Cleared Traditional

K234052 - Access Ferritin

K234052 is an FDA 510(k) clearance for Access Ferritin, manufactured by Beckman Coulter, Inc.. The device is a Class 2 Immunology device with product code JMG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K234052 · Beckman Coulter, Inc. · Immunology device
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Mar 2024
Decision
90d
Days
Class 2
Risk

K234052 is an FDA 510(k) clearance for the Access Ferritin. 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 March 20, 2024 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5340 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Beckman Coulter, Inc. devices

FDA 510(k) Submission Details - K234052

510(k) Number K234052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2023
Decision Date March 20, 2024
Days to Decision 90 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
15d faster than avg
Panel avg: 105d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JMG Device Classification - Class 2, Special Controls

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

All 20
Devices cleared under the same product code (JMG) and FDA review panel - the closest regulatory comparables to K234052.
FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020
K052082 · Beckman Coulter, Inc. · Aug 2005
TINA-QUANT FERRITIN ASSAY
K964282 · Boehringer Mannheim Corp. · Jul 1997
ELECSYS FERRITIN
K971833 · Boehringer Mannheim Corp. · Jun 1997
FERR FLEX REAGENT CARTRIDGE
K963498 · Dade Chemistry Systems, Inc. · Jan 1997
ACE(TM) CEDIA(R) FERRITIN ASSAY
K950393 · Schiapparelli Biosystems, Inc. · May 1995
IMMULITE FERRITIN
K925848 · Diagnostic Products Corp. · Jan 1993