Cleared Traditional

KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS (K861022) - FDA 510(k) Clearance

Class I Microbiology device.

K861022 · Micro-Bio-Logics · Microbiology device
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Apr 1986
Decision
17d
Days
Class 1
Risk

K861022 is an FDA 510(k) clearance for the KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMS. Classified as Kit, Quality Control For Culture Media (product code JTR), Class I - General Controls.

Submitted by Micro-Bio-Logics (St. Cloud, US). The FDA issued a Cleared decision on April 4, 1986 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2480 - 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 Micro-Bio-Logics devices

Submission Details

510(k) Number K861022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1986
Decision Date April 04, 1986
Days to Decision 17 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 102d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTR Kit, Quality Control For Culture Media
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2480
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.