(111 days)
The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis.
For use to detect the presence of rotavirus in stool specimens from patients with loose stools, diarrhea, gastroenteritis, or suspected to be infected with rotavirus.
The ImmunoCard STAT! Rotavirus assay system is a membrane based immunogold assay for rotavirus. Each kit contains the following components: ImmunoCard STAT! Rotavirus devices(30), Positive Control (1.8ml), Sample Diluent (10.5ml), Transfer Pipets (30). In brief, 1/15 diluted stool enters the sample application pad and migrates through the conjugate pad. Monoclonal antibody (conjugated to colloidal gold particles) contained in the pad is dissolved in the specimen and travels onto the nitrocellulose membrane. The nitrocellulose membrane contains two "capture" zones. The first holds polyclonal antibody to rotavirus, and the second has polyclonal anti-mouse IgG. The first zone serves as the test line, indicating the presence of rotavirus. The second zone acts as a procedural control and verifies that the sample has migrated sufficiently into the device to permit a valid test result to be read in the first (test) zone. The final absorbent pad acts as a reservoir and draws the sample through the test strip.
{
"1. A table of acceptance criteria and the reported device performance": {
"Performance vs Electron Microscopy": {
"Acceptance Criteria": "Not explicitly stated as numerical criteria, but implied to be comparable to predicate devices.",
"Sensitivity": "93.1%",
"Specificity": "95.8%",
"Correlation": "94.4%"
},
"Performance vs Premier Rotaclone (Predicate Device)": {
"Acceptance Criteria": "Not explicitly stated as numerical criteria, but implied demonstration of substantial equivalence.",
"Sensitivity": "97.7%",
"Specificity": "100.0%",
"Correlation": "98.8%"
},
"Sensitivity Limits": {
"Acceptance Criteria": "Not explicitly stated as numerical criteria.",
"Reported Performance": "Approximately 1.8-3.7 x 10^6 viral particles."
},
"Reproducibility": {
"Acceptance Criteria": "Not explicitly stated as numerical criteria.",
"Reported Performance": "100% on controls, negative and moderate positive stools, and 96% on low positive stools."
},
"Cross-Reactivity": {
"Acceptance Criteria": "No false positive or false negative results with a panel of bacteria and viruses.",
"Reported Performance": "Met the criteria: gave no false positive or false negative results."
},
"Interfering Substances": {
"Acceptance Criteria": "Barium sulfate should not have an effect. High levels of blood may affect flow, potentially causing an occasional invalid result.",
"Reported Performance": "No effect from barium sulfate. High levels (≥33%) of blood could affect flow, resulting in an occasional invalid test result (consistent with criteria)."
}
},
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The sample size for the clinical test set is not explicitly stated in the provided text. The data provenance (country of origin, retrospective or prospective) is also not specified.",
"3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "Not applicable/Not specified. The ground truth for the core performance evaluation was established using Electron Microscopy and a predicate device (Premier Rotaclone), not necessarily human expert consensus for individual case adjudication.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable/Not specified. The performance was referenced against Electron Microscopy and a predicate device, not human adjudication of a test set.",
"5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": "Not applicable. This is an in vitro diagnostic device, not an AI-assisted diagnostic tool for human readers.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Yes, the device performance metrics (sensitivity, specificity, correlation) are presented as standalone performance evaluations against Electron Microscopy and a predicate device, indicating algorithm-only performance.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The primary ground truth used for performance comparison was **Electron Microscopy**. A second comparison was also made against the **Premier Rotaclone** predicate device.",
"8. The sample size for the training set": "Not applicable. For this type of in vitro diagnostic device (immunoassay), there isn't typically a 'training set' in the machine learning sense. The device's capture and detection antibodies are developed and optimized through laboratory work, not by 'training' on a dataset.",
"9. How the ground truth for the training set was established": "Not applicable, as there is no traditional 'training set' for this immunoassay device."
}
§ 866.3405 Poliovirus serological reagents.
(a)
Identification. Poliovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to poliovirus in serum. Additionally, some of these reagents consist of poliovirus antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify polioviruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of poliomyelitis (polio) and provides epidemiological information on this disease. Poliomyelitis is an acute infectious disease which in its serious form affects the central nervous system resulting in atrophy (wasting away) of groups of muscles, ending in contraction and permanent deformity.(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.