# K091861: Vitros Chemistry Products NA + DT Slides, Model 153 2290 and DT Calibrator Kit, Model 195 7927

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Sep 3, 2009 after 76 days
- Product code: JGS (Electrode, Ion Specific, Sodium)
- Device class: 2
- Regulation: 21 CFR 862.1665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K984303 (1999). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081411: Vitros Chemistry Product NA+ Slides; Vitros Chemistry Products Calibrator Kit 2, Ortho-Clinical Diagnostics, Inc. (2008) Summary page 1.
- K083680: Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator Kit, Model K+DT Slides: 153 2258, Ortho-Clinical Diagnostics, Inc. (2009) Summary page 1.

## Most influential descendants
- 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

## Indications for use
For in vitro diagnostic use only. VITROS Na + DT Slides quantitatively measure sodium (Na +) concentration in serum and plasma. 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. VITROS Chemistry Products DT Calibrator Kit is specially formulated for use as calibrators for the quantitative measurement of ALB, ALKP, ALT, AMYL, AST, TBIL, NBIL, BUN/UREA, Ca, CHOL, CK, Cl-, Co2, CREA, CRSC, Fe, GGT, GLU, HDLC, K+, LAC, LDH, LIPA, Mg, Na+, NH3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K091861
Methodology: https://510kreport.com/methodology