Search Results

The OSOM® Influenza A&B Test is an in vitro diagnostic immunochromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections.

This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

The OSOM Influenza A&B Test consists of a test stick that separately detects influenza A and B. The test procedure requires the solubilization of the nucleoproteins from a swab by mixing the swab in Extraction Buffer. The test stick is then placed in the sample mixture, which then migrates along the membrane surface. If influenza A and/or B viral antigens are present in the sample, it will form a complex with mouse monoclonal IgG antibodies to influenza A and/or B nucleoproteins conjugated to colloidal gold. The complex will then be bound by another mouse anti-influenza A and/or B antibody coated on the nitrocellulose membrane. A pink to purple control line must appear in the control region of the stick for results to be valid. The appearance of a second and possibly a third light pink to purple line will appear in the test line region indicating an A, B or A and B positive result.

The provided text describes a 510(k) summary for the OSOM® Influenza A&B Test, primarily focusing on updating the package insert with additional analytical reactivity information for the H1N1 Influenza A strain Mexico/4108/2009.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for clinical performance. Instead, it demonstrates the device's analytical reactivity with a specific strain of influenza. The acceptance is based on the device showing reactivity to the H1N1 strain.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: The document refers to testing with a "cultured strain" (A/Mexico/4108/2009) of the 2009 H1N1 Influenza A virus. It does not specify a "sample size" in terms of number of patient samples, but rather indicates a single viral strain was used for this analytical reactivity test.
• Data Provenance: The data is analytical reactivity information, presumably from a laboratory setting. Specific country of origin is not mentioned for this particular test, but the strain name "Mexico/4108/2009" indicates the origin of the virus strain. The study is a prospective analytical study, not a retrospective clinical study.

3. Number of Experts and Qualifications

Not applicable. This was an analytical reactivity study, not a study requiring expert interpretation of results. The determination of whether the test "reacts" is a direct laboratory observable.

4. Adjudication Method

Not applicable. There was no need for adjudication as this was an analytical reactivity study, not a clinical study involving multiple interpreters.

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

No. The document describes an analytical reactivity study, not a clinical effectiveness study. There is no mention of human readers or AI assistance.

6. Standalone Performance Study

Yes. The study described is a standalone analytical performance study, demonstrating the device's ability to detect the H1N1 strain in a cultured sample without human intervention in the result interpretation (beyond observing the test line).

7. Type of Ground Truth Used

The ground truth used was the cultured presence of the specific H1N1 Influenza A virus strain (A/Mexico/4108/2009). This is a laboratory-established ground truth.

8. Sample Size for the Training Set

Not applicable. This device is an immunochromatographic assay, not an AI/machine learning algorithm, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device