Cleared Traditional

K864877 - TRI-LEVEL LIGAND CONTROL

K864877 is an FDA 510(k) clearance for TRI-LEVEL LIGAND CONTROL, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 2 Immunology device with product code DHX cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K864877 · Ciba Corning Diagnostics Corp. · Immunology device
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May 1987
Decision
160d
Days
Class 2
Risk

K864877 is an FDA 510(k) clearance for the TRI-LEVEL LIGAND CONTROL. Classified as System, Test, Carcinoembryonic Antigen (product code DHX), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on May 21, 1987 after a review of 160 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - 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 Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K864877

510(k) Number K864877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1986
Decision Date May 21, 1987
Days to Decision 160 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
56d slower than avg
Panel avg: 104d · This submission: 160d
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 Immunology devices follow this clearance model.

Regulatory Peers - DHX System, Test, Carcinoembryonic Antigen

All 19
Devices cleared under the same product code (DHX) and FDA review panel - the closest regulatory comparables to K864877.
ELECSYS CEA ON THE ELECSYS 1010
K980887 · Boehringer Mannheim Corp. · Jun 1998
IMMULITE CEA
K970877 · Diagnostic Products Corp. · Sep 1997
AIA-PACK CEA CALIBRATION VERIFICATION TEST SET
K924857 · Tosoh Medics, Inc. · Mar 1993
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