# K070531: Ise Module and Bar Code Reader Addition for the Datapro Clinical Chemistry Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: Sep 4, 2007 after 193 days
- Product code: CGZ (Electrode, Ion-Specific, Chloride)
- Device class: 2
- Regulation: 21 CFR 862.1170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The ISE module of the DataPro TM Plus Clinical Chemistry Analyzer is intended for the quantitative determination of sodium, potassium and chloride in serum, using ion-selective (ISE) electrodes. Sodium: Disorders of the sodium ion (Na + ) can be caused by excessive loss, gain or retention of Na+ or excessive retention of water. Low Na+ can be associated with renal failure, congestive heart failure and cirrhosis. An increase in Na+ is seen in neurological disorders such as tremors, ataxia, confusion and coma. Potassium: Disturbances of potassium (K*) homeostasis has serious consequences and can lead to tachycardia when low. When high, respiratory weakness peripheral vascular collapse and cardiac arrest is evident. It is also seen in conditions associated with Addison's disease. Levels higher than 1Ommol/L are fatal in most cases. Chloride: When the chloride ion (Cr ) is unbalanced in the serum, it is usually a sign of an underlying disturbance in fluid and acid-base homeostasis. A low Cl- concentration is observed in individuals with salt-losing nephritis whereas an increase in Cor can indicate acute renal failure and metabolic acidosis. The ISE module, and all of the reagents included in this test system are for in vitro diagnostic use only.

Source page: https://510kreport.com/device/K070531
Methodology: https://510kreport.com/methodology