510(k) · Cleared
Recalled · 2003Abbott Architect 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 Dec 16, 2002 after a 68-day review. The FDA summary names its predicate without a number. It has been recalled 4 times.
- Decided
- Dec 16, 2002
- Review
- 68 days
- Class
- Class II
- Product code
- CGN
- Recalls
- 4
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | Bio-Rad Quantaphase II B12/Folate Radioassay Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 16, 2003 | Not classified | Z-0361-04 | 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-0362-04 | 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-0364-04 | 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-0363-04 | 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. |
No ancestor or descendant has a Class I recall.
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?
The ARCHITECT® Folate assay is a Chemiluminescent Microparticle Folate Binding Protein assay used for the quantitative determination of folate in human serum, plasma, and red blood cells on the ARCHITECT i System. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023397 · printed Nov 3, 2026
Cite this page
510(k) Report. “K023397: Abbott Architect Folate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K023397
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026