Cleared Traditional

K970333 - BACTEC MYCO/F LYTIC CULTURE VIALS

K970333 is an FDA 510(k) clearance for BACTEC MYCO/F LYTIC CULTURE VIALS, manufactured by Becton Dickinson Microbiology Systems. The device is a Class 1 Microbiology device with product code MDB cleared through the Traditional 510(k) pathway after a 365-day FDA review.

K970333 · Becton Dickinson Microbiology Systems · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
365d
Days
Class 1
Risk

K970333 is an FDA 510(k) clearance for the BACTEC MYCO/F LYTIC CULTURE VIALS. Classified as System, Blood Culturing (product code MDB), Class I - General Controls.

Submitted by Becton Dickinson Microbiology Systems (Sparks, US). The FDA issued a Cleared decision on January 28, 1998 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Becton Dickinson Microbiology Systems devices

FDA 510(k) Submission Details - K970333

510(k) Number K970333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1997
Decision Date January 28, 1998
Days to Decision 365 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
263d slower than avg
Panel avg: 102d · This submission: 365d
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 67
Devices cleared under the same product code (MDB) and FDA review panel - the closest regulatory comparables to K970333.
MB/BACT BLOOD CULTURE BOTTLE
K982263 · Organon Teknika Corp. · Aug 1998
BACT/ALERT 3D MICROBIAL DETECTION SYSTEM
K981736 · Organon Teknika Corp. · Jul 1998
BACTEC MGIT 960 SYSTEM
K974883 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1998
BACTEC MYCO/F LYTIC CULTURE VIALS
K970512 · Becton Dickinson Microbiology Systems · Jan 1998
BACT/ALERT FAN CULTURE BOTTLES
K973325 · Organon Teknika Corp. · Dec 1997
BACT/ALERT CULTURE BOTTLES
K973305 · Organon Teknika Corp. · Nov 1997