Cleared Special

K050191 - MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE (FDA 510(k) Clearance)

Class I Hematology device.

K050191 · Becton, Dickinson & CO · Hematology device
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Feb 2005
Decision
26d
Days
Class 1
Risk

K050191 is an FDA 510(k) clearance for the MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE. Classified as Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis (product code PER), Class I - General Controls.

Submitted by Becton, Dickinson & CO (San Jose, US). The FDA issued a Cleared decision on February 22, 2005 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.2750 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K050191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2005
Decision Date February 22, 2005
Days to Decision 26 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 113d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PER Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
Definition Flow Cytometer Specimen Processors Are Automated Or Semi-automated Workstations Designed To Be Used Alone Or In Combination With Manual Methods To Pipette, Dilute And Process Human Specimens In Preparation For Flow Cytometric Analysis.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.