Cleared Traditional

K832591 - DIACROM *PLG

K832591 is an FDA 510(k) clearance for DIACROM *PLG, manufactured by Wellcome Diagnostics. The device is a Class 1 Immunology device with product code DDX cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K832591 · Wellcome Diagnostics · Immunology device
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Nov 1983
Decision
111d
Days
Class 1
Risk

K832591 is an FDA 510(k) clearance for the DIACROM *PLG. Classified as Plasminogen, Antigen, Antiserum, Control (product code DDX), Class I - General Controls.

Submitted by Wellcome Diagnostics (Mchenry, US). The FDA issued a Cleared decision on November 21, 1983 after a review of 111 days - within the typical 510(k) review window.

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 Wellcome Diagnostics devices

FDA 510(k) Submission Details - K832591

510(k) Number K832591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1983
Decision Date November 21, 1983
Days to Decision 111 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
6d slower than avg
Panel avg: 105d · This submission: 111d
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 K832591.
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