Cleared Traditional

K941346 - PLASMINOGEN RID TEST KIT

K941346 is the FDA 510(k) clearance for PLASMINOGEN RID TEST KIT by The Binding Site, Ltd.. It is a Class 1 Immunology device (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

Submission Details

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
68d slower than avg
Panel avg: 104d · This submission: 172d
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 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
ACA PLASMINOGEN TEST PACK
K812625 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1981
HELENA PLASMINOGEN QUIPLATE PROCEDURE
K811777 · Helena Laboratories · Jul 1981
PLASMINOGEN ASSAY
K781478 · Dade, Baxter Travenol Diagnostics, Inc. · Nov 1978