Cleared Traditional

K862614 - RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX (FDA 510(k) Clearance)

Class I Microbiology device.

K862614 · Gen-Probe, Inc. · Microbiology device
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Nov 1986
Decision
124d
Days
Class 1
Risk

K862614 is an FDA 510(k) clearance for the RAPID IDENTI. TEST FOR MYCOBACTERIUM TB COMPLEX. Classified as Dna-reagents, Mycobacterium Spp. (product code LQF), Class I - General Controls.

Submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on November 10, 1986 after a review of 124 days - within the typical 510(k) review window.

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.

View all Gen-Probe, Inc. devices

Submission Details

510(k) Number K862614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1986
Decision Date November 10, 1986
Days to Decision 124 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 102d · This submission: 124d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQF Dna-reagents, Mycobacterium Spp.
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.