Cleared Traditional

TOC (TWEEN 80 - OXGALL-CAFFEIC ACID) AGAR (K863523) - FDA 510(k) Clearance

Class I Microbiology device.

K863523 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Sep 1986
Decision
9d
Days
Class 1
Risk

K863523 is an FDA 510(k) clearance for the TOC (TWEEN 80 - OXGALL-CAFFEIC ACID) AGAR. Classified as Culture Media, Non-selective And Differential (product code JSH), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on September 19, 1986 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2320 - 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 K863523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1986
Decision Date September 19, 1986
Days to Decision 9 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
93d faster than avg
Panel avg: 102d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSH Culture Media, Non-selective And Differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2320
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 - JSH Culture Media, Non-selective And Differential

All 42
Devices cleared under the same product code (JSH) and FDA review panel - the closest regulatory comparables to K863523.
BIRD SEED AGAR
K863573 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
STARCH AGAR W/BROM CRESOL PURPLE
K863599 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
MOTILITY INDOLE LYSINE SULFIDE (MILS) MEDIUM
K863600 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1986
UREA AGAR
K844548 · bioMerieux, Inc. · Jan 1985
V AGAR
K844513 · bioMerieux, Inc. · Jan 1985
DTM AGAR
K844514 · bioMerieux, Inc. · Jan 1985