FluChip-8G Influenza A+B Assay is an AI-enabled medical device from InDevR, Inc. that the U.S. FDA cleared through 510(k) K182513 on April 22, 2019. Its lead review panel is Microbiology and its primary product code is OZE (Influenza A And Influenza B Multiplex Nucleic Acid Assay).
See also all FDA AI clearances in 2019.
Key facts
| Submission number | K182513 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | InDevR, Inc. |
| Lead review panel | Microbiology |
| Primary product code | OZE — Influenza A And Influenza B Multiplex Nucleic Acid Assay |
| Applicant (openFDA) | Indevr, Inc. |
| Applicant location | Boulder, CO, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 866.3980 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. FluChip-8G Influenza A+B Assay went through this pathway (K182513).
openFDA lists it as a Class 2 device under 21 CFR 866.3980. Class II devices are moderate risk and are subject to general and special controls.
Product code OZE covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. InDevR, Inc. has 1 AI-enabled device on the list, and the Microbiology panel accounts for 7 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.