# K080811: Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C Andcystatin C Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Jun 20, 2008 after 88 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: 2 generations back to K953239 (1995). 4 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041627: Cystatin C Immunoparticles, Control Set, Calibrator, Dako A/S (2004) Summary page 2.

## Most influential descendants
- K141143: Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C Calibrator, Cystatin C Gen.2 Control Set (2014), 4 descendants of its own
- 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
Immunoturbidimetric assay for the quantitative in vitro determination of cystatin C in human serum and lithium-heparin plasma on Roche automated clinical chemistry analyzers. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases. Cfas (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. Cystatin C Control Set 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/K080811
Methodology: https://510kreport.com/methodology