Cleared Traditional

K840065 - CHOCOLATE AGAR GC BASE PLATE

K840065 is an FDA 510(k) clearance for CHOCOLATE AGAR GC BASE PLATE, manufactured by Otisville Biotech, Inc.. The device is a Class 2 Microbiology device with product code JTY cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K840065 · Otisville Biotech, Inc. · Microbiology device
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Feb 1984
Decision
35d
Days
Class 2
Risk

K840065 is an FDA 510(k) clearance for the CHOCOLATE AGAR GC BASE PLATE. Classified as Culture Media, For Isolation Of Pathogenic Neisseria (product code JTY), Class II - Special Controls.

Submitted by Otisville Biotech, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1984 after a review of 35 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.

FDA 510(k) Submission Details - K840065

510(k) Number K840065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1984
Decision Date February 13, 1984
Days to Decision 35 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
67d faster than avg
Panel avg: 102d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JTY Device Classification - Class 2, Special Controls

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 82
Devices cleared under the same product code (JTY) and FDA review panel - the closest regulatory comparables to K840065.
MARTIN-LEWIS AGAR
K841750 · The Montana Deaconess Medical Center · May 1984
CULTURE MEDIUM FOR PATHOGENIC NEISSER
K841833 · Microline Scientific · May 1984
CULTURE MEDIUM FOR PATHOGENIC NEISSER
K840970 · Chatham Biological · Apr 1984
THAYER-MARTIN AGAR PLATE
K840067 · Otisville Biotech, Inc. · Feb 1984
GC-TECT
K840159 · Uti-Tect, Inc. · Jan 1984
THAYER MARTIN AGAR
K833862 · American Biomedical Corp. · Dec 1983
K840065 · CHOCOLATE AGAR GC BASE PLATE
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