Cleared Traditional

K020689 - SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM (FDA 510(k) Clearance)

Class I Microbiology device.

K020689 · Midi, Inc. · Microbiology device
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Oct 2002
Decision
241d
Days
Class 1
Risk

K020689 is an FDA 510(k) clearance for the SHERLOCK MYCOBACTERIA IDENTIFICATION SYSTEM. Classified as System, Mycolic Acid Analysis, Mycobacterium Tuberculosis (product code NJO), Class I - General Controls.

Submitted by Midi, Inc. (Newark, US). The FDA issued a Cleared decision on October 31, 2002 after a review of 241 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3370 - 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.

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Submission Details

510(k) Number K020689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2002
Decision Date October 31, 2002
Days to Decision 241 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
139d slower than avg
Panel avg: 102d · This submission: 241d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NJO System, Mycolic Acid Analysis, Mycobacterium Tuberculosis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3370
Definition A Mycolic Acids Analysis System Is Intended To Aid In The Identification Of M. Tuberculosis And Differentiation From Other Mycobacteria Species Through The Analysis Of Mycolic Acids Derived From Cultured Bacterial Samples, Using High Performance Liquid Chromatography (hplc) Performed And Pattern Recognition Software. The System Is Used, Along With Other Identification Methods, To Identify Mycobacteria That Have Been Isolated From Clinical Specimens By Traditional Culturing Techniques. Following Observation Of Growth On The Solid Medium, Identification Of The Mycobacterial Isolate Is Done With Extraction And Analysis Of Mycolic Acids. Results Should Be Interpreted In Conjunction With Other Laboratory Observations And Procedures.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.