# K003501: N Protein Standard UY Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 15, 2001 after 122 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K041627: Cystatin C Immunoparticles, Control Set, Calibrator (2004), 8 descendants of its own
- 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

Source page: https://510kreport.com/device/K003501
Methodology: https://510kreport.com/methodology