Cleared Traditional

SENSITITRE ARIS MODULE (K911419) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K911419 · Sensititre , Ltd. · Microbiology device
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Jul 1992
Decision
457d
Days
Class 2
Risk

K911419 is an FDA 510(k) clearance for the SENSITITRE ARIS MODULE. Classified as Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (product code LRG), Class II - Special Controls.

Submitted by Sensititre , Ltd. (Westlake, US). The FDA issued a Cleared decision on July 1, 1992 after a review of 457 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Sensititre , Ltd. devices

Submission Details

510(k) Number K911419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1991
Decision Date July 01, 1992
Days to Decision 457 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
355d slower than avg
Panel avg: 102d · This submission: 457d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. 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 - LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

All 44
Devices cleared under the same product code (LRG) and FDA review panel - the closest regulatory comparables to K911419.
Thermo Scientific Sensititre ARIS HiQ System
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Thermo Scientific Sensititre ARIS HiQ System
K191918 · Thermo Fisher Scientific · Nov 2019
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K063099 · Dade Behring, Inc. · Nov 2006