Cleared Special

K991707 - MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33200, 33205, 33209, 33206

K991707 is an FDA 510(k) clearance for MODIFICATION TO ACCESS CEA REAGENTS FOR..., manufactured by Beckman. The device is a Class 2 Immunology device with product code DHX cleared through the Special 510(k) pathway after a 13-day FDA review.

K991707 · Beckman · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
13d
Days
Class 2
Risk

K991707 is an FDA 510(k) clearance for the MODIFICATION TO ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZE.... Classified as System, Test, Carcinoembryonic Antigen (product code DHX), Class II - Special Controls.

Submitted by Beckman (Chaska, US). The FDA issued a Cleared decision on June 1, 1999 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Beckman devices

FDA 510(k) Submission Details - K991707

510(k) Number K991707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1999
Decision Date June 01, 1999
Days to Decision 13 days
Submission Type Special
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
92d faster than avg
Panel avg: 105d · This submission: 13d
Pathway characteristics
Modification to existing cleared device.

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 K991707.
ST AIA-PACK CEA ENZYME IMMUNOASSAY
K023893 · Tosoh Medics, Inc. · Dec 2002
CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K013568 · Bayer Corp. · Dec 2001
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
ACS:CENTAUR CEA
K981478 · Chiron Diagnostics Corp. · Aug 1998