Cleared Traditional

K954468 - MB/BACT MYCROBACTERIA DETECTION SYSTEM

K954468 is an FDA 510(k) clearance for MB/BACT MYCROBACTERIA DETECTION SYSTEM, manufactured by Organon Teknika Corp.. The device is a Class 1 Microbiology device with product code MDB cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K954468 · Organon Teknika Corp. · Microbiology device
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Optimized for regulatory review, auditing and printing
Jul 1996
Decision
300d
Days
Class 1
Risk

K954468 is an FDA 510(k) clearance for the MB/BACT MYCROBACTERIA DETECTION SYSTEM. Classified as System, Blood Culturing (product code MDB), Class I - General Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on July 22, 1996 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2560 - 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K954468

510(k) Number K954468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1995
Decision Date July 22, 1996
Days to Decision 300 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
198d slower than avg
Panel avg: 102d · This submission: 300d
Pathway characteristics
Predicate-based equivalence.

MDB Device Classification - Class 1, General Controls

Product Code MDB System, Blood Culturing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2560
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 - MDB System, Blood Culturing

All 56
Devices cleared under the same product code (MDB) and FDA review panel - the closest regulatory comparables to K954468.
BACT/ALERT FAN CULTURE BOTTLES
K973325 · Organon Teknika Corp. · Dec 1997
BACT/ALERT CULTURE BOTTLES
K973305 · Organon Teknika Corp. · Nov 1997
BACTEC MYCO/F-SPUTA CULTURE VIALS
K972758 · Becton Dickinson Microbiology Systems · Aug 1997
ESP CULTURE SYSTEM - MYCO
K953129 · Difco Laboratories, Inc. · Dec 1995
BACT/ALERT FAN CULTURE BOTTLE
K944594 · Organon Teknika Corp. · Feb 1995
BACT/ALERT FAN AEROBIC CULTURE BOTTLE
K935711 · Organon Teknika Corp. · Aug 1994