Cleared Traditional

K161306 - BD BACTEC Standard Anaerobic/F Culture ...

K161306 is an FDA 510(k) clearance for BD BACTEC Standard Anaerobic/F Culture ..., manufactured by Becton Dickinson. The device is a Class 1 Microbiology device with product code MDB cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K161306 · Becton Dickinson · Microbiology device
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Aug 2016
Decision
90d
Days
Class 1
Risk

K161306 is an FDA 510(k) clearance for the BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a.... Classified as System, Blood Culturing (product code MDB), Class I - General Controls.

Submitted by Becton Dickinson (Sparks, US). The FDA issued a Cleared decision on August 8, 2016 after a review of 90 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.

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FDA 510(k) Submission Details - K161306

510(k) Number K161306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2016
Decision Date August 08, 2016
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
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 57
Devices cleared under the same product code (MDB) and FDA review panel - the closest regulatory comparables to K161306.
BacT/ALERT FA Plus
K183166 · bioMerieux, Inc. · Feb 2019
BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial
K173873 · Becton, Dickinson and Company · Mar 2018
BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO
K161816 · bioMerieux, Inc. · Mar 2017
BD BACTEC Peds Plus/F Culture Vials (plastic)
K151866 · Becton, Dickinson and Company · Feb 2016
BD BACTEC PLUS ANAEROBIC/F (PLASTIC)
K141810 · Becton, Dickinson and Company · Dec 2014
BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic)
K123903 · Becton, Dickinson & CO · May 2013