# K041627: Cystatin C Immunoparticles, Control Set, Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dako A/S
- Decided: Sep 3, 2004 after 79 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: 1 generation back to K953239 (1995). 3 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 12 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.
- K953239: Boehringer Mannheim/Hitachi 917 Analyzer, Boehringer Mannheim Corp. (1995) Summary page 1.
- K003501: N Protein Standard UY Calibrator, Dade Behring, Inc. (2001) Summary page 1.

## Most influential descendants
- K080811: Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C Andcystatin C Control Set (2008), 5 descendants of its own
- 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

## Indications for use
For In Vitro Diagnostic Use. For Professional Use Only. Cystatin C Immunoparticles are intended for the quantitative determination of cystatin C in human serum, heparinized plasma and EDTA plasma by turbidimetry and nephelometry. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases. For In Vitro Diagnostic Use. For Professional Use Only. Cystatin C Control Set is an assayed bi-level control intended to monitor and evaluate the precision and accuracy of the quantitative immunological determination of human cystatin C by turbidimetry or nephelometry. For In Vitro Diagnostic Use. For Professional Use Only. Cystatin C Calibrator is intended for establishing calibration curves for the quantitative immunological determination of human cystatin C by turbidimetry or nephelometry.

Source page: https://510kreport.com/device/K041627
Methodology: https://510kreport.com/methodology