Cleared Traditional

BACT/ALERT 120 (K934593) - FDA 510(k) Clearance

Class I Microbiology device.

K934593 · Organon Teknika Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
138d
Days
Class 1
Risk

K934593 is an FDA 510(k) clearance for the BACT/ALERT 120. 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 February 9, 1994 after a review of 138 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K934593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1993
Decision Date February 09, 1994
Days to Decision 138 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
36d slower than avg
Panel avg: 102d · This submission: 138d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 47
Devices cleared under the same product code (MDB) and FDA review panel - the closest regulatory comparables to K934593.
MB/BACT MYCROBACTERIA DETECTION SYSTEM
K954468 · Organon Teknika Corp. · Jul 1996
BACT/ALERT FAN CULTURE BOTTLE
K944594 · Organon Teknika Corp. · Feb 1995
BACT/ALERT FAN AEROBIC CULTURE BOTTLE
K935711 · Organon Teknika Corp. · Aug 1994
BACTEC PEDS PLUS/F
K926304 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1993
BACTEC 9120 SYSTEM
K922475 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1992
BACT/ALERT PEDI-BACT
K920249 · Organon Teknika Corp. · Apr 1992