Cleared Traditional

K052485 - SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF (FDA 510(k) Clearance)

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

K052485 · Midi, Inc. · Microbiology device
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Jan 2006
Decision
130d
Days
Class 2
Risk

K052485 is an FDA 510(k) clearance for the SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF. Classified as Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids (product code NWZ), Class II - Special Controls.

Submitted by Midi, Inc. (Newark, US). The FDA issued a Cleared decision on January 17, 2006 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3045 - 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 Midi, Inc. devices

Submission Details

510(k) Number K052485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2005
Decision Date January 17, 2006
Days to Decision 130 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 102d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NWZ Gas Chromatography, Bacillus Anthracis Membrane Fatty Acids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3045
Definition Aid In The Identification Of Bacillus Anthracis
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.