# K001310: Vitros Chemistry  Products Crea Slide, Virtros Chemistry Products Calibrator Kit 1

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: May 5, 2000 after 10 days
- Product code: JFY (Enzymatic Method, Creatinine)
- 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K063591: Vitros Chemistry Products Crea Slides,Model# 6802584, Vitros Chemistry Products Calibrator Kit 1,Model#1882208 (2006), 2 descendants of its own
- K182063: VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System (2018), 1 descendant of its own
- K190326: VITROS XT Chemistry Products UREA-CREA Slides (2019), 0 descendants of its own

Source page: https://510kreport.com/device/K001310
Methodology: https://510kreport.com/methodology