# K081411: Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products Calibrator Kit 2

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Jun 30, 2008 after 41 days
- Product code: JGS (Electrode, Ion Specific, Sodium)
- Device class: 2
- Regulation: 21 CFR 862.1665
- 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: 4 generations back to K984303 (1999). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961099: Ektachem Clinical Chemistry Slide Sodium (NA+), Johnson & Johnson Clinical Diagnostics, Inc. (1996) Summary page 1.
- K073157: Vitros Chemistry Products K+ Slides and Calibrator Kit 2, Ortho-Clinical Diagnostics, Inc. (2007) Summary page 1.

## Most influential descendants
- 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 22, 2019 · Class II · Z-0992-2019: Imprecision in the affected lot may produce negatively or positively biased patient sample and quality control fluid results.
- Dec 20, 2016 · Class II · Z-1117-2017: There is a potential for biased results to be generated over the 10 day on-analyzer storage limit when using VITROS Na+ Slide cartridges warmed at room temperature and loaded onto the analyzer after u
- Oct 17, 2013 · Class II · Z-1088-2014: Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results.
- Oct 17, 2013 · Class II · Z-1087-2014: Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator Kit 2 due to false positive serum and plasma sample results.

## Indications for use
For in vitro diagnostic use only. VITROS Na + Slides quantitatively measure sodium (Na +) concentration in serum, plasma, and urine. Measurements used by this device are used in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other disease involving electrolyte imbalance. For in vitro diagnostic use only. VITROS Calibrator Kit 2 is used to calibrate the VITROS Chemistry Systems for the quantitative measurement of CHOL, CY, ECO2, HDLC, K +, Na +, and TRIG.

Source page: https://510kreport.com/device/K081411
Methodology: https://510kreport.com/methodology