# K081875: Gentian Cystatin C Immunoassay

- Pathway: 510(k) (Special)
- Applicant: Gentian AS
- Decided: Aug 20, 2008 after 49 days
- Product code: NDY (Test, Cystatin C)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003503 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071388: Gentian Cystatin C Immunoassay, Gentian AS (2007) Summary page 1.

## Recalls of this device
- Sep 2, 2020 · Class II · Z-0099-2021: 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 Cysta

## Indications for use
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

Source page: https://510kreport.com/device/K081875
Methodology: https://510kreport.com/methodology