Cleared Traditional

K896859 - ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TEST (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K896859 · Gen-Probe, Inc. · Microbiology device
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Feb 1990
Decision
58d
Days
Class 2
Risk

K896859 is an FDA 510(k) clearance for the ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TEST. Classified as Dna-probe, Reagent, Histoplasma Capsulatum (product code MBT), Class II - Special Controls.

Submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on February 1, 1990 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3320 - 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 K896859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1989
Decision Date February 01, 1990
Days to Decision 58 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 102d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MBT Dna-probe, Reagent, Histoplasma Capsulatum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3320
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.