# K243144: X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application

- Pathway: 510(k) (Traditional)
- Applicant: Scopio Labs, Ltd.
- Decided: Jun 27, 2025 after 270 days
- Product code: JOY (Device, Automated Cell-Locating)
- Device class: 2
- Regulation: 21 CFR 864.5260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K925670 (1993). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201301: X100 with Full Field Peripheral Blood Smear (PBS) Application, Scopio Labs, Ltd. (2020) Summary page 6.
- K220013: X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application, Scopio Labs, Ltd. (2022) Summary page 6.

## Indications for use
The X100/X100HT with Full Field Peripheral Blood Smear Application is intended to locate and display images of white cells, red cells, and platelets acquired from fixed and stained peripheral blood smears and assists a qualified technologist in conducting a WBC differential, RBC morphology evaluation, and platelet estimate using those images. For in-vitro diagnostic use only. For professional use only.

Source page: https://510kreport.com/device/K243144
Methodology: https://510kreport.com/methodology