# K063150: Complement C3 and C4, Specical Calibrator and Specitrol Control and High Control

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Electron OY
- Decided: Mar 19, 2007 after 154 days
- Product code: CZW (Complement C3, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K833402 (1984). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033791: Bayer Specific Protein Reference Serum, Bayer Healthcare, LLC (2004) Summary page 2.
- K960824: Immunology Control, Medical Analysis Systems, Inc. (1996) Summary page 2.
- (no number) Bayer Clinical Method for ADVIA 1650 Complement C3 (C3): named in the summary without a submission number
- (no number) Bayer Clinical Method for ADVIA 1650 Complement C4 (C4): named in the summary without a submission number

## Indications for use
Complement C3 is intended for quantitative in-vitro diagnostic determination of the complement C3 concentration in human serum using T60 Clinical Chemistry Analyzers. C3 measurement may aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components. SpeciCal For in vitro diagnostic use on T60 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 Oy SpeciTrol For in vitro diagnostic use on T60 analyzer. SpeciTrol is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Oy Specitrol High For in vitro diagnostic use on T60 analyzer. Specitrol High is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Oy Complement C4 is intended for quantitative in-vitro diagnostic determination of the complement C4 concentration in human serum using T60 Clinical Chemistry Analyzers. C4 measurement may aid in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components. SpeciCal For in vitro diagnostic use on T60 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 Oy SpeciTrol For in vitro diagnostic use on T60 analyzer. SpeciTrol is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Oy Specitrol High For in vitro diagnostic use on T60 analyzer. Specitrol High is intended to be used as an assayed control serum to monitor precision of specific protein tests defined by Thermo Electron Oy

Source page: https://510kreport.com/device/K063150
Methodology: https://510kreport.com/methodology