# K071801: Vitros Chemistry Products CI-Slides, Calibrator Kit 2, Model (S) 844-5207, 166-2659

- Pathway: 510(k) (Special)
- Applicant: Ortho-Clinical Diagnostics, Inc.
- Decided: Jul 20, 2007 after 18 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 K984303 (1999). 3 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K800054: Kodak Ektachem Electrolyte Analyzer, Eastman Kodak Company (1980) Summary page 4.
- K012593: Vitros Chemistry Products Magnetic HDL-Cholesterol Reagent, Vitros Chemistry Products Calibrator Kit 2, Ortho-Clinical Diagnostics, Inc. (2001) Summary page 4.

## Most influential descendants
- K073157: Vitros Chemistry Products K+ Slides and Calibrator Kit 2 (2007), 3 descendants of its own
- 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-0267-2020: Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
- Sep 10, 2019 · Class II · Z-0268-2020: Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
- Jul 11, 2018 · Class III · Z-3043-2018: The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around a triglyce
- Jul 11, 2018 · Class III · Z-3044-2018: The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interference when using serum samples. Triglyceride interference on the Cl- Slide was observed around a triglyce

## Indications for use
For in vitro diagnostic use only. VITROS Cl- Slides quantitatively measure chloride (Cl) concentration in serum and plasma. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. For in vitro diagnostic use only. VITROS Calibrator Kit 2 is used to calibrate the VITROS Chemistry Systems for the quantitative measurement of CHOL, Cl-, ECO2, HDLC, K +, Na +, and TRIG.

Source page: https://510kreport.com/device/K071801
Methodology: https://510kreport.com/methodology