Cleared Traditional

K801474 - TRIMETHOPRIM 5MCG. SENSITIVITY DISCS

K801474 is the FDA 510(k) clearance for TRIMETHOPRIM 5MCG. SENSITIVITY DISCS by Difco Laboratories, Inc.. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K801474 · Difco Laboratories, Inc. · Microbiology device
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Aug 1980
Decision
50d
Days
Class 2
Risk

K801474 is an FDA 510(k) clearance for the TRIMETHOPRIM 5MCG. SENSITIVITY DISCS. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Difco Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 13, 1980 after a review of 50 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 Difco Laboratories, Inc. devices

Submission Details

510(k) Number K801474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1980
Decision Date August 13, 1980
Days to Decision 50 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
52d faster than avg
Panel avg: 102d · This submission: 50d
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 282
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K801474.
CEFOTAXIME 30 MCG. SENSI-DISC.
K810564 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1981
MINOCYCLINE 30MCG. SENSI DISC
K802194 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1980
MINOCYCLINE 30 MCG. SENSITIVITY DISCS
K802178 · Difco Laboratories, Inc. · Oct 1980
TRIMETHROPRIM 5MCG. SENSI DISC.
K801648 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1980
CINOXACIN 100 MCG. SENSITIVITY DISCS
K801473 · Difco Laboratories, Inc. · Jul 1980
CINOXACIN 100 MCG SENSI DISC
K800540 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1980