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510(k) Data Aggregation
(481 days)
DIASORIN LIAISON CMV IGM/IGG
The LIAISON® CMV IgG assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer 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 LIAISON® CMV IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgM antibodies to human cytomegalovirus (hCMV) in human serum. It is intended to be used as an aid in the diagnosis of acute CMV infection.
The method for qualititative determination of specific IgG to hCMV is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the LIAISON® Chemiluminescence Analyzer. The principal components of the test are magnetic particles (solid phase) coated with hCMV antigen and a conjugate of mouse monoclonal antibody to human IqG linked to an isoluminol derivative (isoluminol-antibody conjugate).
The method for qualititative determination of specific IgM to hCMV is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the LIAISON® Chemiluminescence Analyzer. The principal components of the test are magnetic particles (solid phase) coated with hCMV antigen, a buffer of goat IgG to human IgG and a conjugate of mouse monoclonal antibody to human IgM linked to an isoluminol derivative (isoluminolantibody conjugate).
Here's a breakdown of the acceptance criteria and study information for both the LIAISON® CMV IgG and LIAISON® CMV IgM assays, based on the provided text:
LIAISON® CMV IgG Assay
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to a predicate device (DiaSorin CMV IgG ELISA Kit K955361) and a general expectation of high agreement. Specific numerical targets for acceptance criteria are not explicitly stated as "acceptance criteria" but rather as "percent agreement" for different sample types.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Prospective Samples | High overall agreement with predicate assay. | Overall Agreement: 98.13% (314/320) |
| High positive agreement with predicate assay. | Positive Agreement: 100.0% (178/178) | |
| High negative agreement with predicate assay. | Negative Agreement: 96.45% (136/141) | |
| Pregnancy Samples | High overall agreement with predicate assay. | Overall Agreement: 99.01% (200/202) |
| High positive agreement with predicate assay. | Positive Agreement: 99.43% (175/176) | |
| High negative agreement with predicate assay. | Negative Agreement: 96.15% (25/26) | |
| Retrospective Samples | High overall agreement with known positive samples. | Overall Agreement: 100.0% (100/100) |
| High positive agreement with known positive samples. | Positive Agreement: 100.0% (100/100) | |
| Reproducibility | Acceptable within-run, between-run, and between-site precision. | Overall %CV values ranged from 7.68% to 22.07%. |
| Interference | No significant interference from common interfering substances. | No effects from hemolysis, lipemia, icterus (within tested limits). |
| Cross-Reactivity | No significant cross-reactivity with related infectious agents. | 0/46 samples showed positive results (with caveats). |
2. Sample Size and Data Provenance for Test Set
-
Sample Sizes:
- Prospective Samples: 320 samples
- Pregnancy Samples: 202 samples
- Retrospective Samples (Suspected Acute CMV Infection): 100 samples
- Reproducibility Panel: 9 frozen repository serum samples (tested 90 times each, 3 replicates per run for 10 runs across 4 sites).
- Interference Studies: Not explicitly stated for specific sample count, but "controlled studies" were performed.
- Cross-Reactivity Panel: 46 samples (from various conditions/organisms).
-
Data Provenance:
- Country of Origin: The clinical trials were conducted at two external US laboratories and at DiaSorin.
- Retrospective or Prospective: Both retrospective (repository) and prospective samples were used.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The ground truth was established by comparison to a "comparison assay" (DiaSorin CMV IgG ELISA Kit). It's implied that the reference method itself effectively serves as the "expert" for establishing the ground truth.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable/not specified. The study compared the new device's results directly against a predicate device (DiaSorin CMV IgG ELISA Kit). There's no indication of an expert adjudication process beyond the results of the predicate assay.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This is an in-vitro diagnostic device (immunoassay), not an imaging or interpretation device that would typically involve human "readers." The performance is measured directly by the assay's output.
6. Standalone Performance (Algorithm Only)
- Standalone Performance Done: Yes. The performance metrics presented (percent agreement, reproducibility, interference, cross-reactivity) are all "standalone" in the sense that they describe the device's performance without human interpretation or intervention in the final result determination, other than following the manufacturer's instructions for use. The device directly produces qualitative (Negative, Equivocal, Positive) or quantitative (U/mL) results.
7. Type of Ground Truth Used
- Ground Truth Type: Comparison to a predicate device (DiaSorin CMV IgG ELISA Kit). For the retrospective samples, it refers to "Suspected Acute CMV Infection," implying clinical diagnosis or established serological status.
8. Sample Size for Training Set
- Training Set Sample Size: Not specified. The document describes clinical performance data using test sets, but typically for immunoassay development, specific training set sizes are not disclosed in the same manner as for AI/ML algorithms. The development involved antigen selection and optimization, which indirectly uses data to establish assay parameters.
