Cleared Special

FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 (K052082) - FDA 510(k) Clearance

Class II Immunology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K052082 · Beckman Coulter, Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
Aug 2005
Decision
17d
Days
Class 2
Risk

K052082 is an FDA 510(k) clearance for the FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020. Classified as Radioimmunoassay (two-site Solid Phase), Ferritin (product code JMG), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on August 19, 2005 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5340 - 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 Coulter, Inc. devices

Submission Details

510(k) Number K052082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2005
Decision Date August 19, 2005
Days to Decision 17 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
87d faster than avg
Panel avg: 104d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JMG Radioimmunoassay (two-site Solid Phase), Ferritin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5340
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 - JMG Radioimmunoassay (two-site Solid Phase), Ferritin

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