# K201301: X100 with Full Field Peripheral Blood Smear (PBS) Application

- Pathway: 510(k) (Traditional)
- Applicant: Scopio Labs, Ltd.
- Decided: Oct 2, 2020 after 140 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: 4 generations back to K925670 (1993). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092116: Easycell Cell Locator, Medica Corp. (2010) Summary page 4.
- (no number) Romanowsky stain manual light microscope process for cell classification: named in the summary without a submission number

## Most influential descendants
- K220013: X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application (2022), 1 descendant of its own
- K243144: X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application (2025), 0 descendants of its own

## Indications for use
The X100 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/K201301
Methodology: https://510kreport.com/methodology