Cleared Traditional

K881579 - AMIES TRANSPORT MEDIUM W/O CHARCOAL

K881579 is the FDA 510(k) clearance for AMIES TRANSPORT MEDIUM W/O CHARCOAL by Acumedia Manufacturers, Inc.. It is a Class 1 Microbiology device (product code JSN) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K881579 · Acumedia Manufacturers, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1988
Decision
7d
Days
Class 1
Risk

K881579 is an FDA 510(k) clearance for the AMIES TRANSPORT MEDIUM W/O CHARCOAL. Classified as Culture Media, Propagating Transport (product code JSN), Class I - General Controls.

Submitted by Acumedia Manufacturers, Inc. (Baltimore, US). The FDA issued a Cleared decision on April 18, 1988 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - 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 Acumedia Manufacturers, Inc. devices

Submission Details

510(k) Number K881579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1988
Decision Date April 18, 1988
Days to Decision 7 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
95d faster than avg
Panel avg: 102d · This submission: 7d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSN Culture Media, Propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JSN Culture Media, Propagating Transport

Devices cleared under the same product code (JSN) and FDA review panel - the closest regulatory comparables to K881579.
CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM
K961755 · Proteins Intl., Inc. · May 1996
CYTOQUANT VIRAL TRANSPORT MEDIUM
K961756 · Proteins Intl., Inc. · May 1996
10B
K833968 · Remel Co. · Dec 1983
A3B
K834065 · Remel Co. · Dec 1983
TRANSPORT MEDIA
K781304 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1978