# K161817: Tina-quant Cystatin C Gen.2

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Operations (Rdo)
- Decided: Jul 27, 2016 after 26 days
- Product code: NDY (Test, Cystatin C)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K953239 (1995). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141143: Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C Calibrator, Cystatin C Gen.2 Control Set, Roche Diagnostics (2014) Summary page 5.

## Most influential descendants
- K242585: Cystatin C (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K161817
Methodology: https://510kreport.com/methodology