Cleared Traditional

K010418 - DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS

K010418 is an FDA 510(k) clearance for DRIED GRAM-NEGATIVE AND GRAM-POSITIVE M..., manufactured by Dade Behring, Inc.. The device is a Class 2 Microbiology device with product code LTT cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K010418 · Dade Behring, Inc. · Microbiology device
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Aug 2001
Decision
191d
Days
Class 2
Risk

K010418 is an FDA 510(k) clearance for the DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS. Classified as Panels, Test, Susceptibility, Antimicrobial (product code LTT), Class II - Special Controls.

Submitted by Dade Behring, Inc. (West Sacramento, US). The FDA issued a Cleared decision on August 22, 2001 after a review of 191 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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 Dade Behring, Inc. devices

FDA 510(k) Submission Details - K010418

510(k) Number K010418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2001
Decision Date August 22, 2001
Days to Decision 191 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
89d slower than avg
Panel avg: 102d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LTT Device Classification - Class 2, Special Controls

Product Code LTT Panels, Test, Susceptibility, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
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 - LTT Panels, Test, Susceptibility, Antimicrobial

All 48
Devices cleared under the same product code (LTT) and FDA review panel - the closest regulatory comparables to K010418.
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN
K020160 · Dade Behring, Inc. · Mar 2002
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K013368 · Trek Diagnostic Systems, Inc. · Nov 2001
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES
K013195 · Trek Diagnostic Systems, Inc. · Nov 2001
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K010159 · Dade Microscan, Inc. · Jul 2001
PASCO MIC AND MIC/ID PANELS INCLUSION OF ESBL CONFIRMATORY TEST
K011116 · Pasco Laboratories, Inc. · Apr 2001
PASCO MIC AND MIC/ID PANELS
K010508 · Pasco Laboratories, Inc. · Apr 2001