# K073157: Vitros Chemistry Products K+ Slides and Calibrator Kit 2

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Dec 7, 2007 after 29 days
- Product code: CEM (Electrode, Ion Specific, Potassium)
- Device class: 2
- Regulation: 21 CFR 862.1600
- 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: 3 generations back to K984303 (1999). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961115: Ektachem Clinical Chemistry Slide Potassium (K+), Johnson & Johnson Clinical Diagnostics, Inc. (1996) Summary page 1.
- K071801: Vitros Chemistry Products CI-Slides, Calibrator Kit 2, Model (S) 844-5207, 166-2659, Ortho-Clinical Diagnostics, Inc. (2007) Summary page 1.

## Most influential descendants
- K081411: Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products Calibrator Kit 2 (2008), 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
- Sep 10, 2019 · Class II · Z-0269-2020: Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.

## Indications for use
For in vitro diagnostic use only. VITROS K+ Slides quantitatively measure potassium (K + ) concentration in serum, plasma, and urine. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases and conditions characterized by low or high blood potassium levels. For in vitro diagnostic use only. VITROS Calibrator Kit 2 is used to calibrate the VITROS Chemistry Systems for the quantitative measurement of CHOL, Ci, ECO2, HIDLC, K*, Nat, and TRIG.

Source page: https://510kreport.com/device/K073157
Methodology: https://510kreport.com/methodology