510(k) · Cleared
ClearedN Latex Cystatin
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 Aug 16, 2004 as substantially equivalent to K003503 (Dade Behring, Inc., 2001) after a 35-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- Aug 16, 2004
- Review
- 35 days
- Class
- Class II
- Product code
- NDY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003503 (2001). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK003503 N Latex Cystatin CDade Behring, Inc. · 2001
- This deviceK041878 N Latex CystatinDade Behring, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK083906 Advia Chemistry Cystatin C Reagent, Advia Chemistry Cystatin C…Siemens Healthcare Diagnostics · 2009
- Descendant · cites it directly · 0 of its ownK080662 Genzyme Cystatin C Reagent Anf Genzyme Cystatin C CalibratorGenzyme Corporation · 2008
- Descendant · cites it directly · 0 of its ownK063351 Dimension Vista Cysc Flex Reagent Cartridge, Protein 3 Calibrator…Dade Behring, Inc. · 2007
Most influential descendants
Showing 3 of 3 · See all- K083906Advia Chemistry Cystatin C Reagent, Advia Chemistry Cystatin C Calibrator, Models P/N…Siemens Healthcare Diagnostics · 2009 · cites it directly0descendants
- K080662Genzyme Cystatin C Reagent Anf Genzyme Cystatin C CalibratorGenzyme Corporation · 2008 · cites it directly0descendants
- K063351Dimension Vista Cysc Flex Reagent Cartridge, Protein 3 Calibrator and Cystatin Control…Dade Behring, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003503 | N Latex Cystatin C | Dade Behring, Inc. | 2001 | — |
| 0 (this device) | K041878 | N Latex Cystatin | Dade Behring, Inc. | 2004 | — |
| +1 | K083906 | Advia Chemistry Cystatin C Reagent, Advia Chemistry Cystatin C Calibrator… | Siemens Healthcare Diagnostics | 2009 | — |
| +1 | K080662 | Genzyme Cystatin C Reagent Anf Genzyme Cystatin C Calibrator | Genzyme Corporation | 2008 | — |
| +1 | K063351 | Dimension Vista Cysc Flex Reagent Cartridge, Protein 3 Calibrator and Cystatin… | Dade Behring, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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? (1)
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 |
|---|---|---|---|
| * | K003503 | N Latex Cystatin CSummary page 1…Clinical Chemistry Product Code: NDY 3. Identification of the Legally Marketed Device: N Latex Cystatin C - K003503 4. Device Description: Polystyrene particles coated with specific antibodies to human cystatin C are aggregat… | 2001 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All NDY devicesNDY Test, Cystatin C: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
N Latex Cystatin C is an in vitro diagnostics kit containing reagents for the quantitative determination of cystatin C in human serum and heparinized plasma by means of particle-enhanced immunonephelometry using BNTM Systems. Cystatin C measurements are used in the diagnosis and treatment of renal diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041878: N Latex Cystatin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041878
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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