9. How Ground Truth for Training Set Was Established
- Ground Truth Establishment for Training Set: Not specified in the provided text. For an immunoassay, the "training" aspect would involve optimizing reagent concentrations, incubation times, and cutoff values using a panel of known positive and negative samples, which would have their ground truth established through clinical diagnosis, confirmed infection, or other reference methods (like another established ELISA).
LIAISON® CMV IgM Assay
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to a predicate device (Diamedix Is-CMV IgM Capture ELISA Kit K001767) and a general expectation of high agreement. Specific numerical targets for acceptance criteria are not explicitly stated as "acceptance criteria" but rather as "percent agreement" for different sample types.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Prospective Samples | High overall agreement with predicate assay. | Overall Agreement: 90.79% (1361/1499) |
| High positive agreement with predicate assay. | Positive Agreement: 90.70% (39/43) | |
| High negative agreement with predicate assay. | Negative Agreement: 93.23% (1322/1418) | |
| Pregnancy Samples | High overall agreement with predicate assay. | Overall Agreement: 98.50% (197/200) |
| High negative agreement with predicate assay. | Negative Agreement: 98.50% (197/200) | |
| Positive agreement not applicable due to 0 positives. | Positive Agreement: N/A | |
| Retrospective Samples | High overall agreement with known positive samples. | Overall Agreement: 97.0% (97/100) |
| High positive agreement with known positive samples. | Positive Agreement: 100.0% (97/97) | |
| Reproducibility | Acceptable within-run, between-run, and between-site precision. | Overall %CV values ranged from 10.97% to 26.59%. |
| Interference | No significant interference from common interfering substances. | No effects from hemolysis, lipemia, icterus (within tested limits). |
| Cross-Reactivity | No significant cross-reactivity with related infectious agents. | 2/67 samples showed positive results (with caveats). |
2. Sample Size and Data Provenance for Test Set
-
Sample Sizes:
- Prospective Samples: 1499 samples (U.S. 610; European 889)
- Pregnancy Samples: 200 samples
- Retrospective Samples (Suspected Acute CMV Infection): 100 samples
- Reproducibility Panel: 9 frozen repository serum samples (tested 90 times each, 3 replicates per run for 10 runs across 4 sites).
- Interference Studies: Not explicitly stated for specific sample count, but "controlled studies" were performed.
- Cross-Reactivity Panel: 67 samples (from various conditions/organisms).
-
Data Provenance:
- Country of Origin: Clinical trials were conducted at two external US laboratories and at DiaSorin. Prospective samples included both U.S. and European origin.
- Retrospective or Prospective: Both retrospective (repository) and prospective samples were used.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The ground truth was established by comparison to a "comparison assay" (Diamedix Is-CMV IgM Capture ELISA Kit). It's implied that the reference method itself effectively serves as the "expert" for establishing the ground truth.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable/not specified. The study compared the new device's results directly against a predicate device (Diamedix Is-CMV IgM Capture ELISA Kit). There's no indication of an expert adjudication process beyond the results of the predicate assay.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This is an in-vitro diagnostic device (immunoassay), not an imaging or interpretation device that would typically involve human "readers." The performance is measured directly by the assay's output.
6. Standalone Performance (Algorithm Only)
- Standalone Performance Done: Yes. The performance metrics presented (percent agreement, reproducibility, interference, cross-reactivity) are all "standalone" in the sense that they describe the device's performance without human interpretation or intervention in the final result determination, other than following the manufacturer's instructions for use. The device directly produces qualitative (Negative, Equivocal, Positive) or quantitative (AU/mL) results.
7. Type of Ground Truth Used
- Ground Truth Type: Comparison to a predicate device (Diamedix Is-CMV IgM Capture ELISA Kit). For the retrospective samples, it refers to "Suspected Acute CMV Infection," implying clinical diagnosis or established serological status.
8. Sample Size for Training Set
- Training Set Sample Size: Not specified. The document describes clinical performance data using test sets, but typically for immunoassay development, specific training set sizes are not disclosed in the same manner as for AI/ML algorithms. The development involved antigen selection and optimization, which indirectly uses data to establish assay parameters.
9. How Ground Truth for Training Set Was Established
- Ground Truth Establishment for Training Set: Not specified in the provided text. For an immunoassay, the "training" aspect would involve optimizing reagent concentrations, incubation times, and cutoff values using a panel of known positive and negative samples, which would have their ground truth established through clinical diagnosis, confirmed infection, or other reference methods (like another established ELISA).
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