Accelerate Pheno System, Accelerate PhenoTest BC Kit is an AI-enabled medical device from Accelerate Diagnostics, Inc. that the U.S. FDA cleared through 510(k) K192665 on September 15, 2020. Its lead review panel is Microbiology and its primary product code is PRH (Positive Blood Culture Identification And Ast Kit).
See also all FDA AI clearances in 2020.
Key facts
| Submission number | K192665 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Accelerate Diagnostics, Inc. |
| Lead review panel | Microbiology |
| Primary product code | PRH — Positive Blood Culture Identification And Ast Kit |
| Applicant (openFDA) | Accelerate Diagnostics, Inc. |
| Applicant location | Tucson, AZ, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 866.1650 |
| 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. Accelerate Pheno System, Accelerate PhenoTest BC Kit went through this pathway (K192665).
openFDA lists it as a Class 2 device under 21 CFR 866.1650. Class II devices are moderate risk and are subject to general and special controls.
Product code PRH covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Accelerate Diagnostics, 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.