Cleared Traditional

K872938 - AMPICIILLIN SULBACTAM 20MCG SENSITIVITY...

K872938 is the FDA 510(k) clearance for AMPICIILLIN SULBACTAM 20MCG SENSITIVITY... by Difco Laboratories, Inc.. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K872938 · Difco Laboratories, Inc. · Microbiology device
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Aug 1987
Decision
10d
Days
Class 2
Risk

K872938 is an FDA 510(k) clearance for the AMPICIILLIN SULBACTAM 20MCG SENSITIVITY DISKS. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on August 6, 1987 after a review of 10 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 K872938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1987
Decision Date August 06, 1987
Days to Decision 10 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
92d faster than avg
Panel avg: 102d · This submission: 10d
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 K872938.
CIPROFLOXACIN 5 MCG SENSI-DISC
K874425 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1987
CIPROFLOXACIN 5 MCG SUSCEPTIBILITY DISK
K873707 · Organon Teknika Corp. · Oct 1987
CIPRO SENSITIVITY DISKS
K873829 · Difco Laboratories, Inc. · Oct 1987
AMPICILLIN/SULBACTAM 20 MCG SENSI-DISC
K872783 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1987
TICARCILLIN/CLVULINIC ACID 85 MCG SUSCEPTIBILITY D
K871674 · Organon Teknika Corp. · May 1987
BROTH ELUTION DISKS CLINDAMYCIN 10MCG
K870175 · Difco Laboratories, Inc. · Apr 1987