Cleared Traditional

K811394 - CEA DESALTING DOLUMN SEPHADEX R

K811394 is an FDA 510(k) clearance for CEA DESALTING DOLUMN SEPHADEX R, manufactured by Immuno-Diagnostic Laboratories. The device is a Class 2 Chemistry device with product code DHX cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K811394 · Immuno-Diagnostic Laboratories · Chemistry device
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Jun 1981
Decision
25d
Days
Class 2
Risk

K811394 is an FDA 510(k) clearance for the CEA DESALTING DOLUMN SEPHADEX R. Classified as System, Test, Carcinoembryonic Antigen (product code DHX), Class II - Special Controls.

Submitted by Immuno-Diagnostic Laboratories (Mchenry, US). The FDA issued a Cleared decision on June 12, 1981 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.6010 - the FDA in vitro diagnostics and chemistry 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 Immuno-Diagnostic Laboratories devices

FDA 510(k) Submission Details - K811394

510(k) Number K811394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1981
Decision Date June 12, 1981
Days to Decision 25 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 88d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHX Device Classification - Class 2, Special Controls

Product Code DHX System, Test, Carcinoembryonic Antigen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - DHX System, Test, Carcinoembryonic Antigen

All 24
Devices cleared under the same product code (DHX) and FDA review panel - the closest regulatory comparables to K811394.
CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV
K820298 · Ventrex Laboratories, Inc. · Apr 1982
CEA CONTROL PLASMA
K812658 · Pacific Hemostasis · Sep 1981
THREE LEVEL CONTROL SERA
K810459 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1981
AMICON ULTRAFILTRATION MEMBRANES CMII
K810810 · Amicon, Inc. · Apr 1981