Cleared Special

K121445 - TETRACHROME REAGENTS AND TETRACXP SYSTEM (FDA 510(k) Clearance)

Class II Hematology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K121445 · Beckman Coulter, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Jul 2013
Decision
437d
Days
Class 2
Risk

K121445 is an FDA 510(k) clearance for the TETRACHROME REAGENTS AND TETRACXP SYSTEM. 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 July 26, 2013 after a review of 437 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K121445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2012
Decision Date July 26, 2013
Days to Decision 437 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
324d slower than avg
Panel avg: 113d · This submission: 437d
Pathway characteristics
Modification to existing cleared device.

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 Hematology devices follow this clearance model.

Regulatory Peers - OYE Flow Cytometric Reagents And Accessories.

All 7
Devices cleared under the same product code (OYE) and FDA review panel - the closest regulatory comparables to K121445.
DxFLEX Flow Cytometer
K232600 · Beckman Coulter, Inc. · Nov 2023
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