Cleared Traditional

K031601 - MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML)

K031601 is an FDA 510(k) clearance for MICROSCAN SYNERGIES PLUS GRAM NEGATIVE ..., manufactured by Dade Behring, Inc.. The device is a Class 2 Microbiology device with product code LON cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K031601 · Dade Behring, Inc. · Microbiology device
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Apr 2004
Decision
317d
Days
Class 2
Risk

K031601 is an FDA 510(k) clearance for the MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5.... Classified as System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (product code LON), Class II - Special Controls.

Submitted by Dade Behring, Inc. (West Sacramento, US). The FDA issued a Cleared decision on April 2, 2004 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Dade Behring, Inc. devices

FDA 510(k) Submission Details - K031601

510(k) Number K031601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2003
Decision Date April 02, 2004
Days to Decision 317 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
215d slower than avg
Panel avg: 102d · This submission: 317d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LON Device Classification - Class 2, Special Controls

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 281
Devices cleared under the same product code (LON) and FDA review panel - the closest regulatory comparables to K031601.
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
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM
K040099 · Becton, Dickinson & CO · Mar 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -- AMPICILLIN -- GRAM POSITIVE
K040106 · Becton, Dickinson & CO · Mar 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/ML
K032675 · Becton, Dickinson & CO · Mar 2004