# K093680: Diazyme Cystatin C Assay

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Apr 8, 2010 after 132 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.
6 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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
The Diazyme Cystatin C Assay is an in-vitro diagnostic test for the quantitative determination of Cystatin C in serum or plasma by latex enhanced immunoturbidimetric method. The measurement of Cystatin C is used as an aid in the diagnosis and treatment of renal disease.

Source page: https://510kreport.com/device/K093680
Methodology: https://510kreport.com/methodology