Cleared Traditional

BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM (K023568) - FDA 510(k) Clearance

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

K023568 · Becton, Dickinson & CO · Microbiology device
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Jan 2003
Decision
92d
Days
Class 2
Risk

K023568 is an FDA 510(k) clearance for the BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM. 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 January 24, 2003 after a review of 92 days - within the typical 510(k) review window.

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.

View all Becton, Dickinson & CO devices

Submission Details

510(k) Number K023568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2002
Decision Date January 24, 2003
Days to Decision 92 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
10d faster than avg
Panel avg: 102d · This submission: 92d
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 K023568.
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NALIDIXIC ACID - 2-32 UG/ML
K030579 · Becton, Dickinson & CO · Mar 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE - 0.5-16 UG/ML
K024153 · Becton, Dickinson & CO · Feb 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - RIFAMPIN 0.25-32 UG/ML
K024152 · Becton, Dickinson & CO · Jan 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CIPROFLOXACIN GN
K023895 · Becton, Dickinson & CO · Jan 2003
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16UG/ML)
K023634 · Becton, Dickinson & CO · Dec 2002
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 UG/ML
K023527 · Becton, Dickinson & CO · Dec 2002