APAS Independence with Urine Analysis Module is an AI-enabled medical device from Clever Culture Systems AG that the U.S. FDA cleared through 510(k) K183648 on May 15, 2019. Its lead review panel is Microbiology and its primary product code is PPU (Microbial Colony Image Assessment System).
See also all FDA AI clearances in 2019.
Key facts
| Submission number | K183648 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Clever Culture Systems AG |
| Lead review panel | Microbiology |
| Primary product code | PPU — Microbial Colony Image Assessment System |
| Applicant (openFDA) | Clever Culture Systems AG |
| Applicant location | Bach, CH |
| Device class | Class 2 |
| Regulation number | 21 CFR 866.2190 |
| 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. APAS Independence with Urine Analysis Module went through this pathway (K183648).
openFDA lists it as a Class 2 device under 21 CFR 866.2190. Class II devices are moderate risk and are subject to general and special controls.
Product code PPU covers 2 devices on the FDA AI list. By decision date, this device is #1 of 2 under that code. Clever Culture Systems AG 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.