# K072440: Vitros Chemistry Products: CA Slides (Model: 145 0261), Calibrators Kit 1 (Model: 188 2208)

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Sep 20, 2007 after 21 days
- Product code: CJY (Azo Dye, Calcium)
- Device class: 2
- Regulation: 21 CFR 862.1145
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K861386 (1986). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961226: Ektachem Clinical Chemistry Calcium (CA) Slide, Johnson & Johnson Clinical Diagnostics, Inc. (1996) Summary page 3.
- K023876: Vitros Chemistry Products MG Slide, Vitros Chemistry Products Calibrator Kit 1, Ortho-Clinical Diagnostics, Inc. (2002) Summary page 3.

## Most influential descendants
- K190520: VITROS XT Chemistry Products GLU-Ca Slides (2019), 0 descendants of its own

## Recalls of this device
- Jul 9, 2025 · Class II · Z-2335-2025: Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration fai
- Apr 24, 2025 · Class II · Z-1831-2025: transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the
- May 18, 2016 · Class II · Z-2273-2016: Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the VITROS 250/350/950/5,1 FS, 4600 Chemistry System or t
- Jun 12, 2013 · Class II · Z-0302-2014: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

## Indications for use
For in vitro diagnostic use only. VITROS Ca Slides quantitatively measure calcium (Ca) concentration in serum, plasma, and urine. 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 Calibrator Kit 1 is used to calibrate the VITROS Chemistry Systems for the quantitative measurement of BUN/UREA, Ca, CREA, GLU, LAC, Li, Mg, PHOS, SALI, THEO, and URIC.

Source page: https://510kreport.com/device/K072440
Methodology: https://510kreport.com/methodology