510(k) · Cleared
ClearedDiazyme Cystatin C Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diazyme Laboratories · NDY Test, Cystatin C
Cleared on Apr 8, 2010 after a 132-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Apr 8, 2010
- Review
- 132 days
- Class
- Class II
- Product code
- NDY
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK093680 Diazyme Cystatin C AssayDiazyme Laboratories · 2010
- 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K093680 | Diazyme Cystatin C Assay | Diazyme Laboratories | 2010 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
2 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?
- Of its descendants, K141143 (Roche Diagnostics, 2014) has gone furthest, with 4 descendants of its own.
How does its category compare?
All NDY devicesNDY Test, Cystatin C: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Diazyme Cystatin C Assay is an in-vitro diagnostic test for the quantitative determination of Cystatin C in serum or plasma by latex enhanced immunoturbidimetric method. The measurement of Cystatin C is used as an aid in the diagnosis and treatment of renal disease.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K093680 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093680: Diazyme Cystatin C Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093680
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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