Cleared Traditional

K010418 - DRIED GRAM-NEGATIVE AND GRAM-POSITIVE M...

K010418 is the FDA 510(k) clearance for DRIED GRAM-NEGATIVE AND GRAM-POSITIVE M... by Dade Behring, Inc.. It is a Class 2 Microbiology device (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

Submission Details

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.

Device Classification

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 34
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
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
PASCO MIC AND MIC/ID PANELS
K001721 · Pasco Laboratories, Inc. · Aug 2000