510(k) · Cleared
Recalled · Class II · 2019Tina-Quant Soluble Transferrin Receptor Test System, Hitachi Catalog # 2148315; Integra Catalog # 2148323
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · DDG Transferrin, Antigen, Antiserum, Control
Cleared on May 1, 2001 after a 211-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 3 times.
- Decided
- May 1, 2001
- Review
- 211 days
- Class
- Class II
- Product code
- DDG
- Recalls
- 3
- Predicates
- 0
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DDG? 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 DDG device
- #1 K240987 Access sTfRscore 8.2 · 3 generations · no Class I recall
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
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 |
|---|---|---|---|---|
| Aug 28, 2019 | Class II | Z-0108-2020 | Under Investigation by firm | Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference |
| Aug 28, 2019 | Class II | Z-0109-2020 | Under Investigation by firm | Tina-quant Soluble Transferrin Receptor (STFR) Assays Updated Claims for Rheumatoid Factors Interference |
| Jun 11, 2008 | Not classified | Z-0009-2009 | Labeling Change Control | Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All DDG devicesDDG Transferrin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DDG
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DDG
114in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DDG
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DDG
1in 2015
MAUDE reports naming product code DDG, 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 | 4 | 114 | 0 | 0 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 2 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K003064 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003064: Tina-Quant Soluble Transferrin Receptor Test System, Hitachi Catalog # 2148315; Integra Catalog # 2148323.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003064
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026