# K072443: Vitros Chemistry Products CA DT Slides and DT Calibrator Kit and Vitros CA Assay

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Sep 24, 2007 after 25 days
- Product code: CJY (Azo Dye, Calcium)
- Device class: 2
- Regulation: 21 CFR 862.1145
- 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: 2 generations back to K875191 (1988). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870035: Kodak Ektachem DT Slides (CA), Eastman Kodak Company (1987) Summary page 1.
- K071216: Vitros Chemistry Products CRSC Slides, Vitros Chemistry Products DT Calibrator Kit, Model 680 2721, 195 7927, Ortho-Clinical Diagnostics, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- Jul 15, 2014 · Class II · Z-2214-2014: Inability to calibrate or use VITROS NH3 DT Slides, GEN 59 with VITROS Chemistry Products DT Calibrator Kit, Lot 44 when CDM PROM 0168 or 0169 is installed on VITROS DT60/DT60 II Chemistry Systems.

## Indications for use
For in vitro diagnostic use only. VITROS Ca DT Slides quantitatively measure calcium (Ca) concentration in serum and plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone disorders, chronic renal disease and tetany (intermittent muscular contractions or spasms). For in vitro diagnostic use only. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for ALB, ALKP, ALT, AMY, AST, TBIL, NBIL; BUN/CREA, Ca, CHOL, CK, Cl-, C0 2 , CREA, CRSC, Fe, GGT, GLU, HDLC, K 4 , LAC, LDH, LIPA, Mg, Nat, NH-3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems.

Source page: https://510kreport.com/device/K072443
Methodology: https://510kreport.com/methodology