Cleared Traditional

K811053 - GC AGAR

K811053 is the FDA 510(k) clearance for GC AGAR by Acumedia Manufacturers, Inc.. It is a Class 2 Microbiology device (product code JTY) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K811053 · Acumedia Manufacturers, Inc. · Microbiology device
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Apr 1981
Decision
13d
Days
Class 2
Risk

K811053 is an FDA 510(k) clearance for the GC AGAR. Classified as Culture Media, For Isolation Of Pathogenic Neisseria (product code JTY), Class II - Special 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 866.2410 - 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 K811053 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. No clinical trials required.

Device Classification

Product Code JTY Culture Media, For Isolation Of Pathogenic Neisseria
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.2410
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 - JTY Culture Media, For Isolation Of Pathogenic Neisseria

All 46
Devices cleared under the same product code (JTY) and FDA review panel - the closest regulatory comparables to K811053.
GONOZYME (10 COPIES FRWD. W/ORIG. TO BG)
K812078 · Abbott Laboratories · Jul 1981
THAYER-MARTIN, GC AGAR BASE
K811645 · Hardy Media · Jul 1981
LAB-TEK JEMBEC G.C. CULTURE SYSTEM
K811382 · Miles Laboratories, Inc. · Jun 1981
MODIFIED THAYER-MARTIN X AGAR
K800333 · Isle Media and Sterile Products, Inc. · Mar 1980
MARTIN-LEWIS AGAR
K800334 · Isle Media and Sterile Products, Inc. · Mar 1980
MODIFIED THAYER-MARTIN AGAR (PLATE)
K791425 · American Laboratory Supply, Inc. · Sep 1979