Cleared Traditional

K000884 - BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY (FDA 510(k) Clearance)

Class I Microbiology device.

K000884 · Becton Dickinson Biosciences · Microbiology device
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Jan 2001
Decision
305d
Days
Class 1
Risk

K000884 is an FDA 510(k) clearance for the BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATIO.... Classified as Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis (product code NDZ), Class I - General Controls.

Submitted by Becton Dickinson Biosciences (Sparks, US). The FDA issued a Cleared decision on January 19, 2001 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K000884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2000
Decision Date January 19, 2001
Days to Decision 305 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
203d slower than avg
Panel avg: 102d · This submission: 305d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NDZ Assay, Nucleic Acid Amplification, Growth Identification, Mycobacterium Tuberculosis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3370
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.