Cleared Traditional

K812625 - ACA PLASMINOGEN TEST PACK

K812625 is the FDA 510(k) clearance for ACA PLASMINOGEN TEST PACK by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 1 Immunology device (product code DDX) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K812625 · E.I. Dupont DE Nemours & Co., Inc. · Immunology device
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Sep 1981
Decision
14d
Days
Class 1
Risk

K812625 is an FDA 510(k) clearance for the ACA PLASMINOGEN TEST PACK. Classified as Plasminogen, Antigen, Antiserum, Control (product code DDX), Class I - General Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1981 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5715 - the FDA immunology 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K812625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1981
Decision Date September 29, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 104d · This submission: 14d
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.

Regulatory Peers - DDX Plasminogen, Antigen, Antiserum, Control

All 7
Devices cleared under the same product code (DDX) and FDA review panel - the closest regulatory comparables to K812625.
BERICHROM(R) PLASMINOGEN
K884766 · Behring Diagnostics, Inc. · Jan 1989
IL TEST 97573-15, PLASMINOGEN ASSAY
K864212 · Instrumentation Laboratory CO · Dec 1986
GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY
K850410 · Warner-Lambert Co. · May 1985
HELENA PLASMINOGEN QUIPLATE PROCEDURE
K811777 · Helena Laboratories · Jul 1981
PLASMINOGEN ASSAY
K781478 · Dade, Baxter Travenol Diagnostics, Inc. · Nov 1978
LAS-R HUMAN PLASMINOGEN TEST
K772085 · Hyland Therapeutic Div., Travenol Laboratories · Jan 1978