Cleared Traditional

K032153 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTE...

K032153 is the FDA 510(k) clearance for BD PHOENIX AUTOMATED MICROBIOLOGY SYSTE... by Bd Diagnostic Systems. It is a Class 2 Microbiology device (product code LON) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K032153 · Bd Diagnostic Systems · Microbiology device
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Sep 2003
Decision
59d
Days
Class 2
Risk

K032153 is an FDA 510(k) clearance for the BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/ML. Classified as System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (product code LON), Class II - Special Controls.

Submitted by Bd Diagnostic Systems (Sparks, US). The FDA issued a Cleared decision on September 11, 2003 after a review of 59 days - a notably fast clearance 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: 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 Bd Diagnostic Systems devices

Submission Details

510(k) Number K032153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2003
Decision Date September 11, 2003
Days to Decision 59 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 102d · This submission: 59d
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 282
Devices cleared under the same product code (LON) and FDA review panel - the closest regulatory comparables to K032153.
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS
K032275 · Becton, Dickinson & CO · Sep 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML
K032299 · Becton, Dickinson & CO · Sep 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE
K032567 · Becton, Dickinson & CO · Sep 2003
VITEK 2 GRAM POSITIVE MOXIFLOXACIN
K032399 · bioMerieux, Inc. · Sep 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML
K031984 · Becton, Dickinson & CO · Aug 2003
VITEK 2 GRAM POSITIVE GATIFLOXACIN
K032314 · bioMerieux, Inc. · Aug 2003