Cleared Traditional

ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer (K183592) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence.

K183592 · Beckman Coulter · Immunology device
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Optimized for regulatory review, auditing and printing
Mar 2019
Decision
90d
Days
Class 2
Risk

K183592 is an FDA 510(k) clearance for the ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cy.... Classified as Flow Cytometric Test System For Hematopoietic Neoplasms (product code PWD), Class II - Special Controls.

Submitted by Beckman Coulter (Miami, US). The FDA issued a Cleared decision on March 21, 2019 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 864.7010 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Beckman Coulter devices

Submission Details

510(k) Number K183592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2018
Decision Date March 21, 2019
Days to Decision 90 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
14d faster than avg
Panel avg: 104d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PWD Flow Cytometric Test System For Hematopoietic Neoplasms
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7010
Definition Reagents Intended For In Vitro Diagnostic Use As A Panel For Qualitative Identification Of Cell Populations By Multiparameter Immunophenotyping On A Flow Cytometer. These Reagents Are Used As An Aid In The Differential Diagnosis Of Hematologically Abnormal Patients Having, Or Suspected Of Having The Following Hematopoietic Neoplasms: Chronic Leukemia, Acute Leukemia, Non-hodgkin's Lymphoma, Myeloma, Myelodysplastic Syndrome (mds), And/or Myeloproliferative Neoplasms (mpn)
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Immunology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03413644 Completed Observational Industry-sponsored

Evaluation of ClearLLab Leukemia and Lymphoma Panels

482
Patients (actual)
4
Sites
Condition studied Leukemia-Lymphoma
Eligibility All sexes
Principal investigator Adrian Padurean, MD
Sponsor Beckman Coulter, Inc. (industry)
Started 2017-11-14 → Primary completion 2018-04-27
Primary outcome
Hematologically Malignant or Non-Malignant
Study completed - no results published. This trial concluded in 2018 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov