Cleared Traditional

K895679 - CEFMATZOLE 30 MCG SENSI DISC

K895679 is the FDA 510(k) clearance for CEFMATZOLE 30 MCG SENSI DISC 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 104-day FDA review.

K895679 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Jan 1990
Decision
104d
Days
Class 2
Risk

K895679 is an FDA 510(k) clearance for the CEFMATZOLE 30 MCG SENSI DISC. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on January 2, 1990 after a review of 104 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K895679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1989
Decision Date January 02, 1990
Days to Decision 104 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
2d slower than avg
Panel avg: 102d · This submission: 104d
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 K895679.
FLOXIN SUSCEPTIBILITY TEST DISKS
K910412 · Difco Laboratories, Inc. · Feb 1991
ZEFAZONE SUSCEPTIBILITY TEST DISKS
K902082 · Difco Laboratories, Inc. · Jun 1990
CEFIXIME 5 MCG SUSCEPTIBILITY DISK
K900344 · Organon Teknika Corp. · Feb 1990
ANTIMICROBIAL SUSCEPTIBILITY DISK
K895392 · Organon Teknika Corp. · Oct 1989
CEFIXIME 5 MCG SENSITIVITY DISKS
K894829 · Difco Laboratories, Inc. · Sep 1989
SPECTINOMYCIN 100 MCG SENSI-DISC
K891772 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1989