Cleared Traditional

K103532 - AUTOREADER 2

K103532 is the FDA 510(k) clearance for AUTOREADER 2 by Trek Diagnostic Systems. It is a Class 2 Microbiology device (product code LRG) cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K103532 · Trek Diagnostic Systems · Microbiology device
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Aug 2011
Decision
268d
Days
Class 2
Risk

K103532 is an FDA 510(k) clearance for the AUTOREADER 2. Classified as Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (product code LRG), Class II - Special Controls.

Submitted by Trek Diagnostic Systems (Cleveland, US). The FDA issued a Cleared decision on August 26, 2011 after a review of 268 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

Submission Details

510(k) Number K103532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2010
Decision Date August 26, 2011
Days to Decision 268 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
166d slower than avg
Panel avg: 102d · This submission: 268d
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 38
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