UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM is an AI-enabled medical device from BECKMAN COULTER, INC. that the U.S. FDA cleared through 510(k) K120771 on March 22, 2013. Its lead review panel is Hematology and its primary product code is GKZ (Counter, Differential Cell).
See also top hematology AI devices.
Key facts
| Submission number | K120771 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | BECKMAN COULTER, INC. |
| Lead review panel | Hematology |
| Primary product code | GKZ — Counter, Differential Cell |
| Applicant (openFDA) | Beckman Coulter, Inc. |
| Applicant location | Miami, FL, US |
| Device class | Class 2 |
| Regulation number | 21 CFR 864.5220 |
| Decision code | SESE |
| Submission type | Abbreviated |
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. UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM went through this pathway (K120771).
openFDA lists it as a Class 2 device under 21 CFR 864.5220. Class II devices are moderate risk and are subject to general and special controls.
Product code GKZ covers 5 devices on the FDA AI list. By decision date, this device is #1 of 5 under that code. BECKMAN COULTER, INC. has 1 AI-enabled device on the list, and the Hematology panel accounts for 22 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.