Cleared Traditional

K901397 - ACCUPROBE LISTERIA MONOCYTOGENES CULTUR...

K901397 is an FDA 510(k) clearance for ACCUPROBE LISTERIA MONOCYTOGENES CULTUR..., manufactured by Gen-Probe, Inc.. The device is a Class 2 Microbiology device with product code MCC cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K901397 · Gen-Probe, Inc. · Microbiology device
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Jun 1990
Decision
86d
Days
Class 2
Risk

K901397 is an FDA 510(k) clearance for the ACCUPROBE LISTERIA MONOCYTOGENES CULTURE CONFIRMA.. Classified as Dna-probe, Haemophilus Spp. (product code MCC), Class II - Special Controls.

Submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on June 20, 1990 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3300 - 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

FDA 510(k) Submission Details - K901397

510(k) Number K901397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1990
Decision Date June 20, 1990
Days to Decision 86 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 102d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MCC Device Classification - Class 2, Special Controls

Product Code MCC Dna-probe, Haemophilus Spp.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3300
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.