Cleared Traditional

ADVIA Centaur CEA Assay (K200215) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200215 · Siemens Healthcare Disgnostics, Inc. · Immunology device
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Apr 2020
Decision
76d
Days
Class 2
Risk

K200215 is an FDA 510(k) clearance for the ADVIA Centaur CEA Assay. Classified as System, Test, Carcinoembryonic Antigen (product code DHX), Class II - Special Controls.

Submitted by Siemens Healthcare Disgnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on April 13, 2020 after a review of 76 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 Siemens Healthcare Disgnostics, Inc. devices

Submission Details

510(k) Number K200215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2020
Decision Date April 13, 2020
Days to Decision 76 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
28d faster than avg
Panel avg: 104d · This submission: 76d
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 27
Devices cleared under the same product code (DHX) and FDA review panel - the closest regulatory comparables to K200215.
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K990774 · Abbott Laboratories · May 1999
THREE LEVEL CONTROL SERA
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