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510(k) Data Aggregation
(86 days)
LIAISON XL ANALYZER
The LIAISON® Anti-HAV assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of total antibodies to hepatitis A (anti-HAV) in human serum and sodium heparin plasma samples using the LIAISON® Analyzer family. The assay is indicated as an aid in the laboratory diagnosis of current or previous HAV infections in conjunction with other serological and clinical information and to determine the presence of an antibody response to HAV in vaccine recipients.
This assay is not intended for screening blood or solid or soft tissue donors. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. The user is responsible for establishing assay performance characteristics in these populations. Caution: U.S. Federal Law restricts this device to sale by or on the order of a physician.
The LIAISON® XL Analyzer is an automated discrete continuous loading chemiluminescent immunoassay (CLIA) analyzer for in vitro diagnostic analysis of CLIAs on human specimens cleared for use on the analyzer. It is only to be used with FDA cleared chemiluminescent immunoassays that are marketed by DiaSorin for the LIAISON® XL Analyzer. The analyzer can be connected to a third party Laboratory Automation System (LAS) which has been previously cleared for use with FDA cleared assays.
The LIAISON® Control Anti-HAV (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Anti-HAV assay.
The performance characteristics of LIAISON® controls have not been established for any other assays or instrument platforms different from LIAISON® XL and LIAISON® XL with LIAISON® XL Workcell Upgrade Kit.
The LIAISON® XL Analyzer is an in vitro diagnostic device consisting of loading areas (for samples, Reagent Integrals, ancillary reagents, Starter Reagents, Cuvettes, Disposable Tips, water, Wash Buffer, maintenance liquid); incubator, wash station, reader, and a barcode reader for reagents and samples. Installation of the LIAISON® XL Workcell Upgrade Kit allows the LIAISON® XL Analyzer to be used with a compatible LAS and extends the sample pipetting capabilities to a point-in-space located external to the analyzer.
This submission (K141116) describes the LIAISON® XL Workcell Upgrade Kit, which allows the LIAISON® XL Analyzer (predicate device K103529) to connect to a Laboratory Automation System (LAS) and extends its sample pipetting capabilities. The device itself (the Workcell Upgrade Kit) is essentially a modification to the LIAISON® XL Analyzer, enabling new functionality rather than being a diagnostic assay with specific performance metrics like sensitivity or specificity for a disease.
Therefore, the acceptance criteria and study proving its efficacy are focused on demonstrating that the modified LIAISON® XL Analyzer (with the Workcell Upgrade Kit) performs equivalently to the predicate LIAISON® XL Analyzer for its intended use (running the LIAISON® Anti-HAV assay).
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a typical table of acceptance criteria and performance for a diagnostic assay (e.g., sensitivity, specificity, accuracy). Instead, the acceptance criteria for this device modification are implicitly about maintaining the performance and functional equivalence of the predicate device when the upgrade kit is installed and used, especially when connected to a Laboratory Automation System.
The "device performance" reported is that the new device (LIAISON® XL with Workcell Upgrade Kit) is "substantially equivalent" to the predicate device (LIAISON® XL Analyzer) for its existing intended use with the LIAISON® Anti-HAV assay.
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Maintain the intended use of the LIAISON® Anti-HAV assay. | The intended use of the LIAISON® Anti-HAV assay remains identical for both the predicate and the new device. It is intended for the qualitative detection of total antibodies to hepatitis A (anti-HAV) in human serum and sodium heparin plasma samples using the LIAISON® Analyzer family, as an aid in diagnosing current or previous HAV infections and determining antibody response in vaccine recipients. |
| Maintain the fundamental principles of operation. | The principles of operation (Chemiluminescence using magnetic particle solid phase and chemiluminescent tracer, optical system, temperature control, dispense system, reagent handling, starter reagents, reaction modules, test processing, assay protocols, data analysis, QC software, specimens, disposables) are all stated as "Same" between the predicate and the new device. |
| Ensure proper sample aspiration, identification, and LAS communication. | The new device allows for sample aspiration directly from the sample bay (standalone mode) and from a point-in-space presented by the Workcell to the aspiration point (LAS mode). Sample identification via barcodes is maintained in both standalone and LAS modes (using the Workcell's barcode scanner). The key change and performance element relate to the enabling and proper functioning of the LAS interface communication protocol. |
| No adverse impact on existing assay performance characteristics. | The submission states that "The results from the non-clinical studies submitted in this premarket notification demonstrate that the LIAISON® XL Workcell Upgrade Kit is substantially equivalent to the predicate device." This implies that existing performance characteristics of the LIAISON® Anti-HAV assay on the LIAISON® XL platform are maintained when the Workcell Upgrade Kit is present and/or utilized. Specific data to support this would be in the non-clinical studies referenced, but not provided in this summary. |
| Proper functioning of the LAS interface. | The software now has the "LAS interface enabled," and the LIAISON® XL software communicates with the Workcell via a "LAS interface communication protocol." The study would have demonstrated this communication and integrated functionality. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for a "test set" in the traditional sense of a diagnostic assay evaluation (e.g., number of patient samples for sensitivity/specificity). This submission is for a device modification (an upgrade kit for an existing analyzer) rather than a novel diagnostic assay.
