Cleared Traditional

K811051 - TRYPTIC SOY AGAR

K811051 is the FDA 510(k) clearance for TRYPTIC SOY AGAR by Acumedia Manufacturers, Inc.. It is a Class 1 Microbiology device (product code JSG) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K811051 · Acumedia Manufacturers, Inc. · Microbiology device
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Apr 1981
Decision
13d
Days
Class 1
Risk

K811051 is an FDA 510(k) clearance for the TRYPTIC SOY AGAR. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Acumedia Manufacturers, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 29, 1981 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2300 - 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 K811051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1981
Decision Date April 29, 1981
Days to Decision 13 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
89d faster than avg
Panel avg: 102d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
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 - JSG Culture Media, Non-selective And Non-differential

All 175
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K811051.
COLUMBIA BLOOD AGAR BASE
K811135 · Acumedia Manufacturers, Inc. · May 1981
TRYPTIC SOY AGAR W/LECITHIN & TWEEN 80
K811052 · Acumedia Manufacturers, Inc. · May 1981
TRYPTIC SOY BROTH
K811050 · Acumedia Manufacturers, Inc. · Apr 1981
PEDIATRIC BLOOD CULTURE BOTTLES
K810553 · Gibco Laboratories Life Technologies, Inc. · Mar 1981
ENRICHED THIOGLYCOLLATE MEDIUM
K803023 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1980
CDC ANAEROBE BLOOD AGAR
K803025 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1980