Cleared Traditional

K020815 - BACT/ALERT FN CULTURE BOTTLE

K020815 is the FDA 510(k) clearance for BACT/ALERT FN CULTURE BOTTLE by bioMerieux, Inc.. It is a Class 1 Microbiology device (product code MDB) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K020815 · bioMerieux, Inc. · Microbiology device
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Apr 2002
Decision
36d
Days
Class 1
Risk

K020815 is an FDA 510(k) clearance for the BACT/ALERT FN 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 April 18, 2002 after a review of 36 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 bioMerieux, Inc. devices

Submission Details

510(k) Number K020815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2002
Decision Date April 18, 2002
Days to Decision 36 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
66d faster than avg
Panel avg: 102d · This submission: 36d
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 53
Devices cleared under the same product code (MDB) and FDA review panel - the closest regulatory comparables to K020815.
VERSATREK
K032306 · Trek Diagnostic Systems, Inc. · Aug 2003
BACT/ALERT MP CULTURE BOTTLES (PLASTIC)
K031737 · bioMerieux, Inc. · Jul 2003
BACT/ALERT SN CULTURE BOTTLE
K021123 · bioMerieux, Inc. · Apr 2002
BACT/ALERT PF CULTURE BOTTLE
K020923 · bioMerieux, Inc. · Apr 2002
BACT/ALERT SA CULTURE BOTTLE
K020931 · bioMerieux, Inc. · Apr 2002
BACT/ALERT FA CULTURE BOTTLE
K020813 · bioMerieux, Inc. · Apr 2002