Cleared Traditional

K894829 - CEFIXIME 5 MCG SENSITIVITY DISKS

K894829 is an FDA 510(k) clearance for CEFIXIME 5 MCG SENSITIVITY DISKS, manufactured by Difco Laboratories, Inc.. The device is a Class 2 Microbiology device with product code JTN cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K894829 · Difco Laboratories, Inc. · Microbiology device
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Sep 1989
Decision
39d
Days
Class 2
Risk

K894829 is an FDA 510(k) clearance for the CEFIXIME 5 MCG 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 September 8, 1989 after a review of 39 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

FDA 510(k) Submission Details - K894829

510(k) Number K894829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1989
Decision Date September 08, 1989
Days to Decision 39 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
63d faster than avg
Panel avg: 102d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JTN Device Classification - Class 2, Special Controls

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 323
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K894829.
IFA SENSIBAC CEFACLOR
K892721 · Investigacion Farmaceutica S.A. DE C.V. · Nov 1989
ANTIMICROBIAL SUSCEPTIBILITY DISK
K895392 · Organon Teknika Corp. · Oct 1989
IFA SENSIBAC NORFLOXACIN
K892728 · Investigacion Farmaceutica S.A. DE C.V. · Sep 1989
SPECTINOMYCIN 100 MCG SENSI-DISC
K891772 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1989
IFA SENSIBAC NALIDIXIC ACID
K892713 · Investigacion Farmaceutica S.A. DE C.V. · Aug 1989
IFA SENSIBAC KANAMYCIN
K892733 · Investigacion Farmaceutica S.A. DE C.V. · Aug 1989