Cleared Traditional

K861312 - LYFO-KWIK (TM) COAGULASE PLASMA

K861312 is the FDA 510(k) clearance for LYFO-KWIK (TM) COAGULASE PLASMA by Micro-Bio-Logics. It is a Class 1 Hematology device (product code JTL) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K861312 · Micro-Bio-Logics · Hematology device
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Apr 1986
Decision
10d
Days
Class 1
Risk

K861312 is an FDA 510(k) clearance for the LYFO-KWIK (TM) COAGULASE PLASMA. Classified as Plasma, Coagulase, Human, Horse And Rabbit (product code JTL), Class I - General Controls.

Submitted by Micro-Bio-Logics (St. Cloud, US). The FDA issued a Cleared decision on April 18, 1986 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 866.2160 - the FDA hematology 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 K861312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1986
Decision Date April 18, 1986
Days to Decision 10 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 113d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTL Plasma, Coagulase, Human, Horse And Rabbit
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2160
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 - JTL Plasma, Coagulase, Human, Horse And Rabbit

All 8
Devices cleared under the same product code (JTL) and FDA review panel - the closest regulatory comparables to K861312.
DRYSLIDE COAGULASE
K950706 · Difco Laboratories, Inc. · May 1995
RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122
K870945 · Oxoid U.S.A., Inc. · Jun 1987
HEMASTAPH
K840553 · Remel Co. · Apr 1984
API STAPHASE III
K833988 · Analytical Products, Inc. · Dec 1983
COAGULASE PLASMA, HORSE & RABBIT EDTA
K833858 · Otisville Biotech, Inc. · Dec 1983
RABBIT COAGULASE PLASMA
K812602 · Dutchland Laboratories, Inc. · Sep 1981