510(k) · Cleared

Cleared

Access Ferritin

K234052510(k) TraditionalCleared Mar 20, 202490-day reviewClass II21 CFR 866.5340

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Beckman Coulter, Inc. · JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin

Cleared on Mar 20, 2024 as substantially equivalent to K926221 (Bio-Rad Laboratories, Inc., 1993) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1993.

Decided: Mar 20, 2024
Review: 90 days
Class: Class II
Product code: JMG
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K926221 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK926221 Access Ferritin AssayBio-Rad Laboratories, Inc. · 1993 · Recalled
1 generation backK052082 Ferritin on the Access Immunoassay Systems, Model 33020Beckman Coulter, Inc. · 2005 · Recalled
This deviceK234052 Access FerritinBeckman Coulter, Inc. · 2024

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K926221	Access Ferritin Assay	Bio-Rad Laboratories, Inc.	1993	1
−1	K052082	Ferritin on the Access Immunoassay Systems, Model 33020	Beckman Coulter, Inc.	2005	1
0 (this device)	K234052	Access Ferritin	Beckman Coulter, Inc.	2024	—

FIG. 1 — Lineage of K234052, 1993–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JMG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K926221	Access Ferritin Assay Summary page 4 …Name: Access Ferritin Common Name: Ferritin Classification Regulation: 21 CFR 866.5340 Classification Product Code: JMG Predicate Device: Access Ferritin 510(k) Number K926221, k052082 Device Description The Access Ferritin assay is a sandwich immunoenzymatic assay. The Access Ferritin assay consists o…	Bio-Rad Laboratories, Inc.	1993	1
*	K052082	Ferritin on the Access Immunoassay Systems, Model 33020 Summary page 4 …cess Ferritin Common Name: Ferritin Classification Regulation: 21 CFR 866.5340 Classification Product Code: JMG Predicate Device: Access Ferritin 510(k) Number K926221, k052082 Device Description The Access Ferritin assay is a sandwich immunoenzymatic assay. The Access Ferritin assay consists of the rea…	Beckman Coulter, Inc.	2005	1

Also cleared against K926221: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 31 years and passes through 2 companies; a new generation was cleared every 18.6 years on median.
2 of the 2 ancestors have a recall of any class.
4 other devices also cite its predicate K926221.

How does its category compare?

All JMG devices

JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · JMG

1in 2024

2007high 1 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JMG

Too few JMG 510(k)s in any year since 2007 to give a median.

Recalls per year · JMG

1in 2025

2007high 1 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JMG

12in 2025

2007high 13 (2023) · low 0 (2007)2025

MAUDE reports naming product code JMG, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	1
2011	0	—	0	0
2012	0	—	0	0
2013	0	—	1	12
2014	0	—	0	2
2015	0	—	0	0
2016	0	—	0	1
2017	0	—	0	1
2018	0	—	0	3
2019	0	—	0	1
2020	0	—	0	4
2021	0	—	0	5
2022	0	—	0	2
2023	0	—	0	13
2024	1	—	0	11
2025	0	—	1	12
2026	0	—	0	—

What is it indicated for?

The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems.

Ferritin is used as an aid in the diagnosis of iron deficiency or iron overload.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K234052 · printed Nov 4, 2026

Cite this page

510(k) Report. “K234052: Access Ferritin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K234052

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026