Cleared Traditional

K150815 - BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit (FDA 510(k) Clearance)

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

K150815 · Becton, Dickinson and Company · Immunology device
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Dec 2015
Decision
265d
Days
Class 2
Risk

K150815 is an FDA 510(k) clearance for the BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Ca.... Classified as Automated Multicolor Fluorescent Imaging Cytometric Analysis System (product code PMG), Class II - Special Controls.

Submitted by Becton, Dickinson and Company (San Jose, US). The FDA issued a Cleared decision on December 17, 2015 after a review of 265 days - an extended review 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: 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.

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Submission Details

510(k) Number K150815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2015
Decision Date December 17, 2015
Days to Decision 265 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
161d slower than avg
Panel avg: 104d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PMG Automated Multicolor Fluorescent Imaging Cytometric Analysis System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
Definition An Automated Multicolor Fluorescent Imaging Cytometer And Absorbance Spectrometer Which Utilizes Specific Single-use Reagent Cartridges To Identify And Enumerate Specific Hematologic Subpopulations And Parameters (e.g., Hemoglobin) Using Spectrophotometric Absorbance Measurement And Fluorescence Measurements.
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.