Cleared Traditional

K860401 - BIOTIS TRYPTIC SOY AGAR SLANTS

K860401 is the FDA 510(k) clearance for BIOTIS TRYPTIC SOY AGAR SLANTS by Otisville Biotech, Inc.. It is a Class 1 Microbiology device (product code JSG) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K860401 · Otisville Biotech, Inc. · Microbiology device
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Feb 1986
Decision
21d
Days
Class 1
Risk

K860401 is an FDA 510(k) clearance for the BIOTIS TRYPTIC SOY AGAR SLANTS. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General 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 866.2300 - 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 Otisville Biotech, Inc. devices

Submission Details

510(k) Number K860401 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.

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 K860401.
CHARCOAL AGAR BASE
K861480 · Gibco Laboratories Life Technologies, Inc. · May 1986
BIOTIS TSA
K860397 · Otisville Biotech, Inc. · Feb 1986
BIOTIS TODD HEWITT BROTH
K860399 · Otisville Biotech, Inc. · Feb 1986
BIOTIS TSA WITH 5% RABBIT BLOOD
K860403 · Otisville Biotech, Inc. · Feb 1986
BIOTIS NUTRIENT AGAR
K860408 · Otisville Biotech, Inc. · Feb 1986
BIOTIS COLUMBIA SHEEP BLOOD AGAR
K860409 · Otisville Biotech, Inc. · Feb 1986