# K111664: Diazyme Cystatin C Poc Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Mar 30, 2012 after 290 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 K070734 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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.
- K092911: Smart HBA1C Assay Kit, Model DZ168B-Poc, Smart HBA1C Assay Control Kit, Model DZ168B-Con, Smart HBAC1C Analyzer, Diazyme Laboratories (2010) Summary page 1.

## Indications for use
Diazyme Cystatin C Point-of Care (POC) test reagents are intended for use with the SMART analyzer for the quantitative determination of Cystatin C in venous whole blood by latex enhanced immunoturbidimetric method. The measurement of Cystatin C is used as an aid in the diagnosis and treatment of renal disease. For in vitro Diagnostic Use Only. The Diazyme Cystatin C POC Test Control Kit is intended for use as quality controls for the Cystatin C POC Test. For in vitro Diagnostic Use Only.

Source page: https://510kreport.com/device/K111664
Methodology: https://510kreport.com/methodology