# K093137: K-Assay Cystatin C Reagent, Calibrator and Control

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: Sep 28, 2010 after 358 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The K-ASSAY® Cystatin C Assay is for the quantitative determination of human cystatin C in serum, EDTA plasma, or lithium heparin plasma by immunoturbidimetric assay. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases. FOR IN VITRO DIAGNOSTIC USE. The K-ASSAY® Cystatin C Calibrator is intended to be used for the calibration of the K-ASSAY® Cystatin C Assay. FOR IN VITRO DIAGNOSTIC USE. The K-ASSAY® Cystatin C Control is intended for use as an assayed quality control material for monitoring the performance of cystatin C assays.

Source page: https://510kreport.com/device/K093137
Methodology: https://510kreport.com/methodology