Cleared Traditional

DxFLEX Flow Cytometer (K232600) - FDA 510(k) Clearance

Also marketed or referenced as:
ClearLLab 10C Panels

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

K232600 · Beckman Coulter, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
86d
Days
Class 2
Risk

K232600 is an FDA 510(k) clearance for the DxFLEX Flow Cytometer. Classified as Flow Cytometric Reagents And Accessories. (product code OYE), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on November 22, 2023 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 864.5220 - 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.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K232600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2023
Decision Date November 22, 2023
Days to Decision 86 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 104d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OYE Flow Cytometric Reagents And Accessories.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
Definition To Identify And Classify Cells Or Other Particles In Suspension By Their Inherent Physical Properties Or Associated Fluorescent Molecules In Order To Provide Information About The Distribution Or Number Cells In Suspension Or Their Level Of Protein Expression. These Characteristics May Aid In The Diagnosis Of Conditions Such As Immunodeficiency And Cancer.
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 Immunology devices follow this clearance model.

Regulatory Peers - OYE Flow Cytometric Reagents And Accessories.

Devices cleared under the same product code (OYE) and FDA review panel - the closest regulatory comparables to K232600.
BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit
K201814 · Becton, Dickinson and Company · Sep 2020
BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK
K170974 · Becton, Dickinson and Company · Jul 2017
AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS
K141932 · Beckman Coulter, Inc. · Apr 2015
NAVIOS FLOW CYTOMETER SYSTEM
K130373 · Beckman Coulter, Inc. · Sep 2013
TETRACHROME REAGENTS AND TETRACXP SYSTEM
K121445 · Beckman Coulter, Inc. · Jul 2013