Cleared Traditional

K993186 - SYNERCID

K993186 is the FDA 510(k) clearance for SYNERCID by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K993186 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
42d
Days
Class 2
Risk

K993186 is an FDA 510(k) clearance for the SYNERCID, 15 UG, BBL SENSI-DISC. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sparks, US). The FDA issued a Cleared decision on November 3, 1999 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1620 - 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 K993186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1999
Decision Date November 03, 1999
Days to Decision 42 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 102d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JTN Susceptibility Test Discs, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JTN Susceptibility Test Discs, Antimicrobial

All 294
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K993186.
CEFOTAXIME/CLAVULANIC, 30/10UG, BBL SENSI-DISC AND CEFTAZIDIME/CLAVULANIC ACID, 30/10UG, BBL SENSI-DISC
K993577 · Becton Dickinson Microbiology Systems · Dec 1999
PASCO MIC AND MIC/ID PANELS, CEFDINIR
K992853 · Pasco Laboratories, Inc. · Nov 1999
PASCO MIC AND MIC/ID PANELS, QUINUPRISTIN/DALFOPRISTIN FOR NONFASTIDIOUS ORGANISMS
K992726 · Pasco Laboratories, Inc. · Nov 1999
PASCO MIC AND MIC/ID PANELS,QUINUPRISTIN/DALFOPRISTIN
K992717 · Pasco Laboratories, Inc. · Nov 1999
PASCO MIC AND MIC/ID PANELS, PENICILLIN
K992646 · Pasco Laboratories, Inc. · Oct 1999
PASCO MIC AND MIC/ID PANELS, ERYTHROMYCIN
K992647 · Pasco Laboratories, Inc. · Oct 1999