# K003301: Diffmaster Octavia Automatic Hematology Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: CellaVision AB
- Decided: Mar 15, 2001 after 146 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: 1 generation back to K925670 (1993). 1 ancestor in all.
12 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925670: IMS-200, Intelligent Medica Imaging, Inc. (1993) Summary page 1.
- (no number) Romanowski (MGG)-Stain manual light microscopic process for cell classification: named in the summary without a submission number

## Most influential descendants
- K033840: Cellavision DM96 Automatic Hematology Analyzer (2004), 11 descendants of its own
- K092868: Cellavision DM1200 Automated Hematology Analyzer, Model XU-10127 (2009), 4 descendants of its own
- K092116: Easycell Cell Locator (2010), 3 descendants of its own
- K201301: X100 with Full Field Peripheral Blood Smear (PBS) Application (2020), 2 descendants of its own
- K220013: X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application (2022), 1 descendant of its own

## Indications for use
The DiffMaster Octavia™ is an automated cell locating device. DiffMaster Octavia automatically locates and presents images of blood cells on peripheral blood specimens. The operator identifies and verifies the suggested classification of each cell according to type. DiffMaster Octavia is intended to bc used by skilled operators, trained in the use of the instrument and in recognition of leukocyte classes.

Source page: https://510kreport.com/device/K003301
Methodology: https://510kreport.com/methodology