Cleared Traditional

K093741 - SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIBILITY PLATES

K093741 is an FDA 510(k) clearance for SENSITIVE HAEMOPHILUS INFLUENZAE, manufactured by Trek Diagnostic Systems, Ltd.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K093741 · Trek Diagnostic Systems, Ltd. · Microbiology device
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Feb 2010
Decision
83d
Days
Class 2
Risk

K093741 is an FDA 510(k) clearance for the SENSITIVE HAEMOPHILUS INFLUENZAE, STREPTOCOCCUS PNEUMONIA, (HP) MIC SUSCEPTIB.... 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 February 25, 2010 after a review of 83 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

FDA 510(k) Submission Details - K093741

510(k) Number K093741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2009
Decision Date February 25, 2010
Days to Decision 83 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
19d faster than avg
Panel avg: 102d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWY Device Classification - Class 2, Special Controls

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 405
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K093741.
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