Cleared Traditional

K871795 - RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER. (FDA 510(k) Clearance)

Class I Microbiology device.

K871795 · Gen-Probe, Inc. · Microbiology device
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Jul 1987
Decision
84d
Days
Class 1
Risk

K871795 is an FDA 510(k) clearance for the RAPID DIAGNOSTIC SYSTEM FOR MYCOBACTERIUM TUBER.. 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 July 30, 1987 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gen-Probe, Inc. devices

Submission Details

510(k) Number K871795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1987
Decision Date July 30, 1987
Days to Decision 84 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 102d · This submission: 84d
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.