# K162020: VITROS Chemistry Products Cl- Slides

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Clinical Diagnostics
- Decided: Dec 16, 2016 after 148 days
- Product code: CGZ (Electrode, Ion-Specific, Chloride)
- Device class: 2
- Regulation: 21 CFR 862.1170
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K990346 (1999). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990346: Bayer Advia 1650 Chemistry System, Bayer Corp. (1999) Summary page 4.

## Most influential descendants
- K182072: VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides (2018), 1 descendant of its own
- K190520: VITROS XT Chemistry Products GLU-Ca Slides (2019), 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.
- Jul 11, 2018 · Class III · Z-3184-2018: The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantification (LoQ) for urine samples. The measuring range (15-300 mmol/L) for urine samples w

## Indications for use
Rx. For in vitro diagnostic use only. VITROS Chemistry Products Cl- Slides quantitatively measure chloride (Cl-) concentration in serum, plasma, and urine using VITROS Chemistry and Integrated Systems. Chloride measurements are used in diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

Source page: https://510kreport.com/device/K162020
Methodology: https://510kreport.com/methodology