The evaluation would likely involve:
- Functional testing: Verifying that the Workcell Upgrade Kit integrates correctly with the LIAISON® XL Analyzer and a Laboratory Automation System.
- Performance verification: Ensuring that the LIAISON® Anti-HAV assay, when run on the LIAISON® XL Analyzer with the Workcell Upgrade Kit (especially through LAS integration), yields results consistent with those obtained on the predicate device without the upgrade. This would involve running a series of samples (controls, patient samples) to confirm precision, accuracy, and overall analytical performance are maintained.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for a device modification, the studies would typically be prospective functional and performance verification studies conducted in a controlled laboratory environment.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This is not a study assessing diagnostic accuracy against a clinical ground truth established by experts. It is a technical submission for a device modification.
4. Adjudication Method:
Not applicable for a device modification study focused on functional and performance equivalence.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not a study evaluating human reader performance, with or without AI assistance.
6. Standalone Performance:
Yes, a standalone performance was done in the sense that the studies demonstrated that the LIAISON® XL Analyzer with the Workcell Upgrade Kit still functions as a standalone analyzer (where samples are placed directly into the sample bay, as in the predicate device). The capabilities are maintained ("Same (in the stand alone mode)"). Additionally, the primary purpose of the upgrade is to enable the "LAS mode" functionality. The non-clinical studies would have verified the performance of the analyzer both in standalone mode and with the LAS integration.
7. Type of Ground Truth Used:
The "ground truth" for this type of submission would be the established and cleared performance characteristics (e.g., precision, linearity, analytical sensitivity, cut-off values) of the LIAISON® Anti-HAV assay when run on the predicate LIAISON® XL Analyzer. The studies would have demonstrated that the modified analyzer's performance for this assay does not deviate significantly from these established values.
8. Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI device that requires a distinct training set for algorithm development. The "training" in this context would refer to the development and internal testing of the hardware and software modifications of the Workcell Upgrade Kit to ensure it performs as intended.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there's no machine learning "training set" in the context of this device modification. The "ground truth" for verifying the functional and performance aspects of the Workcell Upgrade Kit would be derived from:
- Engineering specifications and design requirements for the Workcell itself and its integration with LAS.
- The established performance specifications of the LIAISON® Anti-HAV assay on the predicate LIAISON® XL Analyzer.
- Industry standards and regulatory guidelines for laboratory automation and immunoassay systems.
In summary, this 510(k) is about demonstrating substantial equivalence for a modification to an existing device rather than establishing novel diagnostic performance for an assay. The studies focus on ensuring that the new functionalities (LAS connectivity, extended pipetting) correctly integrate without negatively impacting the already cleared performance of the LIAISON® XL Analyzer when running the LIAISON® Anti-HAV assay.
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(51 days)
LIAISON XL ANALYZER MODEL 10050
The LIAISON® Anti-HAV assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of total antibodies to hepatitis A (anti-HAV) in human serum and sodium heparin plasma samples using the LIAISON® Analyzer family. The assay is indicated as an aid in the laboratory diagnosis of current or previous HAV infections in conjunction with other serological and clinical information and to determine the presence of an antibody response to HAV in vaccine recipients.
This assay is not intended for screening blood or solid or soft tissue donors. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. The user is responsible for establishing assay performance characteristics in these populations. Caution: U.S. Federal Law restricts this device to sale by or on the order of a physician.
