Cleared Traditional

BACT/ALERT SN (K993421) - FDA 510(k) Clearance

Class I Microbiology device.

K993421 · Organon Teknika Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
63d
Days
Class 1
Risk

K993421 is an FDA 510(k) clearance for the BACT/ALERT SN. 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 December 14, 1999 after a review of 63 days - a notably fast clearance 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: 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 Organon Teknika Corp. devices

Submission Details

510(k) Number K993421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1999
Decision Date December 14, 1999
Days to Decision 63 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
39d faster than avg
Panel avg: 102d · This submission: 63d
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 K993421.
BACT/ALERT MB CULTURE BOTTLE
K000378 · Organon Teknika Corp. · Mar 2000
BACT/ALERT SV
K994343 · Organon Teknika Corp. · Feb 2000
BACT/ALERT SA
K993423 · Organon Teknika Corp. · Dec 1999
BACT/ALERT MP PROCESS BOTTLE
K993576 · Organon Teknika Corp. · Dec 1999
BACT/ALERT FN
K992432 · Organon Teknika Corp. · Sep 1999
BACTALERT FA
K992400 · Organon Teknika Corp. · Sep 1999