LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set

{0} SPECIAL 510(k): Device Modification OIR Decision Summary To: THE FILE RE: DOCUMENT NUMBER K162969 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® CMV IgG 510(k) number: K040290 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® CMV 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 DiaSorin LIAISON® CMV IgG assay: 1. The Quality Control section of the package insert was updated to reflect the change in the Control matrix. B. Changes to the LIAISON® Control CMV IgG: 1. The name is changed to LIAISON® CMV IgG Serum Control Set. 2. The Positive and Negative Controls included in the LIAISON® CMV 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® CMV IgG Serum Control Set is extended from 4 weeks to 8 weeks when stored at 2 – 8°C. The storage condition of the Controls did not change. {1} # 4. Comparison Information | LIAISON® CMV IgG assay | | | | --- | --- | --- | | | Predicate Device DiaSorin LIAISON® CMV IgG, K040290, Cleared 06/01/2005 | Modified Device LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set | | Intended Use/Indications for Use | The LIAISON® CMV IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer family* for the qualitative determination of IgG antibodies to human cytomegalovirus (hCMV) in human serum. It is intended to be used as an aid in the determination of serological status to CMV. *(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 human cytomegalovirus (hCMV) | 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 | {2} | LIAISON® CMV IgG Serum Control Set | | | | --- | --- | --- | | | Predicate Device DiaSorin LIAISON® CMV IgG, K040290, Cleared 06/01/2005 | Modified Device LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set | | Intended Use | The LIAISON® CMV IgG Controls (negative, positive) are used for monitoring substantial reagent failure of the LIAISON® CMV IgG chemiluminescent immunoassay (CLIA). The LIAISON® CMV IgG quality control material contains only a 5% serum matrix and may not adequately control the DiaSorin LIAISON® CMV IgG assay for serum specimens. The performance of the LIAISON® CMV IgG Controls has not been established with any other CMV assay or instrument platforms different from LIAISON® and LIAISON® XL. | The DiaSorin LIAISON® CMV IgG Serum Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® CMV IgG assay on the LIAISON® Analyzer family*. The performance characteristics of the LIAISON® CMV 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 CMV IgG antibodies, diluted in PBS buffer, BSA, with ProClin® 300 as a preservative. | Human serum/defibrinated plasma non-reactive for CMV IgG antibodies, 0.1% ProClin® 300 and 0.09% sodium azide. | | Positive Control | 5% Human serum/defibrinated plasma reactive for CMV IgG antibodies, diluted in PBS buffer, BSA, with ProClin® 300 as a preservative and an inert yellow dye. | Human serum/defibrinated plasma reactive for CMV 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. | {3} 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. 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 indication/intended use for the device, the LIAISON® CMV IgG assay, is unaffected by the modification. The intended use of the component, the LIAISON® CMV 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. 4