Cleared Traditional

K980887 - ELECSYS CEA ON THE ELECSYS 1010

K980887 is an FDA 510(k) clearance for ELECSYS CEA ON THE ELECSYS 1010, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Immunology device with product code DHX cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K980887 · Boehringer Mannheim Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
112d
Days
Class 2
Risk

K980887 is an FDA 510(k) clearance for the ELECSYS CEA ON THE ELECSYS 1010. Classified as System, Test, Carcinoembryonic Antigen (product code DHX), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Pleasanton, US). The FDA issued a Cleared decision on June 29, 1998 after a review of 112 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K980887

510(k) Number K980887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1998
Decision Date June 29, 1998
Days to Decision 112 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 104d · This submission: 112d
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 K980887.
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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
IMMULITE CEA
K970877 · Diagnostic Products Corp. · Sep 1997
AIA-PACK CEA CALIBRATION VERIFICATION TEST SET
K924857 · Tosoh Medics, Inc. · Mar 1993
TRI-LEVEL LIGAND CONTROL
K864877 · Ciba Corning Diagnostics Corp. · May 1987