(70 days)
For the qualitative and semi-quantitative detection of human antibodies to SSA nuclear 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. For In Vitro Diagnostic Use Only.
For in vitro diagnostic use only. For the qualitative and semi-quantitative detection of IgG antibodies to SSA 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-SSA 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 SSA nuclear antigen (Anti-SSA) , in human serum. The Calibrators in the SeraQuest Anti-SSA 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 SeraQuest® Anti-SSA device based on the provided text, focusing on acceptance criteria and the supporting study:
The provided document describes a 510(k) premarket notification for the SeraQuest® Anti-SSA device, which is an in vitro diagnostic (IVD) test. For IVDs, "acceptance criteria" usually refers to agreement or concordance rates with a legally marketed predicate device or a clinical diagnosis. The "study" here is a comparative study against a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or agreement. Instead, it presents the results of a comparison study with a predicate device, implying that the observed agreement rates were deemed acceptable for substantial equivalence.
Implied Acceptance Criteria and Reported Performance for SeraQuest® Anti-SSA vs. Shield Diastat Anti-SSA:
| Metric | Implied Acceptance Criteria (Based on Substantial Equivalence to Predicate) | Reported Device Performance (95% CI) |
|---|---|---|
| Relative Sensitivity | High agreement with predicate for positive cases. | 96.1% (91.8% to 100%) |
| Relative Specificity | High agreement with predicate for negative cases. | 96.1% (93.5% to 98.8%) |
| Overall Agreement | High overall agreement with predicate. | 93.9% (93.9% to 98.4%) |
Note: The acceptance criteria are "implied" because the document states the device is "substantially equivalent in intended use and performance" to the predicate, and these performance metrics are presented in the "Summary of Clinical Testing" to support that claim.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 288 serum specimens.
- Data Provenance: The document does not explicitly state the country of origin. It also does not specify if the data was retrospective or prospective. Given the nature of a 510(k) submission for an IVD, it is common for such comparative studies to use banked or archival specimens (retrospective), but this is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The "ground truth" in this context is established by the predicate device, the Shield Diastat Anti-SSA test. The document does not mention:
- Any human experts used to establish the ground truth for the test set.
- The qualifications of any such experts.
- This is an IVD device, and the "ground truth" for evaluating its performance is its concordance with a legally marketed predicate device rather than direct expert consensus on clinical presentation or pathology.
4. Adjudication Method for the Test Set
There was no direct expert adjudication method described for the test set. The comparison was solely against the results of the predicate device (Shield Diastat Anti-SSA). Discrepancies between the two tests were noted and quantified (e.g., 8 positive by SeraQuest but negative by Shield), but there's no mention of a third-party or expert review to "adjudicate" these differences.
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 device is an in vitro diagnostic (EIA) test, which is read instrumentally or visually based on a color change and threshold. It does not involve human "readers" interpreting imaging or complex patterns where an MRMC study would be applicable. The effectiveness is measured by its analytical performance (sensitivity, specificity, agreement) against a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the study described is a standalone performance study of the device. As an in vitro diagnostic test, the SeraQuest Anti-SSA kit performs its function (detecting antibodies) independently of human cognitive interpretation or "in-the-loop" assistance for a diagnosis. The results are quantitative (Index values) and qualitative (Positive/Equivocal/Negative) based on the assay's biochemical reactions and photometric readings. While a human initiates the test and interprets the final numerical/categorical output, the core performance relates to the test's ability to correctly identify the presence or absence of antibodies. The comparison described is between the standalone SeraQuest device and the standalone predicate device.
7. The Type of Ground Truth Used
The primary ground truth used for the validation study was the results obtained from a legally marketed predicate device: the Shield Diastat Anti-SSA test.
The intent is to show that the new device performs comparably to an already accepted device.
8. The Sample Size for the Training Set
The document does not provide any information regarding a "training set" or its sample size. For 510(k) submissions of IVD kits, especially for enzyme immunoassays like this one, the focus is typically on the validation study demonstrating performance against a predicate or an established clinical diagnosis, rather than describing a machine learning "training set." The development process for an EIA usually involves optimization and validation steps, but these are not referred to as "training" in the sense of machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, no information is available on how its ground truth was established.
§ 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).