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1. For in vitro diagnostic use only.
2. For the qualitative and semi-quantitative detection of IgG antibodies to Sm in human serum by enzyme immunoassay.
3. For use as an aid in the diagnosis of systemic lupus erythematosus (SLE).
4. For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

The SeraQuest Anti-Sm 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 Sm nuclear antigen (Anti-Sm) , in human serum. The Calibrators in the SeraQuest Anti-Sm test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.

This document describes the 510(k) summary for the SeraQuest® Anti-Sm immunological test system.

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is demonstrated through a comparative study against a predicate device. While explicit "acceptance criteria" are not listed as predefined thresholds for sensitivity, specificity, and agreement, the study results are presented to support substantial equivalence.

2. Sample Size and Data Provenance

• Test Set Sample Size: 236 serum specimens.
• Data Provenance: The study was performed at Quest International, Inc., Miami, FL. The document does not explicitly state the country of origin of the serum specimens, but given the company location, it is likely the data is from the USA. It is a retrospective study as existing serum specimens were tested.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish a ground truth for the test set. Instead, the performance is evaluated by comparison to a predicate device, the Shield Diastat Anti-Sm test. The "ground truth" for the performance metrics is based on the results obtained from the predicate device.

The table does include a row indicating "Number of patients with clinically diagnosed SLE." for positive cases, which suggests some clinical diagnosis context, but this is not explicitly stated as the primary ground truth for the comparative study's performance metrics. For the 236 specimens, 10 were positive for clinically diagnosed SLE.

4. Adjudication Method for the Test Set

No adjudication method is described. The comparison is direct between the SeraQuest Anti-Sm test and the Shield Diastat Anti-Sm test.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. This device is an in vitro diagnostic (IVD) assay, not an imaging or diagnostic device that requires human interpretation.

6. Standalone Performance Study

Yes, a standalone performance study was done in the sense that the SeraQuest Anti-Sm test was run independently on 236 serum specimens, and its results were then compared to those obtained from the predicate device. The performance metrics (relative sensitivity, specificity, and agreement) are a direct result of this independent testing and subsequent comparison.

7. Type of Ground Truth Used

The primary "ground truth" or reference for the performance metrics (sensitivity, specificity, and agreement) in this study is the predicate device's results (Shield Diastat Anti-Sm test). The comparative study aims to show that the new device performs substantially equivalently to the predicate.

Additionally, for the positive cases, it's mentioned that 10 were "patients with clinically diagnosed SLE," indicating that clinical diagnosis (a form of outcomes data or expert clinical assessment) serves as an underlying reference for the predicate device's intended use and, by extension, the new device's claim for aiding in SLE diagnosis. However, the performance metrics of sensitivity, specificity, and agreement are calculated against the predicate device's results.

8. Sample Size for the Training Set

The document does not provide any information about a "training set" or sample size used for training. This likely indicates that the device's development did not involve a machine learning model, but rather a traditional laboratory assay development process.

9. How the Ground Truth for the Training Set was Established

Since no training set is mentioned for the device itself (as it's an immunoassay, not an AI/ML device), this information is not applicable.

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• 1 . For in vitro diagnostic use only.
• 2. For the qualitative and semi-quantitative detection of IgG antibodies to Sm/RNP in human serum by enzyme immunoassay.
• For use as an aid in the diagnosis of systemic rheumatic disease, particularly 3. mixed connective tissue disease (MCTD).
• For manual use, or for use with the HyPrep System Plus semi-automated fluid 4. handler.

The SeraQuest® Anti-Sm/RNP 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 Sm/RNP nuclear antigen (Anti-Sm/RNP), in human serum.

The Calibrators in the SeraQuest Anti-Sm/RNP 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 regarding the SeraQuest® Anti-Sm/RNP device's acceptance criteria and studies:

Key Takeaways Before Diving In:

• This is a 510(k) summary, which means the device is being compared to a legally marketed predicate device for "substantial equivalence."
• The study described is a clinical comparison between the new device (SeraQuest) and the predicate device (Shield Diastat). It's not a standalone performance study against a definitive gold standard like pathology in the typical sense for a diagnostic assay, but rather a comparison to an established, similar diagnostic.
• The acceptance criteria are implied by the reported performance (specifically the relative sensitivity and specificity compared to the predicate). There aren't explicitly stated "acceptance criteria" values the new device had to meet, but rather the performance it achieved relative to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

*Note: All percentages are relative to the Shield Diastat Anti-Sm/RNP test (the predicate device). The confidence intervals (CI) are important indicators of the precision of these estimates. The "acceptance criteria" are implied because the purpose of a 510(k) is to demonstrate substantial equivalence, meaning the new device performs comparably to the predicate. No explicit numerical targets for sensitivity, specificity, or agreement are stated.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 252 specimens.
• Data Provenance: Not explicitly stated (e.g., country of origin). The study design appears to be retrospective, as it involves testing a collection of "specimens" against two existing assays, one of which is a predicate. There's no indication of prospective patient enrollment based on the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not applicable in the traditional sense.

• Qualifications of Experts: Not applicable.

  Explanation: The "ground truth" for the test set in this study was established using the predicate device's results (Shield Diastat Anti-Sm/RNP test). The study is a comparison of the new device to the predicate, not an evaluation against an independent "expert consensus" or definitive clinical outcome. Therefore, there were no human experts establishing a distinct ground truth for the test set beyond the performance of the predicate device itself.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable.

  Explanation: Since the "ground truth" was based on the predicate device's results, there was no need for human adjudication of discrepancies between expert opinions or between an expert and the device. The comparison involved the new device's results directly against the predicate device's results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study Done: No.

  Explanation: This study is an in vitro diagnostic assay comparison, not an imaging or interpretation study involving human readers. Therefore, an MRMC study is not relevant to this type of device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance Done: Yes, in a way.

  Explanation: The SeraQuest Anti-Sm/RNP test is an enzyme immunoassay (EIA). Such assays, once performed, produce a quantitative result (Index value) that is then interpreted. The clinical testing described, comparing its results directly to the predicate device's results, represents its "standalone" performance for detecting antibodies. There's no human "interpretation" component of the device's output described that would require a human-in-the-loop study; the output itself is the diagnostic result.

7. The Type of Ground Truth Used

• Type of Ground Truth: The results of a legally marketed predicate device (Shield Diastat Anti-Sm/RNP test).

  Explanation: The study establishes the performance of the SeraQuest device by comparing its categorization (positive, equivocal, negative) against that of the predicate device.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not explicitly stated.

  Explanation: The document describes the "Summary of Clinical Testing" as a single study involving 252 specimens. It does not separate this into distinct "training" and "test" sets as one might for a machine learning model. For a traditional immunoassay, development and calibration (which might use a "training set" of sorts) would occur during the assay's design phase, but this clinical study appears to be a final validation. The calibrators developed "based on an in-house standard" likely involved a separate set of samples during development, but their size is not provided here.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not explicitly stated for a distinct training set in the context of this clinical evaluation.

  Explanation: The document mentions that "The Calibrators in the SeraQuest Anti-Sm/RNP test set have been assigned Index values based on an in-house standard." This implies that internal standards and a reference method were used during the development and calibration of the assay. However, the details of these standards, the specific samples used, or how their "ground truth" was established are not provided in this 510(k) summary. This typically involves established reference samples or characterized patient samples for assay development, but it's distinct from the clinical comparison study described for regulatory submission.

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