Cleared Traditional

K981478 - ACS:CENTAUR CEA

K981478 is the FDA 510(k) clearance for ACS:CENTAUR CEA by Chiron Diagnostics Corp.. It is a Class 2 Immunology device (product code DHX) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K981478 · Chiron Diagnostics Corp. · Immunology device
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Optimized for regulatory review, auditing and printing
Aug 1998
Decision
110d
Days
Class 2
Risk

K981478 is an FDA 510(k) clearance for the ACS:CENTAUR CEA. Classified as System, Test, Carcinoembryonic Antigen (product code DHX), Class II - Special Controls.

Submitted by Chiron Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on August 12, 1998 after a review of 110 days - within the typical 510(k) review window.

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 Chiron Diagnostics Corp. devices

Submission Details

510(k) Number K981478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1998
Decision Date August 12, 1998
Days to Decision 110 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 104d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K981478.
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK
K990943 · Ortho-Clinical Diagnostics, Inc. · Jun 1999
ABBOTT ARCHITECT CEA
K990774 · Abbott Laboratories · May 1999
ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209
K981985 · Beckman Coulter, Inc. · Sep 1998
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