510(k) · Cleared
Recalled · Class II · 2023Atellica IM Folate Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · CGN Acid, Folic, Radioimmunoassay
Cleared on Apr 12, 2018 as substantially equivalent to K010050 (Bayer Diagnostics Corp., 2001) after a 265-day review. Its family tree reaches back 1 generation to 2001. It has been recalled 3 times.
- Decided
- Apr 12, 2018
- Review
- 265 days
- Class
- Class II
- Product code
- CGN
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010050 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK010050 Advia Centaur and Acs: 180 Folate ImmunoassayBayer Diagnostics Corp. · 2001 · Recalled
- This deviceK172201 Atellica IM Folate AssaySiemens Healthcare Diagnostics, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010050 | Advia Centaur and Acs: 180 Folate Immunoassay | Bayer Diagnostics Corp. | 2001 | 14 |
| 0 (this device) | K172201 | Atellica IM Folate Assay | Siemens Healthcare Diagnostics, Inc. | 2018 | — |
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 |
|---|---|---|---|
| * | K010050 | Advia Centaur and Acs: 180 Folate ImmunoassaySummary page 4…862.1295 4. Predicate Device Information ADVIA Centaur Folate Predicate Device Name: ADVIA Centaur Folate 510(k) Number: K010050 5. Intended Use / Indications for Use Atellica™ IM Folate The Atellica™ IM Folate assay is for in vitro diagnostic use… | 2001 |
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 |
|---|---|---|---|---|
| Jan 9, 2023 | Class II | Z-1151-2023 | Under Investigation by firm | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
| Jan 9, 2023 | Class II | Z-1150-2023 | Under Investigation by firm | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
| Jan 9, 2023 | Class II | Z-1149-2023 | Under Investigation by firm | Negative bias occurred when whole blood calibration (Atellica IM Fol or ADVIA Centaur FolateBA/FolBA) used to test serum samples. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K010050.
How does its category compare?
All CGN devicesCGN Acid, Folic, Radioimmunoassay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Atellica™ Folate assay is for in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the Atellica IM Analyzer. Folic acid measurements are used in the diagnosis and treatment of anemias.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172201: Atellica IM Folate Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172201
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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