Cleared Traditional

K103456 - THE SENSITITRE AIM

K103456 is an FDA 510(k) clearance for THE SENSITITRE AIM, manufactured by Trek Diagnostic Systems. The device is a Class 2 Microbiology device with product code LIE cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K103456 · Trek Diagnostic Systems · Microbiology device
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Jun 2011
Decision
210d
Days
Class 2
Risk

K103456 is an FDA 510(k) clearance for the THE SENSITITRE AIM. Classified as Reagent/device, Inoculum Calibration (product code LIE), Class II - Special Controls.

Submitted by Trek Diagnostic Systems (Cleveland, US). The FDA issued a Cleared decision on June 22, 2011 after a review of 210 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 Trek Diagnostic Systems devices

FDA 510(k) Submission Details - K103456

510(k) Number K103456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2010
Decision Date June 22, 2011
Days to Decision 210 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
108d slower than avg
Panel avg: 102d · This submission: 210d
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 K103456.
MicroScan Prompt Inoculation System-D
K221493 · Beckman Coulter, Inc. · Apr 2023
SENSITITRE AIM (TM)
K110331 · Trek Diagnostic Systems, Ltd. · Apr 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