Cleared Traditional

DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER (K003301) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K003301 · CellaVision AB · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
146d
Days
Class 2
Risk

K003301 is an FDA 510(k) clearance for the DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER. Classified as Device, Automated Cell-locating (product code JOY), Class II - Special Controls.

Submitted by CellaVision AB (Minneapolis,, US). The FDA issued a Cleared decision on March 15, 2001 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5260 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all CellaVision AB devices

Submission Details

510(k) Number K003301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2000
Decision Date March 15, 2001
Days to Decision 146 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 113d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOY Device, Automated Cell-locating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5260
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - JOY Device, Automated Cell-locating

All 34
Devices cleared under the same product code (JOY) and FDA review panel - the closest regulatory comparables to K003301.
X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application
K243144 · Scopio Labs , Ltd. · Jun 2025
AI100 with Shonit
K221309 · Sigtuple Technologies Pvt. , Ltd. · Sep 2023
X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application
K220013 · Scopio Labs , Ltd. · May 2022
CellaVision DC-1, CellaVision DC-1 PPA
K200595 · CellaVision AB · Oct 2020
X100 with Full Field Peripheral Blood Smear (PBS) Application
K201301 · Scopio Labs , Ltd. · Oct 2020
Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
K182062 · Sysmex America, Inc. · Oct 2018