(116 days)
- For in vitro diagnostic use only.
- For the qualitative and semi-quantitative detection of IgG antibodies to SSB antigen in human serum by enzyme immunoassay.
- For use as an aid in the diagnosis of systemic rheumatic disease, particularly Sjogren's Syndrome.
- For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.
The SeraQuest Anti-SSB test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against SSB nuclear antigen (Anti-SSB), in human serum. The Calibrators in the SeraQuest Anti-SSB test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to demonstrate the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicitly Derived from Predicate Performance) | Reported Device Performance (SeraQuest Anti-SSB) |
|---|---|
| Relative sensitivity comparable to predicate device (Shield Diastat Anti-SSB) | 96.4% (95% CI: 89.6% to 100%) |
| Relative specificity comparable to predicate device (Shield Diastat Anti-SSB) | 97.2% (95% CI: 95.3% to 99.3%) |
| Overall agreement comparable to predicate device (Shield Diastat Anti-SSB) | 99.6% (95% CI: 95.3% to 99.1%) |
Note: The document doesn't explicitly state quantitative acceptance criteria. Instead, it presents a comparison to a predicate device (Shield Diastat Anti-SSB) and implies that performance "comparable" to the predicate, as demonstrated by the study results, is acceptable for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): 288 specimens
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "human serum" specimens. The study design appears to be retrospective, as existing specimens were tested with both the new device and the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study uses the Shield Diastat Anti-SSB test as the comparator or "reference" for evaluating the SeraQuest Anti-SSB test, rather than an independent expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided. Given that the predicate device's results were used as the comparator, it's unlikely a separate adjudication process was involved beyond comparing the two test results.
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 done. This study compares the performance of two diagnostic tests (SeraQuest Anti-SSB vs. Shield Diastat Anti-SSB), not the performance of human readers 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 study was done. The SeraQuest Anti-SSB test is a lab-based enzyme immunoassay, which is an "algorithm only" device in the context of its operation and interpretation. The results were compared directly against another lab-based assay (the predicate).
7. The Type of Ground Truth Used
The "ground truth" for this study was the results from the predicate device, the Shield Diastat Anti-SSB test. The study evaluates the substantial equivalence of the new device's performance against an existing, legally marketed device.
8. The Sample Size for the Training Set
This information is not applicable/provided. The SeraQuest Anti-SSB test is a biochemical assay (Enzyme Immunoassay) and does not involve AI or machine learning algorithms that would require a "training set" in the conventional sense. Any internal optimization or development of the assay would have used internal validation data, but this is not a training set as understood in AI/ML contexts.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the reasons stated in point 8.
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).