Cleared Traditional

K990774 - ABBOTT ARCHITECT CEA

K990774 is an FDA 510(k) clearance for ABBOTT ARCHITECT CEA, manufactured by Abbott Laboratories. The device is a Class 2 Immunology device with product code DHX cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K990774 · Abbott Laboratories · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
63d
Days
Class 2
Risk

K990774 is an FDA 510(k) clearance for the ABBOTT ARCHITECT CEA. Classified as System, Test, Carcinoembryonic Antigen (product code DHX), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 11, 1999 after a review of 63 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K990774

510(k) Number K990774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1999
Decision Date May 11, 1999
Days to Decision 63 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
41d faster than avg
Panel avg: 104d · This submission: 63d
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 K990774.
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ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209
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ELECSYS CEA ON THE ELECSYS 1010
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IMMULITE CEA
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