# K171315: Advanced RBC Application

- Pathway: 510(k) (Traditional)
- Applicant: CellaVision AB
- Decided: Aug 1, 2017 after 89 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.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033840: Cellavision DM96 Automatic Hematology Analyzer, CellaVision AB (2004) Summary page 4.
- K092868: Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127, CellaVision AB (2009) Summary page 4.
- (no number) Romanowsky stain manual light microscope process for cell classification: named in the summary without a submission number

## Indications for use
The CellaVision DM1200 with the Advanced RBC Application is an automated cell-locating device. intended for in-vitro The CellaVision DM1200 with the Advanced RBC Application automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The CellaVision DM1200 with the Advanced RBC Application is intended for blood samples that have been flagged as abnormal by an automated cell counter. The CellaVision DM1200 with the Advanced RBC Application is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells. The CellaVision DM96 with the Advanced RBC Application is an automated cell-locating device, intended for in-vitro The CellaVision DM96 with the Advanced RBC Application automatically locates and presents images of blood cells on peripheral blood smears. The operator identifies and verifies the suggested classification of each cell according to type. The CellaVision DM96 with the Advanced RBC Application is intended for blood samples that have been flagged as abnormal by an automated cell counter. The CellaVision DM96 with the Advanced RBC Application is intended to be used by skilled operators, trained in the use of the device and in recognition of blood cells.

Source page: https://510kreport.com/device/K171315
Methodology: https://510kreport.com/methodology