Cleared Traditional

K843817 - BIOTIS MARTIN LEWIS AGAR

K843817 is the FDA 510(k) clearance for BIOTIS MARTIN LEWIS AGAR by Otisville Biotech, Inc.. It is a Class 2 Microbiology device (product code JTY) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K843817 · Otisville Biotech, Inc. · Microbiology device
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Oct 1984
Decision
12d
Days
Class 2
Risk

K843817 is an FDA 510(k) clearance for the BIOTIS MARTIN LEWIS AGAR. Classified as Culture Media, For Isolation Of Pathogenic Neisseria (product code JTY), Class II - Special Controls.

Submitted by Otisville Biotech, Inc. (Otisville, US). The FDA issued a Cleared decision on October 10, 1984 after a review of 12 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 Otisville Biotech, Inc. devices

Submission Details

510(k) Number K843817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1984
Decision Date October 10, 1984
Days to Decision 12 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
90d faster than avg
Panel avg: 102d · This submission: 12d
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 K843817.
MODIFIED N.Y.C. FERMENTATION MEDIUM BASE
K864078 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1986
BIOTIS MODIFIED THAYER MARTIN
K860384 · Otisville Biotech, Inc. · Feb 1986
MOD THAYER MARTIN MARTIN LEWIS
K850841 · Micro Media Laboratories · Mar 1985
CHOCOLATE AGAR GC BASE PLATE
K840065 · Otisville Biotech, Inc. · Feb 1984
THAYER-MARTIN AGAR PLATE
K840067 · Otisville Biotech, Inc. · Feb 1984
NYC-GC MEDIA
K832948 · Otisville Biotech, Inc. · Sep 1983