# K071388: Gentian Cystatin C Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Gentian AS
- Decided: Nov 6, 2007 after 172 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: 1 generation back to K003503 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003503: N Latex Cystatin C, Dade Behring, Inc. (2001) Summary page 1.

## Most influential descendants
- K081875: Gentian Cystatin C Immunoassay (2008), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K071388
Methodology: https://510kreport.com/methodology