Cleared Traditional

K013195 - HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (H...

K013195 is the FDA 510(k) clearance for HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (H... by Trek Diagnostic Systems, Inc.. It is a Class 2 Microbiology device (product code LTT) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K013195 · Trek Diagnostic Systems, Inc. · Microbiology device
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Nov 2001
Decision
43d
Days
Class 2
Risk

K013195 is an FDA 510(k) clearance for the HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES. Classified as Panels, Test, Susceptibility, Antimicrobial (product code LTT), Class II - Special Controls.

Submitted by Trek Diagnostic Systems, Inc. (Westlake, US). The FDA issued a Cleared decision on November 7, 2001 after a review of 43 days - a notably fast clearance 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: 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 Trek Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K013195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2001
Decision Date November 07, 2001
Days to Decision 43 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 102d · This submission: 43d
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 44
Devices cleared under the same product code (LTT) and FDA review panel - the closest regulatory comparables to K013195.
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN
K020626 · Dade Microscan, Inc. · Apr 2002
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
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K010418 · Dade Behring, Inc. · Aug 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