Cleared Traditional

K830363 - BACTEC 170 TRYPTIC SOY BROTH W/RESINS (FDA 510(k) Clearance)

Class I Microbiology device.

K830363 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Mar 1983
Decision
48d
Days
Class 1
Risk

K830363 is an FDA 510(k) clearance for the BACTEC 170 TRYPTIC SOY BROTH W/RESINS. Classified as Device, Antimicrobial Drug Removal (product code LJF), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 48 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K830363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1983
Decision Date March 24, 1983
Days to Decision 48 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 102d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJF Device, Antimicrobial Drug Removal
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.