Cleared Traditional

K941346 - PLASMINOGEN RID TEST KIT

K941346 is an FDA 510(k) clearance for PLASMINOGEN RID TEST KIT, manufactured by The Binding Site, Ltd.. The device is a Class 1 Immunology device with product code DDX cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K941346 · The Binding Site, Ltd. · Immunology device
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Sep 1994
Decision
172d
Days
Class 1
Risk

K941346 is an FDA 510(k) clearance for the PLASMINOGEN RID TEST KIT. Classified as Plasminogen, Antigen, Antiserum, Control (product code DDX), Class I - General Controls.

Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on September 9, 1994 after a review of 172 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all The Binding Site, Ltd. devices

FDA 510(k) Submission Details - K941346

510(k) Number K941346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1994
Decision Date September 09, 1994
Days to Decision 172 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 105d · This submission: 172d
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 K941346.
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
DIACROM *PLG
K832591 · Wellcome Diagnostics · Nov 1983
ACA PLASMINOGEN TEST PACK
K812625 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1981
HELENA PLASMINOGEN QUIPLATE PROCEDURE
K811777 · Helena Laboratories · Jul 1981