510(k) · Cleared
ClearedTransferrin, Specical Calibrator, Specitrol and Specitrol High Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Electron OY · DDG Transferrin, Antigen, Antiserum, Control
Cleared on Aug 8, 2007 after a 302-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 8, 2007
- Review
- 302 days
- Class
- Class II
- Product code
- DDG
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All DDG devicesDDG Transferrin, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The transferrin test system is intended for the quantitative in-vitro diagnostic determination of transferrin in serum or plasma using T60 Clinical chemistry Analyzers. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, acute infection and iron deficiency anemia. For in vitro diagnostic use on 160 analyzer. SpeciCal protein calibrator is used as a stock calibrator for both quantification of specific proteins in…
Read the full statement (145 words)
The transferrin test system is intended for the quantitative in-vitro diagnostic determination of transferrin in serum or plasma using T60 Clinical chemistry Analyzers. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, acute infection and iron deficiency anemia.
For in vitro diagnostic use on 160 analyzer. SpeciCal protein calibrator is used as a stock calibrator for both quantification of specific proteins in serum and plasma by immunoturbidimetry and for antigen excess detection using methods defined by Thermo Electron Gy
For in vitro diagnostic use on 160 analyzer. Specilrol is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Oy
For in vitro diagnostic use on 160 analyzer. Specitrol High is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Gy
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K063086 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063086: Transferrin, Specical Calibrator, Specitrol and Specitrol High Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063086
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026