Cleared Traditional

K980855 - IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT

K980855 is an FDA 510(k) clearance for IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN ..., manufactured by Dpc Cirrus. The device is a Class 2 Immunology device with product code DHX cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K980855 · Dpc Cirrus · Immunology device
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Apr 1998
Decision
47d
Days
Class 2
Risk

K980855 is an FDA 510(k) clearance for the IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT. Classified as System, Test, Carcinoembryonic Antigen (product code DHX), Class II - Special Controls.

Submitted by Dpc Cirrus (Randolph, US). The FDA issued a Cleared decision on April 21, 1998 after a review of 47 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 Dpc Cirrus devices

FDA 510(k) Submission Details - K980855

510(k) Number K980855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1998
Decision Date April 21, 1998
Days to Decision 47 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 105d · This submission: 47d
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 K980855.
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