510(k) · Cleared
Recalled · Class II · 2020Gentian Cystatin C Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gentian AS · NDY Test, Cystatin C
Cleared on Aug 20, 2008 as substantially equivalent to K071388 (Gentian AS, 2007) after a 49-day review. Its family tree reaches back 2 generations to 2001. It has been recalled once.
- Decided
- Aug 20, 2008
- Review
- 49 days
- Class
- Class II
- Product code
- NDY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003503 (2001). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 10.6 · 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 |
|---|---|---|---|
| * | K071388 | Gentian Cystatin C ImmunoassaySummary page 1…lterTm Synchron® and UniCel®O Systems is substantially equivalent to the Gentian Cystatin C Immunoassay on the Abbott Architect® cSOOO instrument (K071388), with respect to indications for use, device design and material. The difference between the Synchron and UniCel… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 2, 2020 | Class II | Z-0099-2021 | Under Investigation by firm | The firm has identified lots of calibrators that have shown to measure incorrect high values over time compared to the assigned values when released for distribution. This could result in higher Cystatin C values measured in patients. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 6.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
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?
Gentian Cystatin C Immunoassay is an in-vitro diagnostic test for quantitative determination of cystatin c in human serum and plasma. The measurement of cystatin c is used in the diagnosis and treatment of renal diseases. The instruments that can be used with the assay are:
The Beckman CoulterTM Synchron® and UniCel® Systems
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081875 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081875: Gentian Cystatin C Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081875
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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