Cleared Traditional

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST (K033458) - FDA 510(k) Clearance

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

K033458 · Becton, Dickinson & CO · Microbiology device
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May 2004
Decision
211d
Days
Class 2
Risk

K033458 is an FDA 510(k) clearance for the BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST. Classified as System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (product code LON), Class II - Special Controls.

Submitted by Becton, Dickinson & CO (Sparks, US). The FDA issued a Cleared decision on May 28, 2004 after a review of 211 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1645 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K033458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2003
Decision Date May 28, 2004
Days to Decision 211 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
109d slower than avg
Panel avg: 102d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1645
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 Peers - LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

All 278
Devices cleared under the same product code (LON) and FDA review panel - the closest regulatory comparables to K033458.
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K041384 · Becton, Dickinson & CO · Aug 2004
VITEK 2 ESBL TEST
K040845 · bioMerieux, Inc. · Jun 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PENICILLIN (GP) 0.0625-32 UG/ML
K040716 · Becton, Dickinson & CO · May 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE
K033362 · Becton, Dickinson & CO · Apr 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5 - 16/304 UG/ML
K033907 · Becton, Dickinson & CO · Apr 2004