Cleared Traditional

K860384 - BIOTIS MODIFIED THAYER MARTIN

K860384 is an FDA 510(k) clearance for BIOTIS MODIFIED THAYER MARTIN, 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 21-day FDA review.

K860384 · Otisville Biotech, Inc. · Microbiology device
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Feb 1986
Decision
21d
Days
Class 2
Risk

K860384 is an FDA 510(k) clearance for the BIOTIS MODIFIED THAYER MARTIN. 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 February 24, 1986 after a review of 21 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

FDA 510(k) Submission Details - K860384

510(k) Number K860384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1986
Decision Date February 24, 1986
Days to Decision 21 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
81d faster than avg
Panel avg: 102d · This submission: 21d
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 59
Devices cleared under the same product code (JTY) and FDA review panel - the closest regulatory comparables to K860384.
THAYER MARTIN AGAR
K864253 · Mds Laboratories, Inc. · Mar 1987
GC-LECT(TM)
K864803 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1987
MODIFIED N.Y.C. FERMENTATION MEDIUM BASE
K864078 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1986
APL MARTIN LEWIS MEDIUM
K853237 · Apl Medical Supplies · Aug 1985
CHOCOLATE MUELLER HINTON AGAR
K851579 · Preferred Micro-Media · May 1985
THAYER MARTIN AGAR & MODIFIED THAYER AGAR
K851587 · Preferred Micro-Media · Apr 1985