Cleared Traditional

BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI (K874173) - FDA 510(k) Clearance

Class I Microbiology device.

K874173 · Otisville Biopharm, Inc. · Microbiology device
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Oct 1987
Decision
15d
Days
Class 1
Risk

K874173 is an FDA 510(k) clearance for the BIOTIS (TM) BHI WITH HRBC, CHLORA/GENTAM/CYCLOHEXI. Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Otisville Biopharm, Inc. (Otisville, US). The FDA issued a Cleared decision on October 28, 1987 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2360 - 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 Biopharm, Inc. devices

Submission Details

510(k) Number K874173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1987
Decision Date October 28, 1987
Days to Decision 15 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 102d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSJ Culture Media, Selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSJ Culture Media, Selective And Non-differential

All 306
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K874173.
GBNA MEDIUM
K871786 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1987
MRS AGAR AND MRS BROTH
K871702 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1987
MCBRIDE AGAR, MODIFIED
K871357 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1987
ANAEROBIC PEA BLOOD AGAR
K871090 · bioMerieux, Inc. · Apr 1987
BACTEROIDES BILE ESCULIN AGAR
K871091 · bioMerieux, Inc. · Apr 1987
CHOCOLATE AGAR W/BACITRACIN (HAEM. ISOL. AGAR)
K871093 · bioMerieux, Inc. · Apr 1987