(26 days)
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 an update to the package insert of the OSOM® Influenza A&B Test (K092633) to include additional analytical reactivity information for specific H3N2v Influenza A strains. It is not an original submission for a new device, but rather a modification to an already cleared device. As such, the information typically found in an initial 510(k) for device performance and clinical studies demonstrating efficacy for establishing acceptance criteria and proving they are met is largely absent in this document.
However, based on the provided text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here is the ability of the OSOM® Influenza A&B Test to react with and detect specific influenza A strains. The stated performance is that the device does react with these strains.
| Acceptance Criteria (Ability to Detect) | Reported Device Performance |
|---|---|
| A/WEST VIRGINIA/06/2011 (H3N2v) | Reacts with and is detectable (Estimated detectable limit: 1.0E+05 EID50/mL*) |
| A/PENNSYLVANIA/14/2010 (H3N2v) | Reacts with and is detectable (Estimated detectable limit: 1.0E+08 EID50/mL*) |
| A/MINNESOTA/11/2010 (H3N2v) | Reacts with and is detectable (Estimated detectable limit: 1.0E+08 EID50/mL*) |
| A/KANSAS/13/2009 (H3N2v) | Reacts with and is detectable (Estimated detectable limit: 1.0E+05 EID50/mL*) |
| A/INDIANA/08/2011 (H3N2v) | Reacts with and is detectable (Estimated detectable limit: 1.0E+06 EID50/mL*) |
| A/INDIANA/10/2011 (H3N2v) | Reacts with and is detectable (Estimated detectable limit: 1.00E+09 EID50/mL*) |
Note: The document specifies that "the performance characteristics of this device with clinical specimens that are positive for these 2009 H1N1 and H3N2v influenza viruses have not been established." This indicates these results are from analytical reactivity studies, not clinical performance studies.
2. Sample Size Used for the Test Set and Data Provenance
The test set consisted of cultured strains of the H3N2v Influenza A virus. The specific sample size (i.e., number of replicates for each strain) is not provided.
The data provenance is from analytical testing (e.g., in vitro laboratory testing) of cultured strains of the H3N2v influenza A virus. The origin of the data is not explicitly stated as a country, but the strains themselves suggest a US origin (West Virginia, Pennsylvania, Minnesota, Kansas, Indiana). The study is retrospective in the sense that the strains were already cultured and tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/provided in the document as the study described is an analytical reactivity study using cultured viral strains. The "ground truth" for the test set is the known presence and concentration of the specific influenza virus strains in the cultured samples.
4. Adjudication Method for the Test Set
This information is not applicable/provided as this was an analytical reactivity study, not a clinical study involving human interpretation of results requiring adjudication. The device's reaction (detectable or not) is a direct output.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done for this submission. The submission pertains to updating analytical reactivity information for an already cleared in vitro diagnostic device, not evaluating human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance evaluation was done. The OSOM® Influenza A&B Test is an immunochromatographic assay, which is a rapid diagnostic test that provides a visual result (appearance of a pink to purple line). Its performance in detecting the H3N2v strains was evaluated directly, without human interpretation in the loop beyond observing the presence or absence of the test line.
7. The Type of Ground Truth Used
The ground truth used was the known presence and estimated concentration (EID50/mL or TCID50/mL) of specific cultured influenza A viral strains, often provided by sources like the CDC. This is a form of analytical truth based on established viral culture and quantification methods.
8. The Sample Size for the Training Set
This information is not applicable/provided. The detailed analytical reactivity described is for the test set that demonstrates the device's updated capabilities. For an already cleared device, detailed training set information for its initial development and clearance (K092633) is not part of this specific submission to update labeling. The OSOM® Influenza A&B Test is a lateral flow immunoassay, not a machine learning algorithm, so the concept of a "training set" in the computational sense does not apply. If "training set" refers to samples used during the original development and optimization of the assay, that information is not present here.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided for the reasons stated in point 8.
§ 866.3330 Influenza virus serological reagents.
(a)
Identification. Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.(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 the limitations in § 866.9.