510(k) · Cleared
Recalled · 2009Abbott Axsym Folate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · CGN Acid, Folic, Radioimmunoassay
Cleared on Jun 24, 1997 after an 8-day review. The FDA summary names its predicate without a number. 2 later devices descend from it. It has been recalled 6 times.
- Decided
- Jun 24, 1997
- Review
- 8 days
- Class
- Class II
- Product code
- CGN
- Recalls
- 6
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972232 | Abbott Axsym Folate | Abbott Laboratories | 1997 | — |
| +1 | K092740 | Architect Folate Reagents, Architect Folate Calibrators, and Architect Folate… | Abbott Laboratories | 2010 | — |
| +2 | K192586 | LIAISON® Folate | DiaSorin, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2020 | 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
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | IMx Folate Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092740 | Architect Folate Reagents, Architect Folate Calibrators, and Architect Folate Controls… | 2010 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 19, 2009 | Not classified | Z-1049-2009 | Employee error | Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument. |
| Apr 23, 2007 | Not classified | Z-1029-2007 | Other | Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument. |
| Dec 16, 2003 | Not classified | Z-0367-04 | Other | The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results. |
| Dec 16, 2003 | Not classified | Z-0366-04 | Other | The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results. |
| Dec 16, 2003 | Not classified | Z-0365-04 | Other | The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results. |
| Dec 16, 2003 | Not classified | Z-0368-04 | Other | The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K092740 (Abbott Laboratories, 2010) has gone furthest, with 1 descendant of its own.
How does its category compare?
All CGN devicesCGN Acid, Folic, Radioimmunoassay: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Abbott AxSYM® Folate is an lon Capture Assay intended to measure the vitamin folic acid in serum, plasma, and red blood cells. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972232: Abbott Axsym Folate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972232
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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