Cleared Traditional

CULTURE MEDIUM FOR PATHOGENIC NEISSER (K841833) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K841833 · Microline Scientific · Microbiology device
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May 1984
Decision
27d
Days
Class 2
Risk

K841833 is an FDA 510(k) clearance for the CULTURE MEDIUM FOR PATHOGENIC NEISSER. Classified as Culture Media, For Isolation Of Pathogenic Neisseria (product code JTY), Class II - Special Controls.

Submitted by Microline Scientific (Mchenry, US). The FDA issued a Cleared decision on May 14, 1984 after a review of 27 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 Microline Scientific devices

Submission Details

510(k) Number K841833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1984
Decision Date May 14, 1984
Days to Decision 27 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 102d · This submission: 27d
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 10
Devices cleared under the same product code (JTY) and FDA review panel - the closest regulatory comparables to K841833.
PROTEOSE NO. 3 AGAR
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GC-LECT(TM)
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MODIFIED N.Y.C. FERMENTATION MEDIUM BASE
K864078 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1986
THAYER-MARTIN, MODIFIED
K830061 · bioMerieux, Inc. · Feb 1983
MARTIN-LEWIS AGAR
K830062 · bioMerieux, Inc. · Feb 1983
GONOZYME (10 COPIES FRWD. W/ORIG. TO BG)
K812078 · Abbott Laboratories · Jul 1981