Cleared Traditional

K851586 - MACCONKEY AGAR

K851586 is an FDA 510(k) clearance for MACCONKEY AGAR, manufactured by Preferred Micro-Media. The device is a Class 1 Microbiology device with product code JSI cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K851586 · Preferred Micro-Media · Microbiology device
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Apr 1985
Decision
14d
Days
Class 1
Risk

K851586 is an FDA 510(k) clearance for the MACCONKEY AGAR. Classified as Culture Media, Selective And Differential (product code JSI), Class I - General Controls.

Submitted by Preferred Micro-Media (Toledo, US). The FDA issued a Cleared decision on April 30, 1985 after a review of 14 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 Preferred Micro-Media devices

FDA 510(k) Submission Details - K851586

510(k) Number K851586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1985
Decision Date April 30, 1985
Days to Decision 14 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
88d faster than avg
Panel avg: 102d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

JSI Device Classification - Class 1, General Controls

Product Code JSI Culture Media, Selective And 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 - JSI Culture Media, Selective And Differential

All 232
Devices cleared under the same product code (JSI) and FDA review panel - the closest regulatory comparables to K851586.
HEKTOEN ENTERIC AGAR
K851583 · Preferred Micro-Media · May 1985
LEVINE EMB AGAR
K851584 · Preferred Micro-Media · Apr 1985
MANNITOL SALT AGAR
K851585 · Preferred Micro-Media · Apr 1985
BIOTIS CHOCOLATE TELLURITE
K850565 · Otisville Biotech, Inc. · Mar 1985
BILE ESCULIN AGAR W/AZIDE, BEA W/AZIDE
K850552 · Hardy Media · Mar 1985
BRILLANT GREEN AGAR
K844930 · American Laboratory Supply, Inc. · Feb 1985