510(k) · Cleared
ClearedAccess Folate Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · CGN Acid, Folic, Radioimmunoassay
Cleared on Aug 23, 2023 as substantially equivalent to K060774 (Beckman Coulter, Inc., 2006) and 1 other predicate after a 265-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Aug 23, 2023
- Review
- 265 days
- Class
- Class II
- Product code
- CGN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K932887 (1993). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK932887 Access Folate AssayBeckman Coulter, Inc. · 1993
- 2 generations backK060774 Folate on the Access Immunoassay Systems, Model A14208Beckman Coulter, Inc. · 2006 · Recalled
- 1 generation backK111952 Access Folate Calibrators on the Access Immunoassay Systems Model…Beckman Coulter, Inc. · 2011 · Recalled
- This deviceK223590 Access Folate AssayBeckman Coulter, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932887 | Access Folate Assay | Beckman Coulter, Inc. | 1993 | — |
| −2 | K060774 | Folate on the Access Immunoassay Systems, Model A14208 | Beckman Coulter, Inc. | 2006 | 1 |
| −1 | K111952 | Access Folate Calibrators on the Access Immunoassay Systems Model A98033 | Beckman Coulter, Inc. | 2011 | 1 |
| 0 (this device) | K223590 | Access Folate Assay | Beckman Coulter, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
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 K233060 Elecsys Folate IIIscore 9.9 · 9 generations · no Class I recall
- #2 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K060774 | Folate on the Access Immunoassay Systems, Model A14208Summary page 4…system Classification Regulation: 21 CFR 862.1295 Classification Product Code: CGN Predicate Device: Device Name: Access Folate Assay 510(k) Numbers: Primary predicate: k060774, Secondary predicate: k111952 Device Description: The Access Folate assay is a paramagnetic particle, chemiluminescent immunoas… | 2006 |
| * | K111952 | Access Folate Calibrators on the Access Immunoassay Systems Model A98033Summary page 4…on: 21 CFR 862.1295 Classification Product Code: CGN Predicate Device: Device Name: Access Folate Assay 510(k) Numbers: Primary predicate: k060774, Secondary predicate: k111952 Device Description: The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative deter… | 2011 |
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 30 years and passes through 1 company; a new generation was cleared every 12.0 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 3 other devices also cite its predicate K060774.
How does its category compare?
All CGN devicesCGN Acid, Folic, Radioimmunoassay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · CGN
1in 2024
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGN
9in 2025
MAUDE reports naming product code CGN, 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 | — | 2 | 26 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 2 | — | 1 | 3 |
| 2010 | 1 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 28 |
| 2012 | 0 | — | 2 | 11 |
| 2013 | 0 | — | 1 | 2 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 1 | — | 2 | 2 |
| 2019 | 0 | — | 3 | 1 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 13 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 1 | — | 0 | 19 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 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, lithium heparin plasma, and red blood cells using the Access Immunoassay Systems.
Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.
Folate levels in serum, lithium heparin plasma, and red blood cells are used to assess folate status. The serum folate levels 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.
https://510kreport.com/device/K223590 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223590: Access Folate Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223590
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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