Cleared Traditional

K811777 - HELENA PLASMINOGEN QUIPLATE PROCEDURE

K811777 is an FDA 510(k) clearance for HELENA PLASMINOGEN QUIPLATE PROCEDURE, manufactured by Helena Laboratories. The device is a Class 1 Immunology device with product code DDX cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K811777 · Helena Laboratories · Immunology device
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Jul 1981
Decision
9d
Days
Class 1
Risk

K811777 is an FDA 510(k) clearance for the HELENA PLASMINOGEN QUIPLATE PROCEDURE. Classified as Plasminogen, Antigen, Antiserum, Control (product code DDX), Class I - General Controls.

Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on July 2, 1981 after a review of 9 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 Helena Laboratories devices

FDA 510(k) Submission Details - K811777

510(k) Number K811777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1981
Decision Date July 02, 1981
Days to Decision 9 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
96d faster than avg
Panel avg: 105d · This submission: 9d
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 8
Devices cleared under the same product code (DDX) and FDA review panel - the closest regulatory comparables to K811777.
GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY
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
PLASMINOGEN ASSAY
K781478 · Dade, Baxter Travenol Diagnostics, Inc. · Nov 1978
LAS-R HUMAN PLASMINOGEN TEST
K772085 · Hyland Therapeutic Div., Travenol Laboratories · Jan 1978