Clinical Laboratory Evaluation Program
Notification to add FDA-approved influenza A / H1N1 tests
Public Health Laboratories seeking to offer influenza A / H1N1 testing using an FDA-approved Emergency Use Authorization (EUA) kit, only need to submit the Add/Delete Analyte form below, provided there are no modifications to the process, procedure or equipment, as detailed in the EUA. Laboratories need to ensure that their utilization of such an EUA kits is adherent to the "IV. Conditions of Authorization" in the FDA's Medical Device Emergency Authorization letter.
- List of FDA-approved EUA kits.
- Add/Delete Analyte form (fillable PDF - 88K)
Expedited approval of molecular assays for the detection of novel influenza A / H1N1 - Revised 11/09
Laboratories seeking to offer novel influenza A / H1N1 detection assays that have been developed and validated for use under public health emergencies can submit the assay for expedited approval using the guidelines, criteria, and algorithm listed below. Please note that such "Expedited approvals" are for non-Public Health Laboratories adapting an Emergency Use Authorization (EUA) protocol/kit.
- H1N1 Notification form (fillable PDF - 62K)
- NYSDOH Influenza Assay Validation Guidelines (PDF - 30K)
- Amended Result and Reporting for Expedited H1N1 (PDF - 21K)
- Novel H1N1 Resulting Algorithm (PDF - 80K)