Cleared Traditional

K052485 - SHERLOCK MICROBIAL IDENTIFICATION SYSTEM FOR BIODEF

K052485 is an FDA 510(k) clearance for SHERLOCK MICROBIAL IDENTIFICATION SYSTE..., manufactured by Midi, Inc.. The device is a Class 2 Microbiology device with product code NWZ cleared through the Traditional 510(k) pathway after a 130-day FDA review.

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

FDA 510(k) Submission Details - K052485

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.

NWZ Device Classification - Class 2, Special Controls

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.