510(k) · Cleared
ClearedArchitect Folate Reagents, Architect Folate Calibrators, and Architect Folate Controls, Models 1P74, 1P74, 1P74
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 Mar 5, 2010 as substantially equivalent to K972232 (Abbott Laboratories, 1997) after a 178-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- Mar 5, 2010
- Review
- 178 days
- Class
- Class II
- Product code
- CGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972232 (1997). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K192586LIAISON® FolateDiaSorin, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972232 | Abbott Axsym Folate | Abbott Laboratories | 1997 | 6 |
| 0 (this device) | K092740 | Architect Folate Reagents, Architect Folate Calibrators, and Architect Folate… | Abbott Laboratories | 2010 | — |
| +1 | K192586 | LIAISON® Folate | DiaSorin, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K972232 | Abbott Axsym FolateSummary page 2…sification Panel: Clinical Chemistry Product Code: JJX Legally marketed device to which equivalency is claimed: Reagents predicate: AxSYM Folate (K972232) Calibrators predicate: AxSYM Folate (K972232) Controls predicate: AxSYM Fol ate (K972232) Intended Use o… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192586 | LIAISON® Folate | 2020 | 0 |
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?
- Its one ancestor has a recall.
- Of its descendants, K192586 (DiaSorin, Inc., 2020) has gone furthest, with 0 descendants 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. 2010, 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 ARCHITECT Folate assay is a chemiluminescent microparticle Folate Binding
Protein assay for the quantitative determination of folate in human serum and
plasma on the ARCHITECT i System. Folate measurements are used in the
diagnosis and treatment of megaloblastic anemia.
The ARCHITECT Folate Calibrators are for the calibration of the ARCHITECT
iSystem when used for the quantitative determination of folate in human serum
and plasma.
The ARCHITECT Folate Controls are for the verification of the accuracy and
precision of the ARCHITECT i System when used for the quantitative
determination of folate in human serum and plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092740 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092740: Architect Folate Reagents, Architect Folate Calibrators, and Architect Folate Controls, Models 1P74, 1P74, 1P74.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092740
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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