# K071216: Vitros Chemistry Products CRSC Slides, Vitros Chemistry Products DT Calibrator Kit, Model 680 2721, 195 7927

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: May 25, 2007 after 23 days
- Product code: JFY (Enzymatic Method, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K875191 (1988). 1 ancestor in all.
5 later devices descend from it; 1 cites 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)
- K875191: Kodak Ektachem DT Slides (CRSC), Eastman Kodak Company (1988) Summary page 1.

## Most influential descendants
- K072443: Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and Vitros CA Assay (2007), 4 descendants of its own
- K082099: Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT Calibrator Kit, Models CI-DT Slides:131 4905 (2008), 3 descendants of its own
- K083680: Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator Kit, Model K+DT Slides: 153 2258 (2009), 2 descendants of its own
- K091861: Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator Kit, Model 195 7927 (2009), 1 descendant of its own
- K093611: Vitros Chemistry Products CO2 DT Slides; Vitros Chemmistry Products DT Calibrator Kit, Models CO2 DT Slides, 172 0002; (2010), 0 descendants of its own

## Recalls of this device
- Jan 29, 2014 · Class II · Z-1490-2014: Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Product Code 6802721), GEN 82, on the VITROS DT II System, when using Calibration Data Module (CDM) Rev. 16

## Indications for use
For in vitro diagnostic use only. VITROS Chemistry Products CRSC DT Slides quantitatively measure creatinine concentration in serum and plasma on the DT60/DT60 II analyzer. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl, C02, CREA, CRSC, Fe, GGT, GLU, HIDLC, K+, LAC, LDH, LIPA, Mg, Na+, NIH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

Source page: https://510kreport.com/device/K071216
Methodology: https://510kreport.com/methodology