Cleared Traditional

K102778 - CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION

K102778 is an FDA 510(k) clearance for CELLAVISION DM1200 WITH THE BODY FLUID ..., manufactured by CellaVision AB. The device is a Class 2 Hematology device with product code JOY cleared through the Traditional 510(k) pathway after a 357-day FDA review.

K102778 · CellaVision AB · Hematology device
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Sep 2011
Decision
357d
Days
Class 2
Risk

K102778 is an FDA 510(k) clearance for the CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION. Classified as Device, Automated Cell-locating (product code JOY), Class II - Special Controls.

Submitted by CellaVision AB (Fridley, US). The FDA issued a Cleared decision on September 16, 2011 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K102778

510(k) Number K102778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2010
Decision Date September 16, 2011
Days to Decision 357 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
244d slower than avg
Panel avg: 113d · This submission: 357d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOY Device Classification - Class 2, Special Controls

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 21
Devices cleared under the same product code (JOY) and FDA review panel - the closest regulatory comparables to K102778.
X100 with Full Field Peripheral Blood Smear (PBS) Application
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Advanced RBC Application
K171315 · CellaVision AB · Aug 2017
EASYCELL CELL LOCATOR
K092116 · Medica Corp. · May 2010
MODIFICATION TO DUET SYSTEM
K050840 · Bioview , Ltd. · Aug 2005
AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)
K984188 · Chroma Vision Medical Systems, Inc. · Jul 1999