# K083680: Vitros Chemistry Products K+DT Slides: Vitros Chemistry Products DT Calibrator Kit, Model K+DT Slides: 153 2258

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Feb 27, 2009 after 77 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: 4 generations back to K875191 (1988). 6 ancestors in all.
2 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)
- K912844: Kodak Ektachem Dtii System, Eastman Kodak Company (1991) Summary page 4.
- K082099: Vitros Chemistry Products CI-DT Slides; Vitros Chemistry Products DT Calibrator Kit, Models CI-DT Slides:131 4905, Ortho-Clinical Diagnostics, Inc. (2008) Summary page 4.

## 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
- May 9, 2013 · Class III · Z-1614-2013: While performing interval testing, Ortho Clinical Diagnostics (OCD) determined that a surfactant was unintentionally added to VITROS Chemistry Products K+ Slides during the manufacturing process.

## Indications for use
VITROS Chemistry Products K + DT Slides quantitatively measure potassium (K +) concentration in serum and plasma using VITROS.DT60 and DT60 II Chemistry Systems. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases or conditions characterized by low or high blood potassium levels. For in vitro diagnostic use only. 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+, NI-3, PHOS, TP, TRIG, urCR, and URIC on VITROS DT Chemistry Systems. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K083680
Methodology: https://510kreport.com/methodology