Cleared Traditional

K260215 - BD OneFlow LST

Also marketed or referenced as:
BD OneFlow B-CLPD T1 BD FACSLyric Flow Cytometer, 8-color [4-2-2], 10-color [4-3-3], 12-color (4-3-5)

K260215 is an FDA 510(k) clearance for BD OneFlow LST, manufactured by Bd Biosciences. The device is a Class 2 Immunology device with product code PWD cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K260215 · Bd Biosciences · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
270d
Days
Class 2
Risk

K260215 is an FDA 510(k) clearance for the BD OneFlow LST. Classified as Flow Cytometric Test System For Hematopoietic Neoplasms (product code PWD), Class II - Special Controls.

Submitted by Bd Biosciences (Milpitas, US). The FDA issued a Cleared decision on October 20, 2026 after a review of 270 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K260215

510(k) Number K260215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2026
Decision Date October 20, 2026
Days to Decision 270 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
165d slower than avg
Panel avg: 105d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PWD Device Classification - Class 2, Special Controls

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

K260215 · BD OneFlow LST
Download PDF FDA Summary Bd Biosciences