive for VCA IgG antibodies, diluted in PBS buffer, BSA, with ProClin® 300 as a preservative and an inert yellow dye. | Human serum/defibrinated plasma reactive for VCA IgG antibodies, 0.1% ProClin® 300 and 0.09% sodium azide. |
| Reagent Configuration | 2 vials each level (negative and positive) 0.9 mL/vial, ready to use. | No change |
| Storage | Store at 2 – 8°C | No change |
| 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. |

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| LIAISON® EBNA IgG assay | | |
| --- | --- | --- |
| | Predicate Device
DiaSorin LIAISON® EBNA
IgG, K040120, Cleared
04/29/2005 | Modified Device
LIAISON® EBNA IgG
and LIAISON® EBNA
IgG Serum Control Set |
| Intended Use/Indications for Use | The LIAISON® EBNA IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of specific IgG antibodies to Epstein-Barr virus (EBV) nuclear antigen synthetic peptide (EBNA-1) in human serum. When performed in conjunction with other EBV markers, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr Viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis.

*(LIAISON® and LIAISON® XL) | No Change |
| Technology/Assay Principle | Chemiluminescent Immunoassay (CLIA) | No Change |
| Sample Handling / Assay Processing | Automated | No Change |
| Storage | Store at 2-8° C until ready to use | No Change |
| Measured Analyte | IgG antibodies to Epstein-Barr virus (EBV) nuclear antigen | No Change |
| Assay Performance Characteristics | No Change | No Change |
| Labeling (Instructions for Use) | References buffer based controls | References serum based controls |
| Controls | Provided Separately | No Change |

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| LIAISON® EBNA IgG Serum Control Set | | |
| --- | --- | --- |
| | Predicate Device
DiaSorin LIAISON® EBNA IgG, K040120, Cleared 04/29/2005 | Modified Device
LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control Set |
| Intended Use | The LIAISON® EBNA IgG Controls (negative, positive) are used for monitoring substantial reagent failure of the LIAISON® EBNA IgG chemiluminescent immunoassay (CLIA). The LIAISON® EBNA IgG quality control material contains a 5% serum matrix and may not adequately control the DiaSorin LIAISON® EBNA IgG assay for serum specimens. The performance of the LIAISON® EBNA IgG Controls has not been established with any other EBV assay or instrument platforms different from LIAISON® and LIAISON® XL. | The DiaSorin LIAISON® EBNA IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® EBNA IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® EBNA IgG controls have not been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL.
*(LIAISON® and LIAISON® XL) |
| Negative Control | 5% human serum/defibrinated plasma non-reactive for EBNA IgG antibodies, diluted in PBS buffer, BSA, with ProClin® 300 as a preservative. | Human serum/defibrinated plasma non-reactive for EBNA IgG antibodies, 0.1% ProClin® 300 and 0.09% sodium azide. |
| Positive Control | 5% Human serum/defibrinated plasma reactive for EBNA IgG antibodies, diluted in PBS buffer, BSA, with ProClin® 300 as a preservative and an inert yellow dye. | Human serum/defibrinated plasma reactive for EBNA IgG antibodies, 0.1% ProClin® 300 and 0.09% sodium azide. |
| Reagent Configuration | 2 vials each level (negative and positive) 0.9 mL/vial, ready to use. | No change |
| Storage | Store at 2 – 8°C | No change |
| 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 used to assess the impact of the modification on the device and its components, and the results of the analysis.

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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 the modified Controls were performed. 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 Senior Director Regulatory Affairs and Quality Assurance. 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 these modified subject devices has been reviewed to verify that the indications/intended uses for the devices, the LIAISON® VCA IgG assay and the LIAISON® EBNA IgG assay, are unaffected by the modification. The intended uses of the components, the LIAISON® VCA IgG Serum Control Set and the LIAISON® EBNA IgG Serum Control Set, were updated to reflect the change in composition of the Control matrix. In addition, the submitter's description of the particular modifications 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 devices be determined substantially equivalent to the previously cleared devices.

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