Cleared Traditional

K223493 - 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.

K223493 · Selux Diagnostics, Inc. · Microbiology device
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Feb 2024
Decision
451d
Days
Class 2
Risk

K223493 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 February 15, 2024 after a review of 451 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Microbiology submissions.

View all Selux Diagnostics, Inc. devices

Submission Details

510(k) Number K223493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2022
Decision Date February 15, 2024
Days to Decision 451 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
349d slower than avg
Panel avg: 102d · This submission: 451d
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.

Regulatory Consultant

Pbo Consulting
Carrene Plummer

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.