510(k) · Cleared
ClearedTina-quant Cystatin C Gen.2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Operations (Rdo) · NDY Test, Cystatin C
Cleared on Jul 27, 2016 as substantially equivalent to K141143 (Roche Diagnostics, 2014) after a 26-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Jul 27, 2016
- Review
- 26 days
- Class
- Class II
- Product code
- NDY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K953239 (1995). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK953239 Boehringer Mannheim/Hitachi 917 AnalyzerBoehringer Mannheim Corp. · 1995 · Recalled
- 3 generations backK041627 Cystatin C Immunoparticles, Control Set, CalibratorDako A/S · 2004
- 2 generations backK080811 Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C…Roche Diagnostics Corp. · 2008
- 1 generation backK141143 Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C…Roche Diagnostics · 2014
- This deviceK161817 Tina-quant Cystatin C Gen.2Roche Diagnostics Operations (Rdo) · 2016
- Descendant · cites it directly · 0 of its ownK242585 Cystatin CSENTINEL CH. SpA · 2025
Most influential descendants
Showing 1 of 1 · See all- K242585Cystatin CSENTINEL CH. SpA · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953239 | Boehringer Mannheim/Hitachi 917 Analyzer | Boehringer Mannheim Corp. | 1995 | 18 |
| −3 | K041627 | Cystatin C Immunoparticles, Control Set, Calibrator | Dako A/S | 2004 | — |
| −2 | 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 | — |
| 0 (this device) | K161817 | Tina-quant Cystatin C Gen.2 | Roche Diagnostics Operations (Rdo) | 2016 | — |
| +1 | K242585 | Cystatin C | SENTINEL CH. SpA | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K141143 | Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C Calibrator, Cystatin C…Summary page 5…predicate device. The Predicate Devices device name, Tina-quant Cystatin C Gen.2, is unchanged from how it was cleared in 510(k) K141143 For the Tina-quant Cystatin C Gen.2, the establishment registration num… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242585 | Cystatin C | 2025 | 0 |
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 21 years and passes through 5 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K242585 (SENTINEL CH. SpA, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K141143.
How does its category compare?
All NDY devicesNDY Test, Cystatin C: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Tina-quant Cystatin Gen.2 is an in vitro test for the quantitative determination of cystatin C in human serum and plasma on Roche/Hitachi cobas c systems. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161817 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161817: Tina-quant Cystatin C Gen.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161817
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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