(74 days)
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.
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).
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.
The LIAISON® CMV IgG Serum Control Set (negative and positive) consists of liquid ready-touse controls in human serum/defibrinated plasma. 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 controls are designed for use with DiaSorin LIAISON® CMV IgG assay on the LIAISON® Analyzer family.
Here's a summary of the acceptance criteria and study information for the LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria or specific numerical reported device performance values for the LIAISON® CMV IgG assay (which remains unchanged from the predicate device). However, it focuses on the performance of the LIAISON® CMV IgG Serum Control Set. The acceptance criteria for the controls are described qualitatively:
| Acceptance Criteria Category | Specific Criteria (from text) | Reported Device Performance (from text) |
|---|---|---|
| LIAISON® CMV IgG Serum Control Set | ||
| Commutability | Commutability between samples and controls (matrix effect) | Meets predetermined acceptance criteria, supporting equivalency. |
| Precision Equivalence | Precision equivalence between samples and controls | Meets predetermined acceptance criteria, supporting equivalency. |
| 20-Day Precision | (Implicit: acceptable precision over 20 days) | Meets predetermined acceptance criteria, supporting equivalency. |
| Control Value Assignment | (Implicit: accurate assignment of control values) | Meets predetermined acceptance criteria, supporting equivalency. |
| Control Range Definition | (Implicit: appropriate definition of control ranges) | Meets predetermined acceptance criteria, supporting equivalency. |
| Shelf-Life Stability | Shelf-life of 12 months at (2-8°C) | Real-time stability testing supports this claim. |
| Open Use Stability | Eight (8) weeks open use stability when stored at 2-8°C between uses | Real-time stability testing supports this claim. |
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not specify the exact sample sizes used for the "Test Set" in the context of commutability, precision, control value assignment, or control range definition. It mentions "samples and controls" for precision equivalence. For stability testing, it states "Real time stability testing," implying a duration-based study rather than a fixed sample count of individual specimens.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be internal to the manufacturer (DiaSorin Inc.). The document implies these are non-clinical verification and validation studies. It does not clarify if the data is retrospective or prospective, but real-time stability testing would be prospective.
3. Number of Experts and Qualifications for Ground Truth
This information is not provided in the document. The device is an immunoassay for detecting antibodies, which typically relies on laboratory-defined cut-offs and established reference methods for "ground truth", rather than expert interpretation of images or clinical cases.
4. Adjudication Method for the Test Set
This information is not provided as it's not relevant for an immunoassay that doesn't involve subjective interpretation or a panel of experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done, as this type of study is relevant for imaging devices or algorithms that involve human interpretation and reader variability. The LIAISON® CMV IgG is an automated immunoassay.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The LIAISON® CMV IgG assay is a standalone algorithm/device for its performance. It measures IgG antibodies to hCMV in human serum automatically. The controls are also designed to monitor this automated performance. The study described focuses on the performance characteristics of the controls and their impact on the assay itself, rather than comparing its performance with or without human intervention for result interpretation.
7. Type of Ground Truth Used
The ground truth for immunoassay performance is typically established by:
- Reference methods/panels (e.g., CDC reference panels).
- Clinically characterized samples (e.g., samples from known CMV-positive and CMV-negative individuals).
- Comparison to a legally marketed predicate device (as in this 510(k), where the assay's performance is stated as "No Change" from the cleared predicate, K040290).
The document states that the studies demonstrate the modified device (Control Set) meets "predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device." This strongly implies the ground truth for establishing acceptance and equivalency relies on the established performance characteristics and values of the predicate device and/or defined laboratory standards.
8. Sample Size for the Training Set
The document does not specify a training set sample size, as this filing is for a modification to an already cleared device (the control set for an existing assay). The primary focus is on validating the new control set, not on developing or training a new algorithm from scratch.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned for a new algorithm development, this information is not applicable in the context of this 510(k) submission for a control set modification. For the original assay (K040290), ground truth would have been established using methods mentioned in point 7.
§ 866.3175 Cytomegalovirus serological reagents.
(a)
Identification. Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.(b)
Classification. Class II (performance standards).