# K141143: Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C Calibrator, Cystatin C Gen.2 Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Jul 17, 2014 after 76 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: 3 generations back to K953239 (1995). 6 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093680: Diazyme Cystatin C Assay, Diazyme Laboratories (2010) Summary page 1.
- K080811: Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C Andcystatin C Control Set, Roche Diagnostics Corp. (2008) Summary page 5.

## Most influential descendants
- K171072: N Latex Cystatin C; N Protein Standard UY (2017), 1 descendant of its own
- K161817: Tina-quant Cystatin C Gen.2 (2016), 1 descendant of its own
- K242585: Cystatin C (2025), 0 descendants of its own
- K181082: ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) (2018), 0 descendants of its own

## Indications for use
The Tina-quant Cystatin C 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. The C.fa.s. (Calibrator for automated systems) Cystatin C is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets. The Cystatin C Control Set Gen.2 is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.

Source page: https://510kreport.com/device/K141143
Methodology: https://510kreport.com/methodology