(106 days)
The BD Veritor™ System for Rapid Detection of Respiratory Syncytial Virus (RSV) is a chromatographic immunoassay with an instrumented read for the direct and qualitative detection of RSV fusion protein from nasopharyngeal washes/aspirates and nasopharyngeal swabs in transport media from patients suspected of having a viral respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and pediatric patients under the age of 20 years. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by viral cell culture or an alternative method, such as a FDA-cleared molecular assay. The test is intended for professional and laboratory use. It is to be used in conjunction with the BD Veritor ™ System Reader.
The BD RSV test is a chromatographic assay to qualitatively detect RSV fusion protein in samples processed from respiratory specimens. The processed specimen is added to the test device where RSV viral antigens bind to anti-RSV antibodies conjugated to detector particles on the RSV test strip. The antigen-conjugate complex migrates across the test strip to the reaction area and is captured by an antibody line on the membrane. Results are interpreted by the BD Veritor™ System Reader, a portable electronic device which uses a reflectance-based measurement method to evaluate the line signal intensities on the assay test strip, and applies specific algorithms to determine the presence or absence of any target analyte(s). A liquid crystal display (LCD) on the instrument communicates the results to the operator.
Here's a breakdown of the acceptance criteria and study details for the BD Veritor™ System for Rapid Detection of RSV, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as a separate table. However, based on the clinical study results and comparisons, the implicit criteria are high sensitivity and specificity relative to viral cell culture.
| Metric | Acceptance Criteria (Implicit from Context - comparable to predicate/clinical needs) | Reported Device Performance (BD Veritor™ System for RSV) |
|---|---|---|
| Clinical Performance (NPS) | High sensitivity and specificity acceptable for an aid in diagnosis | Sensitivity: 88.4% (95% CI: 82.8%, 92.4%) |
| Specificity: 98.3% (95% CI: 96.8%, 99.1%) | ||
| Clinical Performance (NPWA) | High sensitivity and specificity acceptable for an aid in diagnosis | Sensitivity: 91.6% (95% CI: 86.3%, 94.9%) |
| Specificity: 94.5% (95% CI: 91.2%, 96.7%) | ||
| Analytical Sensitivity (LOD) - Viral Strain VR-26 (Long Subgroup A) | Low concentration producing ≥95% positivity | $1.43 \times 10^5$ TCID50/mL (95.0% positive) |
| Analytical Sensitivity (LOD) - Viral Strain VR-955 (9320 subgroup B) | Low concentration producing ≥95% positivity | $3.98 \times 10^4$ TCID50/mL (95.0% positive) |
| Analytical Sensitivity (LOD) - Viral Strain VR-1540 (A-2) | Low concentration producing ≥95% positivity | $1.94 \times 10^3$ TCID50/mL (98.3% positive) |
| Analytical Sensitivity (LOD) - Viral Strain VR-1580 (Washington subgroup B) | Low concentration producing ≥95% positivity | $1.08 \times 10^4$ TCID50/mL (96.7% positive) |
| Analytical Sensitivity (LOD) - Viral Strain VR-1400 (Wild Type subgroup B) | Low concentration producing ≥95% positivity | $2.96 \times 10^3$ TCID50/mL (95.0% positive) |
| Analytical Specificity (Cross-Reactivity) | No cross-reactivity with common respiratory pathogens and flora | None showed cross-reactivity with tested microorganisms |
| Interfering Substances | No interference with tested substances | No interference noted for any of the tested substances |
| Media Compatibility | No interference or compatibility issues with common transport media | No interference or compatibility issues seen with tested media |
| Reproducibility | Consistent results across sites and operators | High consistency for moderate and negative samples, acceptable for low positive samples (e.g., Moderate positive RSV: 100% (90/90) total positive) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 1146 prospectively collected specimens.
- 440 Nasopharyngeal Wash / Aspirates (NPWA)
- 706 Nasopharyngeal Swabs (NPS)
- Data Provenance: From five U.S. trial sites during the 2011-2012 respiratory season. The data is prospective, as indicated by "prospectively collected specimens."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number or qualifications of experts used to establish the ground truth. It states that the ground truth was "an FDA cleared D3 Duet™ DFA on R-Mix cell culture," which is a laboratory method, not directly human experts.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance (or in this case, instrumented read) was not explicitly described. This is a point-of-care diagnostic device with an instrumented reader, not an AI for image analysis where human readers' performance might be augmented. The device itself performs the interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, this study represents a standalone evaluation of the device. The BD Veritor™ System for Rapid Detection of RSV test is an "instrumented read" system where the results are "interpreted by the BD Veritor™ System Reader... [which] applies specific algorithms to determine the presence or absence of any target analyte(s)." The clinical study compares this instrument's performance directly against the reference method (viral cell culture), indicating a standalone assessment.
7. The Type of Ground Truth Used
The primary ground truth used was viral cell culture (specifically, an "FDA cleared D3 Duet™ DFA on R-Mix cell culture"). For some discrepant results (BD Veritor RSV Positive, Viral Cell Culture negative specimens), an "FDA cleared Prodesse Pro Flu+ molecular assay" was used as a secondary confirmation method.
8. The Sample Size for the Training Set
The document does not specify a separate training set size. The device uses "pre-set thresholds" and "specific algorithms" but the development and training details for these algorithms are not provided in this summary. The clinical study described is for validation/testing, not training.
9. How the Ground Truth for the Training Set Was Established
Since a dedicated training set is not explicitly mentioned, the method for establishing ground truth for any internal algorithm development (if applicable) is not detailed in this 510(k) summary. The provided performance data pertains to the validation of the final device.
§ 866.3480 Respiratory syncytial virus serological reagents.
(a)
Identification. Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.