# K200595: CellaVision DC-1, CellaVision DC-1 PPA

- Pathway: 510(k) (Traditional)
- Applicant: CellaVision AB
- Decided: Oct 16, 2020 after 224 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.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092868: Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127, CellaVision AB (2009) Summary page 8.

## Most influential descendants
- K221309: AI100 with Shonit (2023), 0 descendants of its own

## Indications for use
Intended use of CellaVision® DC-1 CellaVision® DC-1 is an automated cell-locating device intended for in-vitro diagnostic use in clinical laboratories. CellaVision® DC-1 1s intended to be used by operators, trained in the use of the device. Intended use of the Peripheral Blood Application The Peripheral Blood Application is intended for differential count of white blood cells (WBC), charactenization of red blood cell (RBC) morphology and platelet estimation. The CellaVision® DC-1 with the Peripheral Blood Application automatically locates blood cells on peripheral blood (PB) smears. The application presents images of the blood cells for review. A skilled operator trained in recognition of blood cells, identifies and venifies the suggested classification of each cell according to type.

Source page: https://510kreport.com/device/K200595
Methodology: https://510kreport.com/methodology