Cleared Traditional

K121455 - BACT/ALERT FN PLUS CULTURE BOTTLE

K121455 is the FDA 510(k) clearance for BACT/ALERT FN PLUS CULTURE BOTTLE by bioMerieux, Inc.. It is a Class 1 Microbiology device (product code MDB) cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K121455 · bioMerieux, Inc. · Microbiology device
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Jan 2013
Decision
254d
Days
Class 1
Risk

K121455 is an FDA 510(k) clearance for the BACT/ALERT FN PLUS CULTURE BOTTLE. Classified as System, Blood Culturing (product code MDB), Class I - General Controls.

Submitted by bioMerieux, Inc. (Durham, US). The FDA issued a Cleared decision on January 25, 2013 after a review of 254 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 bioMerieux, Inc. devices

Submission Details

510(k) Number K121455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2012
Decision Date January 25, 2013
Days to Decision 254 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
152d slower than avg
Panel avg: 102d · This submission: 254d
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 52
Devices cleared under the same product code (MDB) and FDA review panel - the closest regulatory comparables to K121455.
BD BACTEC PLUS ANAEROBIC/F (PLASTIC)
K141810 · Becton, Dickinson and Company · Dec 2014
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K123903 · Becton, Dickinson & CO · May 2013
BACT/ALERT PF PLUS CULTURE BOTTLE
K121446 · bioMerieux, Inc. · Jan 2013
BACT/ALERT FA PLUS CULTURE BOTTLE
K121461 · bioMerieux, Inc. · Jan 2013
BD BACTEC Plus PRIME Aerobic/F Culture Vials
K120994 · Becton, Dickinson and Company · Aug 2012
BD BACTEC Plus Aerobic/F Culture Vials (plastic)
K113558 · Becton, Dickinson and Company · Mar 2012