# K063086: Transferrin, Specical Calibrator, Specitrol and Specitrol High Controls

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Electron OY
- Decided: Aug 8, 2007 after 302 days
- Product code: DDG (Transferrin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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

Source page: https://510kreport.com/device/K063086
Methodology: https://510kreport.com/methodology