510(k) Report

510(k) · Cleared

Recalled · Class II · 2012

Folate on the Access Immunoassay Systems, Model A14208

K060774510(k) SpecialCleared Apr 21, 200630-day reviewClass II21 CFR 862.1295Recalls 1

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

Beckman Coulter, Inc. · CGN Acid, Folic, Radioimmunoassay

Cleared on Apr 21, 2006 as substantially equivalent to K932887 (Beckman Coulter, Inc., 1993) and 2 other predicates after a 30-day review. Its family tree reaches back 1 generation to 1993. 7 later devices descend from it. It has been recalled once.

Decided
Apr 21, 2006
Review
30 days
Class
Class II
Product code
CGN
Recalls
1
Predicates
3

Its longest line of descent runs back 1 generation to K932887 (1993). 3 ancestors in all. 7 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1994: 1 other ancestor2019: 2 descendants cleared2011: 2 descendants cleared2009: 1 descendant cleared2023: 1 descendant cleared2014: 1 descendant clearedK932887 · Access Folate Assay · Beckman Coulter, Inc. · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant K932887 · Access Folate Assay · Beckman Coulter, Inc. · 19930
  1. Root · 1 generation backK932887 Access Folate AssayBeckman Coulter, Inc. · 1993
  2. This deviceK060774 Folate on the Access Immunoassay Systems, Model A14208Beckman Coulter, Inc. · 2006
  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 · cites it directly · 1 of its ownK111952 Access Folate Calibrators on the Access Immunoassay Systems Model…Beckman Coulter, Inc. · 2011 · Recalled
  7. Descendant · cites it directly · 0 of its ownK223590 Access Folate AssayBeckman Coulter, Inc. · 2023

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2009: 12011: 22014: 12019: 22023: 1
2009high 2 (2011) · low 0 (2010)2026

Most influential descendants

Showing 5 of 7 · See all
  • 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
  • K111952Access Folate Calibrators on the Access Immunoassay Systems Model A98033Beckman Coulter, Inc. · 2011 · cites it directly1descendant
  • K223590Access Folate AssayBeckman Coulter, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K932887Access Folate AssayBeckman Coulter, Inc.1993—
0 (this device)K060774Folate on the Access Immunoassay Systems, Model A14208Beckman Coulter, Inc.2006—
+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
+1K111952Access Folate Calibrators on the Access Immunoassay Systems Model A98033Beckman Coulter, Inc.20111
+1K223590Access Folate AssayBeckman Coulter, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201120
201410
201920
202310
FIG. 1 — Lineage of K060774, 1993–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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 CGN? 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 CGN device

  1. #1 K233060 Elecsys Folate IIIscore 9.9 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K932887Access Folate Assay
Summary page 1
…tem Classification Name: Folic Acid test system Predicate Device Access Folate Assay Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 510(k) Numbers: k932887, k943149, k955434 Device Description The Access Folate reagents, Access Folate Calibrators, Access Folate Lysing Agent, Folate…
Beckman Coulter, Inc.1993—
*K943149Access Red Blood Cell Folate Assay
Summary page 1
…sification Name: Folic Acid test system Predicate Device Access Folate Assay Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 510(k) Numbers: k932887, k943149, k955434 Device Description The Access Folate reagents, Access Folate Calibrators, Access Folate Lysing Agent, Folate Calibrato…
Beckman Coulter, Inc.1994—
*K955434Access Folate Assay (Modification)
Summary page 1
…n Name: Folic Acid test system Predicate Device Access Folate Assay Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 510(k) Numbers: k932887, k943149, k955434 Device Description The Access Folate reagents, Access Folate Calibrators, Access Folate Lysing Agent, Folate Calibrator SO and…
Beckman Coulter, Inc.1996—

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K090588Power Processor Sample Processing System with Generic Connection Module, Model: 4210Beckman Coulter, Inc.20094
K111952Access Folate Calibrators on the Access Immunoassay Systems Model A98033Beckman Coulter, Inc.20111
K223590Access Folate AssayBeckman Coulter, Inc.20230
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
Jul 24, 2012Class IIZ-0046-2013Nonconforming Material/ComponentBeckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K090588 (Beckman Coulter, Inc., 2009) has gone furthest, with 4 descendants of its own.

How does its category compare?

All CGN devices

CGN Acid, Folic, Radioimmunoassay: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CGN

1in 2024

2009: 22010: 12011: 12014: 12016: 12018: 12020: 12023: 12024: 1
2007high 2 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CGN

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

Recalls per year · CGN

3in 2019

2007: 22008: 12009: 12010: 12012: 22013: 12018: 22019: 3
2007high 3 (2019) · low 0 (2011)2026

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

Adverse event reports per year · CGN

9in 2025

2007: 262009: 32011: 282012: 112013: 22014: 42015: 12016: 42017: 62018: 22019: 12020: 52021: 32022: 132023: 82024: 192025: 9
2007high 28 (2011) · low 0 (2008)2025

MAUDE reports naming product code CGN, 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—226
20080—10
20092—13
20101—10
20111—028
20120—211
20130—12
20141—04
20150—01
20161—04
20170—06
20181—22
20190—31
20201—05
20210—03
20220—013
20231—08
20241—019
20250—09
20260—0—

What is it indicated for?

The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay Systems.

Folate levels in both serum and red blood cells are used to assess folate status. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency.

Indications for use as stated in the FDA summary.

More from Beckman Coulter, Inc.

456 FDA decisions under this applicant name. See the company

  • K262597Access BNP IIBeckman Coulter, Inc. · 2026
  • K261109Access MeMed BVBeckman Coulter, Inc. · 2026
  • K262109Access NT-proBNPBeckman Coulter, Inc. · 2026
  • K252169Access BNP IIBeckman Coulter, Inc. · 2026
  • K254059Access anti-HBc IgMBeckman Coulter, Inc. · 2026

Recent decisions in CGN

The CGN category page

  • K233060Elecsys Folate IIIRoche Diagnostics · 2024
  • K223590Access Folate AssayBeckman Coulter, Inc. · 2023
  • K192586LIAISON® FolateDiaSorin, Inc. · 2020
  • K172201Atellica IM Folate AssaySiemens Healthcare Diagnostics, Inc. · 20183 recalls
  • K161646Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control SetDiazyme Laboratories · 2016

https://510kreport.com/device/K060774 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060774: Folate on the Access Immunoassay Systems, Model A14208.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060774

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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