The LIAISON® XL Analyzer is an automated discrete continuous loading chemiluminescent immunoassay (CLIA) analyzer for in vitro diagnostic analysis of CLIAs on human serum or plasma. The system menu includes infectious disease, bone and mineral, and endocrinology CLIAs. It is to be used only with FDA cleared chemiluminescence immunoassays that are marketed by DiaSorin for the LIAISON XL Analyzer.
The LIAISON® Control Anti-HAV (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Anti-HAV assay.
The performance characteristics of LIAISON® controls have not been established for any other assays or instrument platforms different from LIAISON® and LIAISON® XL.
The LIAISON® XL Analyzer is an automated discrete continuous loading chemiluminescent immunoassay (CLIA) analyzer for in vitro diagnostic analysis of CLIAs on human serum or plasma. The system menu includes infectious disease, bone and mineral, and endocrinology CLIAs. It is to be used only with FDA cleared chemiluminescence immunoassays that are marketed by DiaSorin for the LIAISON XL Analyzer.
The LIAISON® Control Anti-HAV (negative and positive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® Anti-HAV assay.
The performance characteristics of LIAISON® controls have not been established for any other assays or instrument platforms different from LIAISON® and LIAISON® XL.
The method for qualitative determination of anti-HAV is a competitive sandwich chemiluminescence immunoassay (CLIA) based on neutralization. Antibodies to HAV (mouse monoclonal) are used for coating magnetic particles (solid phase) and are linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, anti-HAV present in calibrators, samples or controls binds to a fixed and limited amount of HAV, thus forming an HAV-anti-HAV immune complex. During the second incubation, the antibody conjugate and the solid-phase antibody compete with anti-HAV present in the specimen for HAV, that allows the conjugate to bind to the solid phase and thus form a "sandwich" of conjugate antibody-antigen-solid phase antibody. If all HAV added is sequestered in an HAVanti-HAV immune complex during the first incubation, no sandwich is formed during the second incubation. After the second incubation, the unbound material is removed with a wash cycle.
Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminolantibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is inversely indicative of anti-HAV present in calibrators, samples or controls.
The LIAISON® XL Analyzer is an automated discrete continuous loading chemiluminescent immunoassay analyzer for in vitro diagnostic use.
The provided text describes a 510(k) premarket notification for the DiaSorin LIAISON® XL Analyzer, referencing the LIAISON® Anti-HAV assay. However, the document does not contain specific acceptance criteria, comprehensive study results demonstrating performance against numerical criteria, or detailed information about sample sizes, ground truth establishment, or expert qualifications for a performance study.
The submission focuses primarily on demonstrating substantial equivalence of the LIAISON® XL Analyzer to its predicate device, the LIAISON® Analyzer, by comparing their features. While it mentions the intended use of the LIAISON® Anti-HAV assay, it does not provide the clinical study data requested.
Therefore, I cannot populate the table with acceptance criteria and reported performance, nor can I provide the requested details about the study design, sample sizes, experts, or ground truth, as this information is not present in the provided text.
The closest information available is the comparison table between the LIAISON® Analyzer and the LIAISON® XL Analyzer, outlining similarities and differences in their features and operational aspects, rather than performance metrics against specific acceptance criteria for a diagnostic test.
Summary of what can be gleaned from the text (and what is explicitly missing):
- Acceptance Criteria & Reported Device Performance: Not provided in the text. The document focuses on demonstrating substantial equivalence to a predicate device through feature comparison, not quantitative performance metrics against pre-defined acceptance criteria for the assay.
- Sample Size (Test Set) & Data Provenance: Not provided.
- Number of Experts & Qualifications: Not provided.
- Adjudication Method: Not provided.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not indicated or described. The device is a laboratory analyzer, not a device requiring human reader interpretation in the context of an MRMC study.
- Standalone Performance Study: A standalone performance study for the LIAISON® Anti-HAV assay on the LIAISON® XL Analyzer would typically include data on sensitivity, specificity, accuracy, precision, etc. This information is not present in the provided text, which is a 510(k) summary focused on the analyzer itself and its substantial equivalence to a previous version.
- Type of Ground Truth: Not provided.
- Sample Size (Training Set): Not applicable, as this is an immunoassay analyzer and assay, not an AI algorithm that requires a training set in that context.
- How Ground Truth for Training Set was Established: Not applicable.
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