Cleared Traditional

K062681 - SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PN...

K062681 is the FDA 510(k) clearance for SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PN... by Trek Diagnostic Systems, Ltd.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K062681 · Trek Diagnostic Systems, Ltd. · Microbiology device
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Oct 2006
Decision
35d
Days
Class 2
Risk

K062681 is an FDA 510(k) clearance for the SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Trek Diagnostic Systems, Ltd. (Cleveland, US). The FDA issued a Cleared decision on October 13, 2006 after a review of 35 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, Ltd. devices

Submission Details

510(k) Number K062681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2006
Decision Date October 13, 2006
Days to Decision 35 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 102d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
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 - JWY Manual Antimicrobial Susceptibility Test Systems

All 361
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K062681.
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062816 · Trek Diagnostic Systems, Inc. · Nov 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062783 · Trek Diagnostic Systems, Inc. · Oct 2006
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062722 · Trek Diagnostic Systems, Inc. · Oct 2006
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE
K062022 · Trek Diagnostic Systems, Inc. · Sep 2006
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATES
K062190 · Trek Diagnostic Systems, Inc. · Aug 2006
MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS
K061687 · Dade Behring, Inc. · Jul 2006