ACR LAB Urine Analysis Test System is an AI-enabled medical device from Healthy.io Ltd that the U.S. FDA cleared through 510(k) K182384 on July 26, 2019. Its lead review panel is Clinical Chemistry and its primary product code is JFY (Enzymatic Method, Creatinine).
See also all FDA AI clearances in 2019.
Key facts
| Submission number | K182384 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Healthy.io Ltd |
| Lead review panel | Clinical Chemistry |
| Primary product code | JFY — Enzymatic Method, Creatinine |
| Applicant (openFDA) | Healthy.Io, Ltd. |
| Applicant location | Tel Aviv, IL |
| Device class | Class 2 |
| Regulation number | 21 CFR 862.1225 |
| 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. ACR LAB Urine Analysis Test System went through this pathway (K182384).
openFDA lists it as a Class 2 device under 21 CFR 862.1225. Class II devices are moderate risk and are subject to general and special controls.
Product code JFY covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Healthy.io Ltd has 4 AI-enabled devices on the list, and the Clinical Chemistry panel accounts for 9 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.