510(k) · Cleared
ClearedDimension Vista; Cer Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control Medium, Protein 1 Control High
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · CHN Immunochemical, Ceruloplasmin
Cleared on Feb 15, 2007 as substantially equivalent to K053074 (Dade Behring, Inc., 2006) and 2 other predicates after a 69-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Feb 15, 2007
- Review
- 69 days
- Class
- Class II
- Product code
- CHN
- 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) | K063655 | Dimension Vista; Cer Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1… | Dade Behring, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 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 CHN? 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 |
|---|---|---|---|
| * | K053074 | N Antisera to Human CeruloplasminSummary page 1…Immunology (82) and Clinical Chemistry (75) 3. Identification of the Legally Marketed Devices: Dade Behring NAntisera to Human Ceruloplasmin- K053074 Dade Behring N Protein Standard SI - K01 2470 Dade Behring N/T Protein Control SL - K012468… | 2006 |
| * | K012470 | Modification to N Protein Standard SLSummary page 1…3. Identification of the Legally Marketed Devices: Dade Behring NAntisera to Human Ceruloplasmin- K053074 Dade Behring N Protein Standard SI - K01 2470 Dade Behring N/T Protein Control SL - K012468… | 2001 |
| * | K012468 | Modification to N/T Protein Control SLSummary page 1…Dade Behring NAntisera to Human Ceruloplasmin- K053074 Dade Behring N Protein Standard SI - K01 2470 Dade Behring N/T Protein Control SL - K012468 oouubSs Dade Behri… | 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 7 years and passes through 1 company; a new generation was cleared every 5.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K053074.
How does its category compare?
All CHN devicesCHN Immunochemical, Ceruloplasmin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · CHN
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · CHN
Too few CHN 510(k)s in any year since 2007 to give a median.
Recalls per year · CHN
6in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHN
1in 2020
MAUDE reports naming product code CHN, 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 | 2 | — | 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 | — | 6 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CER method is an in vitro diagnostic test for the quantitative determination of Ceruloplasmin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders. PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Immunoglobulin A (IGA), Immunoglobulin G (IGG), lmmunogpobulin…
Read the full statement (125 words)
The CER method is an in vitro diagnostic test for the quantitative determination of Ceruloplasmin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.
PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Ceruloplasmin (CER), Immunoglobulin A (IGA), Immunoglobulin G (IGG), lmmunogpobulin M (IGM) and Prealbumin (PREALB) methods on the Dimension Vista System.
PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), ceruloplasmin (CER), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM) and prealbumin (PREALB) on the Dimension Vista® System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063655 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063655: Dimension Vista; Cer Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control Medium, Protein 1 Control High.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063655
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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