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510(k) Data Aggregation
(122 days)
BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK
Binax NOW® Flu A Test is an in vitro rapid immunochromatographic assay for the qualitative detection of influenza A nucleoprotein antigen in nasal wash and nasopharyngeal swab specimens from symptomatic patients. It is intended to aid in the rapid diagnosis of influenza A infections. Negative test results should be confirmed by cell culture.
The Binax NOW® Flu A Test is an immunochromatographic membrane assay used to detect influenza A nucleoprotein antigen in nasal wash and nasopharyngeal swab specimens. A test strip, containing goldconjugated and immobilized anti-influenza A antibodies, is mounted on the right side of a cardboard, book-shaped hinged test device. Swab specimens require a sample preparation step, in which the sample is eluted off the swab into a saline solution. The nasal wash sample does not require any preparation. The sample to be tested is added to a pad at the top of the test strip, and the test device is closed. Influenza A antigen present in the sample reacts to bind anti-influenza A conjugated antibody. The resulting antigenconjugate complexes are captured by immobilized anti-influenza A antibody, forming the Sample Line. Immobilized Control Line antibody, which appears as a blue line in an untested device, captures a visualizing conjugate, forming a pink Control Line. The sample is contained, and results are available within 15 minutes.
Here's an analysis of the provided text regarding the Binax NOW® Flu A Test, structured to address your specific questions:
Binax NOW® Flu A Test Study Analysis
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve sensitivity of X% and specificity of Y%"). Instead, it presents the device's performance characteristics. The acceptance of the device is implicitly based on its substantial equivalence to the predicate device (Quidel QuickVue® Influenza Test) and the presented clinical performance data.
| Performance Metric | Acceptance Criteria (Not explicitly stated, interpreted as "demonstrated performance") | Reported Device Performance (Binax NOW® Flu A Test) |
|---|---|---|
| Nasal Wash Specimens | - | Sensitivity: 82% (69% - 90% CI) |
| - | Specificity: 94% (89% - 97% CI) | |
| - | Overall Accuracy: 91% (86% - 94% CI) | |
| Nasopharyngeal Swab Specimens | - | Sensitivity: 78% (62% - 88% CI) |
| - | Specificity: 92% (86% - 95% CI) | |
| - | Overall Accuracy: 89% (84% - 93% CI) | |
| Analytic Reactivity | Detects all influenza A strains | 100% positive for 6 ATCC traceable influenza A strains |
| Analytic Specificity (Cross-Reactivity) | No cross-reactivity with common respiratory bacteria and viruses | No cross-reactivity with 42 potential cross-reactants |
| Reproducibility | Consistent results across sites and days | 100% correctly interpreted across 3 sites, 3 days |
| Interfering Substances | No interference from common nasal/nasopharyngeal substances | No interference with 19 substances, even when spiked with LOD virus |
| Quality Control | Procedural control indicates test failure | 100% correct interpretation (positive, negative, invalid) with 9 defective devices |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- 191 nasal wash specimens
- 182 nasopharyngeal swab specimens
- Data Provenance: Prospective clinical studies, multi-site. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting U.S.-based or internationally accepted clinical trials.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number or qualifications of experts used to establish the ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not mention an adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This study evaluated the performance of the device against a laboratory reference standard (viral cell culture), not human readers with or without AI assistance.
6. Standalone Performance (Algorithm Only)
Yes, a standalone performance study was done. The reported sensitivity, specificity, and accuracy values are for the Binax NOW® Flu A Test device on its own when compared to viral cell culture. There is no human-in-the-loop component described in these performance metrics.
7. Type of Ground Truth Used
The primary ground truth used for the clinical sensitivity and specificity evaluation was viral cell culture. This is a recognized laboratory standard for confirming influenza infections.
8. Sample Size for the Training Set
The document does not specify a training set sample size. This type of rapid diagnostic test typically does not involve a "training set" in the context of machine learning algorithms. The device's performance is established through its design, antibody selection, and validation against known positive and negative samples, rather than an iterative learning process on a large dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the machine learning sense, this question is not directly applicable. However, the device's design and analytical performance (reactivity, specificity) would have been developed and validated using characterized influenza A strains (e.g., ATCC traceable strains) and various potential cross-reactants, for which the ground truth (presence/absence of target, identity of organism) would be established by standard microbiological and virological methods.
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