Cleared Traditional

K981985 - ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209

K981985 is an FDA 510(k) clearance for ACCESS CEA REAGENTS ON THE ACCESS IMMUN..., manufactured by Beckman Coulter, Inc.. The device is a Class 2 Immunology device with product code DHX cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K981985 · Beckman Coulter, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
111d
Days
Class 2
Risk

K981985 is an FDA 510(k) clearance for the ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33.... Classified as System, Test, Carcinoembryonic Antigen (product code DHX), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on September 24, 1998 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 866.6010 - 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 Beckman Coulter, Inc. devices

FDA 510(k) Submission Details - K981985

510(k) Number K981985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1998
Decision Date September 24, 1998
Days to Decision 111 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
6d slower than avg
Panel avg: 105d · This submission: 111d
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 23
Devices cleared under the same product code (DHX) and FDA review panel - the closest regulatory comparables to K981985.
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC PRODUCTS CEA REAGENT PACK
K990943 · Ortho-Clinical Diagnostics, Inc. · Jun 1999
MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206
K991707 · Beckman · Jun 1999
ABBOTT ARCHITECT CEA
K990774 · Abbott Laboratories · May 1999
ACS:CENTAUR CEA
K981478 · Chiron Diagnostics Corp. · Aug 1998
ELECSYS CEA ON THE ELECSYS 1010
K980887 · Boehringer Mannheim Corp. · Jun 1998
IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT
K980855 · Dpc Cirrus · Apr 1998