# K970330: Dade Indirect Imt System with TCO2 Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Dade Intl., Inc.
- Decided: Apr 14, 1997 after 76 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
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K960697: Ultracid and Ultracid F Disinfecting Solution, Ultradent Products, Inc. (1996). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K051087: Dimension Vista Integrated System (2005), 5 descendants of its own
- K073561: Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator (2008), 1 descendant of its own
- K061838: Dimension Vista Chemistry 1 Calibrator, Model KC110 (2006), 1 descendant of its own
- K143720: Dimension Vista MMB Assay (2015), 0 descendants of its own
- K140790: Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) (2015), 0 descendants of its own

## Recalls of this device
- Feb 24, 2015 · Class II · Z-1398-2015: A positive bias beyond 5% resulting in a dilution check failure or an unnecessary dilution check correction if the positive bias is greater than 1% and less than 5%. The dilution check correction woul

## Indications for use
Both systems use integrated multisensor technology on an automated system for the determination of sodium, potassium, chioride and TCO, in human serum or plasma, and for determination of sodium, potassium and chioride in urine.

Source page: https://510kreport.com/device/K970330
Methodology: https://510kreport.com/methodology