510(k) · Cleared
ClearedTina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C Andcystatin C Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · NDY Test, Cystatin C
Cleared on Jun 20, 2008 as substantially equivalent to K041627 (Dako A/S, 2004) after an 88-day review. Its family tree reaches back 2 generations to 1995. 5 later devices descend from it.
- Decided
- Jun 20, 2008
- Review
- 88 days
- Class
- Class II
- Product code
- NDY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953239 (1995). 4 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK953239 Boehringer Mannheim/Hitachi 917 AnalyzerBoehringer Mannheim Corp. · 1995 · Recalled
- 1 generation backK041627 Cystatin C Immunoparticles, Control Set, CalibratorDako A/S · 2004
- This deviceK080811 Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C…Roche Diagnostics Corp. · 2008
- Descendant · cites it directly · 4 of its ownK141143 Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C…Roche Diagnostics · 2014
- Descendant · 2 generations on · 1 of its ownK171072 N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbH · 2017
- Descendant · 2 generations on · 1 of its ownK161817 Tina-quant Cystatin C Gen.2Roche Diagnostics Operations (Rdo) · 2016
- Descendant · 3 generations on · 0 of its ownK242585 Cystatin CSENTINEL CH. SpA · 2025
- Descendant · 3 generations on · 0 of its ownK181082 ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)Siemens Healthcare Diagnostics, Inc. · 2018
Most influential descendants
Showing 5 of 5 · See all- K141143Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C Calibrator, Cystatin C…Roche Diagnostics · 2014 · cites it directly4descendants
- K171072N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbH · 2017 · 2 generations on1descendant
- K161817Tina-quant Cystatin C Gen.2Roche Diagnostics Operations (Rdo) · 2016 · 2 generations on1descendant
- K242585Cystatin CSENTINEL CH. SpA · 2025 · 3 generations on0descendants
- K181082ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)Siemens Healthcare Diagnostics, Inc. · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953239 | Boehringer Mannheim/Hitachi 917 Analyzer | Boehringer Mannheim Corp. | 1995 | 18 |
| −1 | K041627 | Cystatin C Immunoparticles, Control Set, Calibrator | Dako A/S | 2004 | — |
| 0 (this device) | K080811 | Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C Andcystatin… | Roche Diagnostics Corp. | 2008 | — |
| +1 | K141143 | Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C Calibrator… | Roche Diagnostics | 2014 | — |
| +2 | K171072 | N Latex Cystatin C; N Protein Standard UY | Siemens Healthcare Diagnostics Products GmbH | 2017 | — |
| +2 | K161817 | Tina-quant Cystatin C Gen.2 | Roche Diagnostics Operations (Rdo) | 2016 | — |
| +3 | K242585 | Cystatin C | SENTINEL CH. SpA | 2025 | — |
| +3 | K181082 | ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) | Siemens Healthcare Diagnostics, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K041627 | Cystatin C Immunoparticles, Control Set, CalibratorSummary page 2…ial equivalence to the DakoCytomation Cystatin C Device Immunoparticles, Cystatin C Calibrator Kit and Cystatin C Control Set cleared in 510O(k) K041627. Substantial The table below provides a comparison of the predicate device, equivalency - DakoCytomation Cystatin C Immun… | 2004 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141143 | Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C Calibrator, Cystatin C… | 2014 | 4 |
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 13 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K141143 (Roche Diagnostics, 2014) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K041627.
How does its category compare?
All NDY devicesNDY Test, Cystatin C: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
Immunoturbidimetric assay for the quantitative in vitro determination of cystatin C in human serum and lithium-heparin plasma on Roche automated clinical chemistry analyzers. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases.
Cfas (Calibrator for automated systems) Cystatin C is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets.
Cystatin C Control Set is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080811: Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C Andcystatin C Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080811
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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