LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set

K162959 · DiaSorin, Inc. · LSE · Jan 4, 2017 · Microbiology

Device Facts

• Record ID: K162959
• Device Name: LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set
• Applicant: DiaSorin, Inc.
• Product Code: LSE · Microbiology
• Decision Date: Jan 4, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3235
• Device Class: Class 1

Indications for Use

The LIAISON® EA 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) early antigen-diffuse [EA(D)] in human serum. This assay uses a 47-kDa recombinant antigen expressed in E. coli DH-1 cells. 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 infectious mononucleosis. The DiaSorin LIAISON® EA IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® EA IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® EA IgG controls have not been established for any other assay or instrument platforms different from the LIAISON® and LIAISON® XL.

Device Story

The LIAISON® EA IgG assay is an automated chemiluminescent immunoassay (CLIA) used on LIAISON® and LIAISON® XL analyzers to detect IgG antibodies to EBV early antigen-diffuse [EA(D)] in human serum. The system utilizes a 47-kDa recombinant antigen expressed in E. coli. The device modification involves the LIAISON® EA IgG Serum Control Set, which now uses a 100% human serum/defibrinated plasma matrix instead of a 5% serum/buffer matrix. The open-use stability for these controls is extended to 8 weeks at 2–8°C. The assay is performed in clinical laboratories to assist in diagnosing Epstein-Barr Viral Syndrome. Results are interpreted by clinicians alongside other EBV markers to support clinical decision-making.

Clinical Evidence

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

Technological Characteristics

Chemiluminescent immunoassay (CLIA); automated processing on LIAISON®/LIAISON® XL analyzers. Controls consist of human serum/defibrinated plasma with 0.1% ProClin® 300 and 0.09% sodium azide. Storage at 2–8°C; open-use stability 8 weeks. Recombinant 47-kDa antigen expressed in E. coli DH-1 cells.

Indications for Use

Indicated for qualitative determination of IgG antibodies to Epstein-Barr virus (EBV) early antigen-diffuse [EA(D)] in human serum to aid in the clinical laboratory diagnosis of Epstein-Barr Viral Syndrome in patients with signs and symptoms of EBV infection, such as 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® EA IgG (K060204)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Summary

To: THE FILE

RE: DOCUMENT NUMBER K162959

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® EA IgG

510(k) number: K060204

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 use of the DiaSorin LIAISON® EA IgG assay did not change. The intended use of the Controls (required for the assay and sold separately) was 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 LIAISON® EA IgG assay

1. The Quality Control section of the package insert is updated to reflect the change in the Control matrix.

B. Changes to the LIAISON® Control EA IgG:

1. The name is changed to LIAISON® EA IgG Serum Control Set.
2. The Positive and Negative Controls included in the LIAISON® EA IgG Serum Control Set (Controls) 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® EA 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® EA IgG assay | | |
| --- | --- | --- |
| | Predicate Device DiaSorin LIAISON® EA IgG, K060204, Cleared 10/18/2006 | Modified Device LIAISON® EA IgG and LIAISON® EA IgG Serum Control Set |
| Intended Use/Indications for Use | The LIAISON® EA 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) early antigen-diffuse [EA(D)] in human serum. This assay uses a 47-kDa recombinant antigen expressed in E. coli DH-1 cells. 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) early antigen-diffuse [EA(D)] | 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® EA IgG Serum Control Set | | |
| --- | --- | --- |
| | Predicate Device
DiaSorin LIAISON® EA IgG,
K060204, Cleared 10/18/2006 | Modified Device
LIAISON® EA IgG and
LIAISON® EA IgG Serum
Control Set |
| Intended Use | The LIAISON® EA IgG Controls (negative, positive) are used for monitoring substantial reagent failure of the LIAISON® EA IgG chemiluminescent immunoassay (CLIA). The LIAISON® EA IgG quality control material contains only a 5% serum matrix and may not adequately control the DiaSorin LIAISON® EA IgG assay for serum specimens. The performance of the LIAISON® EA IgG Controls has not been established with any other EA assay or instrument platforms different from LIAISON® and LIAISON® XL. | The DiaSorin LIAISON® EA IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® EA IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® EA 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 EA IgG antibodies, diluted in PBS buffer, BSA, with ProClin® 300 as a preservative. | Human serum/defibrinated plasma non-reactive for EA IgG antibodies, 0.1% ProClin® 300 and 0.09% sodium azide. |
| Positive Control | 5% Human serum/defibrinated plasma reactive for EA IgG antibodies, diluted in PBS buffer, BSA, with ProClin® 300 as a preservative and an inert yellow dye. | Human serum/defibrinated plasma reactive for EA IgG antibodies, 0.1% ProClin® 300 and 0.09% sodium azide. |
| Reagent Configuration | 2 vials each level (negative and positive) 0.7 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 this modified subject device has been reviewed to verify that the indication/intended use for the device, the LIAISON® EA IgG assay, is unaffected by the modification. The intended use of the component LIAISON® EA IgG Serum Control Set was 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 device be determined substantially equivalent to the previously cleared device.

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