510(k) · Cleared
ClearedDimension Vista C3 and C4 Flex Reagent Cartridge, Protein 1 Calibrator, Control Low, Medium, High
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · CZW Complement C3, Antigen, Antiserum, Control
Cleared on Sep 22, 2006 as substantially equivalent to K050665 (Dade Behring, Inc., 2005) and 2 other predicates after an 84-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Sep 22, 2006
- Review
- 84 days
- Class
- Class II
- Product code
- CZW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K002852 (2000). 6 ancestors in all, the oldest K860894 (1986). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002852 | N/T Protein Control SL | Dade Behring, Inc. | 2000 | — |
| −1 | K012468 | Modification to N/T Protein Control SL | Dade Behring, Inc. | 2001 | — |
| 0 (this device) | K061852 | Dimension Vista C3 and C4 Flex Reagent Cartridge, Protein 1 Calibrator… | Dade Behring, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 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? (3)
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 |
|---|---|---|---|
| * | K050665 | N Antisera to Human Complement Factors (C3C, C4)Summary page 2…Dimension Vista TM Protein 1 Control L/M/H (K051087) are substantially equivalent to the Dade Behring N Antisera to Human Complement Factors (C3c, C4) assays (K050665), N Protein Standard SL (KO1 2470) and N/T Protein Control SL (K012468), respectively. The Dimension Vista TM C3 and C4 assa… | 2005 |
| * | K012470 | Modification to N Protein Standard SLSummary page 1…O 66 - 65 Dade Behring N Protein Standard SL - K01 2470 Dade Behring N/T Protein Control SL - K012468 4. Device Description: Dimension VistaTM C3 and… | 2001 |
| * | K012468 | Modification to N/T Protein Control SLSummary page 1…65 Dade Behring N Protein Standard SL - K01 2470 Dade Behring N/T Protein Control SL - K012468 4. Device Description: Dimension VistaTM C3 and C4 Flex® reagent cartridges Proteins contained in hu… | 2001 |
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 6 years and passes through 1 company; a new generation was cleared every 5.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
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.
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?
The C3 method is an in vitro diagnostic test for the quantitative measurement of complement C3 in human serum and heparinized plasma on the Dimension VistaTM System. Measurements of C3 are used as an aid in the diagnosis of immunologic disorders associated with complement C3 protein. The C4 method is an in vitro diagnostic test for the quantitative measurement of complement C4 in human serum and heparinized plasma on the Dimension VistaTM System.…
Read the full statement (173 words)
The C3 method is an in vitro diagnostic test for the quantitative measurement of complement C3 in human serum and heparinized plasma on the Dimension VistaTM System. Measurements of C3 are used as an aid in the diagnosis of immunologic disorders associated with complement C3 protein.
The C4 method is an in vitro diagnostic test for the quantitative measurement of complement C4 in human serum and heparinized plasma on the Dimension VistaTM System. Measurements of C4 are used as an aid in the diagnosis of immunologic disorders associated with complement C4 protein.
Protein 1 Calibrator is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), and Immunoglobulin M (]GM) on the Dimension VistaTM System.
Protein 1 Control L/M/H are for use as an assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of C3 Complement (C3), C4 Complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG) and Immunoglobulin M (IGM) methods on the Dimension VistaTM System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061852 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061852: Dimension Vista C3 and C4 Flex Reagent Cartridge, Protein 1 Calibrator, Control Low, Medium, High.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061852
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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