Cleared Traditional

K854572 - COATEST PLASMINOGEN

K854572 is an FDA 510(k) clearance for COATEST PLASMINOGEN, manufactured by Kabivitrum, Inc.. The device is a Class 1 Hematology device with product code DDX cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K854572 · Kabivitrum, Inc. · Hematology device
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Feb 1986
Decision
104d
Days
Class 1
Risk

K854572 is an FDA 510(k) clearance for the COATEST PLASMINOGEN. Classified as Plasminogen, Antigen, Antiserum, Control (product code DDX), Class I - General Controls.

Submitted by Kabivitrum, Inc. (Alameda, US). The FDA issued a Cleared decision on February 26, 1986 after a review of 104 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kabivitrum, Inc. devices

FDA 510(k) Submission Details - K854572

510(k) Number K854572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1985
Decision Date February 26, 1986
Days to Decision 104 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 113d · This submission: 104d
Pathway characteristics
Predicate-based equivalence.

DDX Device Classification - Class 1, General Controls

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.

Regulatory Peers - DDX Plasminogen, Antigen, Antiserum, Control

All 9
Devices cleared under the same product code (DDX) and FDA review panel - the closest regulatory comparables to K854572.
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K864212 · Instrumentation Laboratory CO · Dec 1986
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K850410 · Warner-Lambert Co. · May 1985
DIACROM *PLG
K832591 · Wellcome Diagnostics · Nov 1983
ACA PLASMINOGEN TEST PACK
K812625 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1981