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510(k) Data Aggregation
(242 days)
The AxSYM Rubella IgM Antibody assay is a Microparticle Enzyme Immunoassay (MEIA) for the qualitative measurement of IgM antibodies to rubella virus in human serum and plasma (EDTA, heparin or sodium citrate) to aid in the diagnosis of primary or acute infection. The AxSYM Rubella IgM assay is not for use with cord blood or neonatal specimens.
The AxSYM Rubella IgM Antibody assay is an automated microparticle enzyme immunoassay performed with the AxSYM, a random and continuously accessed automated immunoassay analyzer. It is an in vitro immunologic test method intended for use in the detection of IgM antibody to rubella virus in human serum or plasma (EDTA, heparin or sodium citrate). It is based on the formation of immune complexes between rubella virus antigens and antibody, uses a polystyrene microparticle solid phase coated with antigen from rubella virus strain HPV-77 grown in Vero cell culture, and uses goat anti-human IgM antibody conjugated to alkaline phosphatase with MUP as the enzyme substrate. The AxSYM Rubella IgM Antibody assay pretreats all samples with an RF neutralization buffer.
The provided 510(k) summary describes the Abbott Laboratories AxSYM Rubella IgM Antibody Assay.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" but rather describes the performance of the new device (AxSYM) in comparison to a predicate device (IMx). The implicit acceptance criteria appear to be substantial equivalence, meaning the performance metrics of the AxSYM assay should be comparable to or better than the predicate IMx assay.
| Metric | AxSYM Rubella IgM (Reported Performance) | IMx Rubella IgM (Predicate Device Performance) |
|---|---|---|
| Relative Sensitivity | 95.7% | 95.4% |
| Relative Specificity | 99.4% | 99.4% |
| Relative Agreement | 99.1% | Not explicitly stated for IMx, but the comparison implies this is the target. |
| Percent CV's on positive panel members and positive controls | 6.9% to 12.6% | Not explicitly stated for IMx, but satisfactory according to regulatory standards. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 1300 samples
- Data Provenance: The study was conducted retrospectively using samples from three clinical sites. The document does not specify the country of origin, but given it's an Abbott Laboratories submission, it's likely primarily US-based, though not explicitly stated. The samples were from pregnant women, non-pregnant individuals, and individuals positive for IgM antibodies to rubella.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of a diagnostic interpretation. Instead, the predicate device, Abbott's IMx Rubella IgM Antibody assay, served as the primary reference for comparison.
For the 11 discordant specimens, two additional legally marketed assays (Abbott Rubazyme M EIA and BioWhittaker RUBASTAT M) were used for further evaluation. However, the document does not specify human experts or their qualifications involved in interpreting these additional assay results to resolve discrepancies.
4. Adjudication Method for the Test Set:
For the initial comparison, the IMx Rubella IgM Antibody assay served as the reference. For discordant specimens (n=11), a method involving two additional legally marketed assays (Abbott Rubazyme M EIA and BioWhittaker RUBASTAT M) was used. The results from these additional assays were used to classify the discordant samples.
- If two assays agreed (e.g., AxSYM positive, IMx negative, and one of the other assays positive), that result likely informed the adjudication.
- Samples that remained equivocal after the additional testing were excluded from the calculation of relative agreement, sensitivity, and specificity. This indicates a form of adjudication where inconclusive results were set aside.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described. This study focuses on the performance of an automated assay (AxSYM) compared to another automated assay (IMx) using existing samples, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone performance evaluation was done. The study directly compares the performance of the AxSYM Rubella IgM Antibody assay (an automated algorithm/device) against the IMx Rubella IgM Antibody assay (another automated device). There is no mention of human interpretation or involvement in the diagnostic output generation of either assay.
7. The Type of Ground Truth Used:
The ground truth for the study was established using the results of a predicate device (Abbott's IMx Rubella IgM Antibody assay). For discordant cases, further adjudication was performed using two other legally marketed assays. While these are "legally marketed assays," they serve as a form of "reference standard" or "consensus of commercial assays," rather than a gold standard such as pathology or long-term clinical outcomes. No mention of pathology or clinical outcomes data is made.
8. The Sample Size for the Training Set:
The document does not provide information about a training set or its sample size. The description pertains to the performance evaluation of an already developed device, not the development phase where a training set would typically be used. The 510(k) summary focuses on demonstrating substantial equivalence of the finished product.
9. How the Ground Truth for the Training Set Was Established:
As no training set is mentioned, information on how its ground truth was established is not provided.
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