Cleared Traditional

K163436 - Greiner Vacuette Urine Count and Culture

K163436 is the FDA 510(k) clearance for Greiner Vacuette Urine Count and Culture by Greiner Bio-One Na, Inc.. It is a Class 1 Microbiology device (product code JSM) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K163436 · Greiner Bio-One Na, Inc. · Microbiology device
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Mar 2017
Decision
89d
Days
Class 1
Risk

K163436 is an FDA 510(k) clearance for the Greiner Vacuette Urine Count and Culture, Mannitol tube. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Greiner Bio-One Na, Inc. (Monroe, US). The FDA issued a Cleared decision on March 6, 2017 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - 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 Greiner Bio-One Na, Inc. devices

Submission Details

510(k) Number K163436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2016
Decision Date March 06, 2017
Days to Decision 89 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
13d faster than avg
Panel avg: 102d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSM Culture Media, Non-propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
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.

Regulatory Peers - JSM Culture Media, Non-propagating Transport

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A.C.T. I
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