Cleared Traditional

K244044 - PBC Separator with Selux AST System (FDA 510(k) Clearance)

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

K244044 · Selux Diagnostics, Inc. · Microbiology device
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Mar 2025
Decision
88d
Days
Class 2
Risk

K244044 is an FDA 510(k) clearance for the PBC Separator with Selux AST System. Classified as Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing (product code QZX), Class II - Special Controls.

Submitted by Selux Diagnostics, Inc. (Charlestown, US). The FDA issued a Cleared decision on March 28, 2025 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1650 - the FDA microbiology 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 Selux Diagnostics, Inc. devices

Submission Details

510(k) Number K244044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2024
Decision Date March 28, 2025
Days to Decision 88 days
Submission Type Traditional
Review Panel Microbiology (MI)
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: 102d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QZX Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1650
Definition Processing Device That Includes Associated Reagents, When Applicable, That Is Intended To Recover Microbes From Positive Blood Cultures For Inoculum Preparation. The Prepared Inoculum Is Intended For Subsequent Use In Antimicrobial Susceptibility Testing.
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 Microbiology devices follow this clearance model.