Cleared Traditional

K171315 - Advanced RBC Application

K171315 is an FDA 510(k) clearance for Advanced RBC Application, 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 89-day FDA review.

K171315 · CellaVision AB · Hematology device
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Aug 2017
Decision
89d
Days
Class 2
Risk

K171315 is an FDA 510(k) clearance for the Advanced RBC Application. Classified as Device, Automated Cell-locating (product code JOY), Class II - Special Controls.

Submitted by CellaVision AB (Lund, SE). The FDA issued a Cleared decision on August 1, 2017 after a review of 89 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all CellaVision AB devices

FDA 510(k) Submission Details - K171315

510(k) Number K171315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2017
Decision Date August 01, 2017
Days to Decision 89 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 113d · This submission: 89d
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 Consultant

C. G. Bundy, LLC
Constance G. Bundy

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JOY Device, Automated Cell-locating

All 20
Devices cleared under the same product code (JOY) and FDA review panel - the closest regulatory comparables to K171315.
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
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