Cleared Traditional

K110331 - SENSITITRE AIM (TM)

K110331 is an FDA 510(k) clearance for SENSITITRE AIM (TM), manufactured by Trek Diagnostic Systems, Ltd.. The device is a Class 2 Microbiology device with product code LIE cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K110331 · Trek Diagnostic Systems, Ltd. · Microbiology device
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Apr 2011
Decision
83d
Days
Class 2
Risk

K110331 is an FDA 510(k) clearance for the SENSITITRE AIM (TM). Classified as Reagent/device, Inoculum Calibration (product code LIE), Class II - Special Controls.

Submitted by Trek Diagnostic Systems, Ltd. (Cleveland, US). The FDA issued a Cleared decision on April 27, 2011 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 - K110331

510(k) Number K110331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2011
Decision Date April 27, 2011
Days to Decision 83 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
19d faster than avg
Panel avg: 102d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIE Device Classification - Class 2, Special Controls

Product Code LIE Reagent/device, Inoculum Calibration
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 - LIE Reagent/device, Inoculum Calibration

Devices cleared under the same product code (LIE) and FDA review panel - the closest regulatory comparables to K110331.
MicroScan Prompt Inoculation System-D
K221493 · Beckman Coulter, Inc. · Apr 2023
THE SENSITITRE AIM
K103456 · Trek Diagnostic Systems · Jun 2011
SENSI-CAL AMCO AEPA-1
K935566 · Radiometer America, Inc. · Mar 1994
TURBIDOMETRIC STANDARD
K911059 · Scientific Device Laboratory, Inc. · Jun 1991
DIFCO DIRECTOR INOCULATION SYSTEM
K890339 · Difco Laboratories, Inc. · Feb 1989
PROMPT INOCULATION SYSTEM
K820299 · 3M Company · Mar 1982