510(k) · Cleared
ClearedAia-Pack RBC Folate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tosoh Bioscience, Inc. · CGN Acid, Folic, Radioimmunoassay
Cleared on Oct 2, 2009 as substantially equivalent to K010050 (Bayer Diagnostics Corp., 2001) after a 149-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Oct 2, 2009
- Review
- 149 days
- Class
- Class II
- Product code
- CGN
- Recalls
- None
- 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 deviceK091332 Aia-Pack RBC FolateTosoh Bioscience, Inc. · 2009
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) | K091332 | Aia-Pack RBC Folate | Tosoh Bioscience, Inc. | 2009 | — |
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 2…ication Name: Class II CGN 21 CFR 862.1295 Folic Acid Test System Predicate Device: K010050, ADVIA Centaur and ACS: 180 Folate Immunoassay, Manufactured by Bayer Diagnostics… | 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)
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.
- 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. 2009, 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?
Tosoh AIA-PACK RBC FOLATE is designed for in vitro diagnostic use only for the quantitative measurement of red blood cell folate (RBC FOLATE) in whole blood (Heparin or EDTA) samples on TOSOH AIA system analyzer. Measurement of RBC Folate is used in the diagnosis and treatment of 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/K091332 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091332: Aia-Pack RBC Folate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091332
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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