Cleared Traditional

IL TEST 97573-15, PLASMINOGEN ASSAY (K864212) - FDA 510(k) Clearance

Class I Hematology device.

K864212 · Instrumentation Laboratory CO · Hematology device
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Dec 1986
Decision
37d
Days
Class 1
Risk

K864212 is an FDA 510(k) clearance for the IL TEST 97573-15, PLASMINOGEN ASSAY. Classified as Plasminogen, Antigen, Antiserum, Control (product code DDX), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on December 4, 1986 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 866.5715 - 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.

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Submission Details

510(k) Number K864212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1986
Decision Date December 04, 1986
Days to Decision 37 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 113d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DDX Plasminogen, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5715
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.