Cleared Traditional

K131301 - BD FACS SAMPLE PREP ASSISTANT III (FDA 510(k) Clearance)

Class I Immunology device.

K131301 · Becton, Dickinson & CO · Immunology device
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Aug 2013
Decision
87d
Days
Class 1
Risk

K131301 is an FDA 510(k) clearance for the BD FACS SAMPLE PREP ASSISTANT III. 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 August 2, 2013 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.2750 - the FDA immunology 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.

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Submission Details

510(k) Number K131301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2013
Decision Date August 02, 2013
Days to Decision 87 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 104d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

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.