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510(k) Data Aggregation
(51 days)
SAS INFLUENZA B TEST
SAS™ Influenza B Test is a visual and rapid assay for the presumptive qualitative detection of Influenza Type B antigens from nasal washes and aspirates. Negative results should be confirmed via culture. This test is not intended for the detection of Influenza Type A or C viral antigen. The test is for professional use.
The SAS™ Influenza B test utilizes a set monoclonal antibodies against Influenza Type B viral nucleoproteins. The SAS™ Influenza test begins with an extraction of Type B nucleoproteins. After the extraction has been completed, the sample is placed into the test and observed for the formation of colored lines. The specimen is absorbed and migrates via capillary action through a membrane that contains dried gold conjugated antibody, which is specific for Influenza Type B nucleoproteins. If Type B nucleoproteins are present, a "half-sandwich" immuno-complex is formed. The membrane contains immobilized antibody to Influenza Type B nucleoproteins, which binds the "half sandwich" complex. Thus, in the presence of Influenza nucleoproteins, a "whole sandwich" immuno-complex is formed and a visible, pink colored line develops in the specimen zone of the test device. In the absence of an Influenza antigen, a "sandwich" immuno-complex is not formed and a negative result is indicated. To serve as a procedural control, a pink colored control line will always appear in the control zone regardless of the presence or absence of Influenza B nucleoproteins.
Acceptance Criteria and Study for SAS™ Influenza B Test
The provided document describes the SAS™ Influenza B Test, an immunoassay for the presumptive qualitative detection of Influenza Type B antigens. The primary study presented aims to demonstrate substantial equivalence to a predicate device, the Binax™ NOW® Flu B Test.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity, specificity, or positive/negative predictive values. Instead, the acceptance criterion appears to be demonstrating substantial equivalence to the predicate device. The performance summary indirectly addresses this by stating the device performed "substantially equivalent" when compared to the predicate using freshly collected nasal wash specimens.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance Statement |
|---|---|---|
| Equivalence | Substantial equivalence to predicate device (Binax™ NOW® Flu B Test) | "The SAS™ Influenza B test performed substantially equivalent to the predicate device, Binax™ NOW® Flu B test." |
| Cross-Reactivity | No interference or cross-reaction with common respiratory viral and bacterial strains. | "None of the organisms interfered or cross-reacted with the performance of the SAS™ Influenza B test." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document indicates that the comparison was made using "freshly collected nasal wash specimens." The exact number of specimens is not provided.
- Data Provenance: The data is described as using "freshly collected nasal wash specimens," implying the data is prospective in nature. The country of origin is not specified, but the submission is from SA Scientific, Inc. in San Antonio, TX, USA, suggesting the data is likely from the United States.
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 (e.g., expert consensus on images). Instead, the study's ground truth for comparison is likely derived from the predicate device's results, or potentially in conjunction with a more definitive method like viral culture, though culture is only mentioned for confirming negative results in the "Indications for Use."
4. Adjudication Method for the Test Set
No adjudication method is described. The study appears to be a direct comparison of the investigational device's results against the predicate device's results, or against a reference standard without mention of a formal adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a rapid immunoassay test, which typically provides a single, objective result (positive/negative) without requiring interpretation by multiple readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable to this type of device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study was done. The SAS™ Influenza B Test is a visual immunoassay that produces a direct result. Its performance is evaluated intrinsically through its ability to detect the target antigen, not as an algorithm assisting a human. The performance summary describes its direct comparison to the predicate device, indicating a standalone evaluation.
7. Type of Ground Truth Used
The primary ground truth for establishing substantial equivalence was likely the results from the predicate device (Binax™ NOW® Flu B Test) using the same "freshly collected nasal wash specimens." While the "Indications for Use" section states that "Negative results should be confirmed via culture," it's not explicitly stated that viral culture was used as the definitive ground truth for the equivalence study itself, but rather as a clinical follow-up for specific results.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable as this is a rapid immunoassay device, not a machine learning or AI algorithm. Therefore, no training set size is mentioned.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of device, this question is not applicable.
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