510(k) · Cleared
ClearedComplement C3 and C4, Specical Calibrator and Specitrol Control and High Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Electron OY · CZW Complement C3, Antigen, Antiserum, Control
Cleared on Mar 19, 2007 as substantially equivalent to K033791 (Bayer Healthcare, LLC, 2004) and 1 other predicate after a 154-day review. Its family tree reaches back 2 generations to 1984.
- Decided
- Mar 19, 2007
- Review
- 154 days
- Class
- Class II
- Product code
- CZW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K833402 (1984). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK833402 Tech. RA-1000SYS-Analytes ImmunoglobulinTechnicon Instruments Corp. · 1984
- 1 generation backK033791 Bayer Specific Protein Reference SerumBayer Healthcare, LLC · 2004
- This deviceK063150 Complement C3 and C4, Specical Calibrator and Specitrol Control and…Thermo Electron OY · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K833402 | Tech. RA-1000SYS-Analytes Immunoglobulin | Technicon Instruments Corp. | 1984 | — |
| −1 | K033791 | Bayer Specific Protein Reference Serum | Bayer Healthcare, LLC | 2004 | — |
| 0 (this device) | K063150 | Complement C3 and C4, Specical Calibrator and Specitrol Control and High Control | Thermo Electron OY | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
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 CZW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K033791 | Bayer Specific Protein Reference SerumSummary page 2…ent C4 (C4) Predicate device for the Specical calibrator: Liquid Specific Protein Calibrator, Bayer USA, k033791. Predicate devices for the Specitrol and Specitrol High controls:… | 2004 |
| * | K960824 | Immunology ControlSummary page 2…trol and Specitrol High controls: Liquid Assayed Immunology Controls I and 3, Medical Analysis Systems USA, k960824. G. Substantial equivalence -similarities Complement C3 is substantia… | 1996 |
| * | — | Bayer Clinical Method for ADVIA 1650 Complement C3 (C3) Named without a submission number | |
| * | — | Bayer Clinical Method for ADVIA 1650 Complement C4 (C4) Named without a submission number |
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?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 20.1 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All CZW devicesCZW Complement C3, 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 · CZW
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · CZW
Too few CZW 510(k)s in any year since 2007 to give a median.
Recalls per year · CZW
No recall names CZW since 2007.
Adverse event reports per year · CZW
2in 2024
MAUDE reports naming product code CZW, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (296 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063150 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063150: Complement C3 and C4, Specical Calibrator and Specitrol Control and High Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063150
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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