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510(k) Data Aggregation
(108 days)
The BinaxNOW® Influenza A & B Test is an in vitro immunochromatographic assay for the qualitative detection of influenza A and B nucleoprotein antigens in nasopharyngeal (NP) swab, nasal swab, and nasal wash/aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decision.
The BinaxNOW® Influenza A & B Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect influenza type A & B nucleoprotein antigens in respiratory specimens. These antibodies and a control antibody are immobilized onto a membrane support as three distinct lines and combined with other reagents/pads to construct a test strip. This test strip is mounted inside a cardboard, book-shaped hinged test device. Swab specimens require a sample preparation step, in which the sample is eluted off the swab into elution solution, saline, or transport media. Nasal wash/aspirate samples require no preparation. Sample is added to the top of the test strip and the test device is closed. Test results are interpreted at 15 minutes based on the presence or absence of pink-to-purple colored Sample Lines. The blue Control Line turns pink in a valid assay.
Here's a breakdown of the acceptance criteria and study details for the BinaxNOW® Influenza A & B Test, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for sensitivity and specificity are not explicitly stated as pre-defined targets within the provided text. Instead, the document presents the observed performance of the device against the reference method (cell culture/DFA) in various clinical studies. The substantial equivalence is established by comparing this observed performance to the predicate device, the BD Directigen™ Flu A+B Test (though detailed performance for the predicate is not provided in this summary).
For the purpose of this analysis, we will present the reported device performance from the prospective and retrospective clinical studies.
BinaxNOW® Influenza A & B Test Performance vs. Cell Culture/DFA (Prospective Study)
| Target | Sample Type | Reported Sensitivity (%) (95% CI) | Reported Specificity (%) (95% CI) |
|---|---|---|---|
| Influenza A | NP Swab | 77% (65-86%) | 99% (97-100%) |
| Nasal Swab | 83% (74-90%) | 96% (93-98%) | |
| Overall | 81% (74-86%) | 97% (96-98%) | |
| Influenza B | NP Swab | 50% (9-91%) | 100% (99-100%) |
| Nasal Swab | 69% (39-90%) | 100% (98-100%) | |
| Overall | 65% (39-85%) | 100% (99-100%) |
BinaxNOW® Influenza A & B Test Performance vs. Cell Culture/DFA (Retrospective Study)
| Target | Sample Type | Reported Sensitivity (%) (95% CI) | Reported Specificity (%) (95% CI) |
|---|---|---|---|
| Influenza A | NP Swab | 70% (50-86%) | 90% (81-95%) |
| Wash/Aspirate | 89% (78-96%) | 95% (89-98%) | |
| Overall | 83% (73-90%) | 93% (88-96%) | |
| Influenza B | NP Swab | N/A (0/0 positive) | 98% (93-100%) |
| Wash/Aspirate | 53% (27-78%) | 94% (89-97%) | |
| Overall | 53% (27-78%) | 96% (92-98%) |
Analytical Sensitivity (Limit of Detection - LOD)
| Influenza Strain | Concentration (ng/ml) | # Detected | % Detected |
|---|---|---|---|
| Flu A/Beijing (LOD) | 1.03 x 10^2 | 23/24 | 96% |
| Flu B/Harbin (LOD) | 6.05 x 10^1 | 23/24 | 96% |
2. Sample Sizes Used for the Test Set and Data Provenance
- Prospective Study Test Set:
- Total Specimens: 846
- Provenance: Multi-center, "central testing laboratory outside the US during the 2004 respiratory season and at three US trial sites during the 2005-2006 respiratory season." Data is prospective.
- Patient demographics: 44% male, 54% female, 54% pediatric (
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