Cleared Traditional

CLOSTRIDIUM DIFFICILE (K833136) - FDA 510(k) Clearance

Class I Microbiology device.

K833136 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Oct 1983
Decision
43d
Days
Class 1
Risk

K833136 is an FDA 510(k) clearance for the CLOSTRIDIUM DIFFICILE. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on October 27, 1983 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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 K833136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1983
Decision Date October 27, 1983
Days to Decision 43 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 102d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSJ Culture Media, Selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSJ Culture Media, Selective And Non-differential

All 64
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K833136.
TRICHOMONAS BROTH
K844533 · bioMerieux, Inc. · Jan 1985
CAMPYLOBACTER CVA AGAR
K844534 · bioMerieux, Inc. · Jan 1985
CIN AGAR YERSINIA-SELECTIVE AGAR
K833010 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1983
LOWENSTEIN-JENSEN MEDIUM BASE
K833220 · Acumedia Manufacturers, Inc. · Oct 1983
BILE ESCULIN AZIDE AGAR
K830080 · bioMerieux, Inc. · Feb 1983
SABOURAND DEXTROSE AGAR
K830066 · bioMerieux, Inc. · Feb 1983