Cleared Traditional

K863603 - GI MOTILITY TEST MEDIUM W/TTC

K863603 is the FDA 510(k) clearance for GI MOTILITY TEST MEDIUM W/TTC by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 1 Microbiology device (product code JSS) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K863603 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Sep 1986
Decision
15d
Days
Class 1
Risk

K863603 is an FDA 510(k) clearance for the GI MOTILITY TEST MEDIUM W/TTC. Classified as Kit, Identification, Enterobacteriaceae (product code JSS), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on September 30, 1986 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 K863603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1986
Decision Date September 30, 1986
Days to Decision 15 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
87d faster than avg
Panel avg: 102d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSS Kit, Identification, Enterobacteriaceae
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - JSS Kit, Identification, Enterobacteriaceae

All 23
Devices cleared under the same product code (JSS) and FDA review panel - the closest regulatory comparables to K863603.
ROCHE ENTEROTUBE II
K922588 · Roche Diagnostic Systems, Inc. · Sep 1992
SENSITITRE INDOLE REAGENT
K894776 · Radiometer America, Inc. · Aug 1989
VITEK GRAM-NEGATIVE IDENTIFICATION CARD
K883558 · Vitek Systems, Inc. · Sep 1988
COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT
K853009 · Roche Diagnostic Systems, Inc. · Mar 1986
RIM-UREA
K843571 · Austin Biological Laboratories · Oct 1984
TITERTEK ENTEROBAC*
K834090 · Flow Laboratories, Inc. · Jan 1984