510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Access Ferritin Assay

K926221510(k) TraditionalCleared Jan 13, 199334-day reviewClass II21 CFR 866.5340Recalls 1

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

Bio-Rad Laboratories, Inc. · JMG Radioimmunoassay (Two-Site Solid Phase), Ferritin

Cleared on Jan 13, 1993 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it. It has been recalled once.

Decided
Jan 13, 1993
Review
34 days
Class
Class II
Product code
JMG
Recalls
1
Predicates
0

13 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2019: 2 descendants cleared2009: 1 descendant cleared2024: 2 descendants cleared2005: 1 descendant cleared2011: 1 descendant cleared1999: 2 descendants cleared1998: 1 descendant cleared2008: 1 descendant cleared2014: 1 descendant cleared1990200020102020
  1. This deviceK926221 Access Ferritin AssayBio-Rad Laboratories, Inc. · 1993
  2. Descendant · cites it directly · 5 of its ownK970718 Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa)R&D Systems, Inc. · 1997 · Recalled
  3. Descendant · cites it directly · 4 of its ownK090588 Power Processor Sample Processing System with Generic Connection…Beckman Coulter, Inc. · 2009
  4. Descendant · 2 generations on · 3 of its ownK110413 Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc. · 2011 · Recalled
  5. Descendant · 3 generations on · 1 of its ownK140496 Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate…Beckman Coulter, Inc. · 2014 · Recalled
  6. Descendant · 2 generations on · 1 of its ownK080634 Access STFR, Access STFR Calibrators, and Access STFR QC with…Beckman Coulter, Inc. · 2008

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

1997: 11998: 11999: 22005: 12008: 12009: 12011: 12014: 12019: 22024: 2
1997high 2 (1999) · low 0 (2000)2026

Most influential descendants

Showing 5 of 13 · See all
  • K970718Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa)R&D Systems, Inc. · 1997 · cites it directly5descendants
  • K090588Power Processor Sample Processing System with Generic Connection Module, Model: 4210Beckman Coulter, Inc. · 2009 · cites it directly4descendants
  • K110413Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc. · 2011 · 2 generations on3descendants
  • K140496Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access…Beckman Coulter, Inc. · 2014 · 3 generations on1descendant
  • K080634Access STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493, A32494…Beckman Coulter, Inc. · 2008 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K926221Access Ferritin AssayBio-Rad Laboratories, Inc.1993—
+1K970718Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa)R&D Systems, Inc.19973
+1K090588Power Processor Sample Processing System with Generic Connection Module…Beckman Coulter, Inc.2009—
+2K110413Power Processor Sample Processing System with Generic ConnectionsBeckman Coulter, Inc.20112
+3K140496Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access…Beckman Coulter, Inc.20144
+2K080634Access STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493…Beckman Coulter, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199920
200510
200810
200910
201110
201410
201920
202420
FIG. 1 — Lineage of K926221, 1993–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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.

Top candidate predicates for a new JMG device

  1. #1 K234052 Access Ferritinscore 7.3 · 2 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (13)

See all 13

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K970718Quantikine Ivd STFR Enzyme Linked Immunosorbent Assay (Elisa)R&D Systems, Inc.19975
K090588Power Processor Sample Processing System with Generic Connection Module, Model: 4210Beckman Coulter, Inc.20094
K052082Ferritin on the Access Immunoassay Systems, Model 33020Beckman Coulter, Inc.20051
K234052Access FerritinBeckman Coulter, Inc.20240
K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH…Beckman Coulter Biomedical GmbH20190

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

Recalls of this device

DateClassRecallRoot causeReason
Mar 10, 2017Class IIZ-1833-2017OtherBeckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K970718 (R&D Systems, Inc., 1997) has gone furthest, with 5 descendants of its own.

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.

FDA decisions per year · JMG

1in 2024

2024: 1
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

2013: 12025: 1
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

2010: 12013: 122014: 22016: 12017: 12018: 32019: 12020: 42021: 52022: 22023: 132024: 112025: 12
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—01
20110—00
20120—00
20130—112
20140—02
20150—00
20160—01
20170—01
20180—03
20190—01
20200—04
20210—05
20220—02
20230—013
20241—011
20250—112
20260—0—

More from Bio-Rad Laboratories, Inc.

103 FDA decisions under this applicant name. See the company

  • K181661QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemBio-Rad Laboratories, Inc. · 20191 recall
  • K171664Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareBio-Rad Laboratories, Inc. · 2017
  • K161687D-10 Hemoglobin A1c ProgramBio-Rad Laboratories, Inc. · 2016
  • K151321D-100 HbA1c, D-100 HbA1c Calibrator PackBio-Rad Laboratories, Inc. · 2015
  • K142448VARIANT II TURBO HbA1c Kit - 2.0Bio-Rad Laboratories, Inc. · 2015

Recent decisions in JMG

The JMG category page

  • K234052Access FerritinBeckman Coulter, Inc. · 2024
  • K052082Ferritin on the Access Immunoassay Systems, Model 33020Beckman Coulter, Inc. · 20051 recall
  • K964282Tina-Quant Ferritin AssayBoehringer Mannheim Corp. · 1997
  • K971833Elecsys FerritinBoehringer Mannheim Corp. · 1997
  • K963498Ferr Flex Reagent CartridgeDade Chemistry Systems, Inc. · 19973 recalls

https://510kreport.com/device/K926221 · printed Nov 6, 2026

Cite this page

510(k) Report. “K926221: Access Ferritin Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926221

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026