Cleared Traditional

BACTEC MYCO/F LYTIC CULTURE VIALS (K970512) - FDA 510(k) Clearance

Class I Microbiology device.

K970512 · Becton Dickinson Microbiology Systems · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
331d
Days
Class 1
Risk

K970512 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 8, 1998 after a review of 331 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

Submission Details

510(k) Number K970512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1997
Decision Date January 08, 1998
Days to Decision 331 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
229d slower than avg
Panel avg: 102d · This submission: 331d
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 67
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