Cleared Traditional

K903505 - BACT/ALERT (TM)

K903505 is an FDA 510(k) clearance for BACT/ALERT (TM), 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 221-day FDA review.

K903505 · Organon Teknika Corp. · Microbiology device
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Mar 1991
Decision
221d
Days
Class 1
Risk

K903505 is an FDA 510(k) clearance for the BACT/ALERT (TM). 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 March 12, 1991 after a review of 221 days - an extended review cycle.

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 - K903505

510(k) Number K903505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1990
Decision Date March 12, 1991
Days to Decision 221 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
119d slower than avg
Panel avg: 102d · This submission: 221d
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 K903505.
BACTEC 9240 SYSTEM
K915796 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA
K921133 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
BACTEC FOS CULTURE SUPPLEMENT
K920933 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
PENASE
K833888 · Oxoid U.S.A., Inc. · Jan 1984
BACTEC RESIN CULTURE MED. 16A
K812315 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1981
ANTIMICROBIAL REMOVAL DEVICE
K810613 · Marion Laboratories, Inc. · Apr 1981