510(k) · Cleared
ClearedDimension Vista Cysc Flex Reagent Cartridge, Protein 3 Calibrator and Cystatin Control Low and High
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · NDY Test, Cystatin C
Cleared on Jan 22, 2007 as substantially equivalent to K041878 (Dade Behring, Inc., 2004) and 1 other predicate after a 77-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Jan 22, 2007
- Review
- 77 days
- Class
- Class II
- Product code
- NDY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K003503 (2001). 3 ancestors in all. 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 | K003503 | N Latex Cystatin C | Dade Behring, Inc. | 2001 | — |
| −1 | K041878 | N Latex Cystatin | Dade Behring, Inc. | 2004 | — |
| 0 (this device) | K063351 | Dimension Vista Cysc Flex Reagent Cartridge, Protein 3 Calibrator and Cystatin… | Dade Behring, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 NDY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NDY device
- #1 K242585 Cystatin Cscore 10.5 · 5 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K041878 | N Latex CystatinSummary page 1…X; JJY Panel: Clinical Chemistry (75) 3. Identification of the Legally Marketed Device: Dade Behring N Latex Cystatin C Kit- K041878 Dade Behring N Protein Standard UY - K003501… | 2004 |
| * | K003501 | N Protein Standard UY CalibratorSummary page 1…stry (75) 3. Identification of the Legally Marketed Device: Dade Behring N Latex Cystatin C Kit- K041878 Dade Behring N Protein Standard UY - K003501 (10009 3: Dade Be… | 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 3.4 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K041878.
How does its category compare?
All NDY devicesNDY Test, Cystatin C: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · NDY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDY
265in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NDY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDY
10in 2025
MAUDE reports naming product code NDY, 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 | 3 | 95 | 0 | 0 |
| 2008 | 6 | 101 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 265 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 1 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CYSC method is an in vitro diagnostic test for the quantitative determination of cystatin C in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Cystatin C measurements are used in the diagnosis and treatment of renal diseases.
The PROT3 CAL is an in vitro diagnostic product for the calibration of the Cystatin C (CYSC) and Microalbumin (MALB) methods on the Dimension Vista® System.
CYSC CON L and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in determination of cystatin C (CYSC) on the Dimension Vista® System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063351: Dimension Vista Cysc Flex Reagent Cartridge, Protein 3 Calibrator and Cystatin Control Low and High.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063351
Report an extraction error
Are you the manufacturer?
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