510(k) · Cleared
ClearedIse Module and Bar Code Reader Addition for the Datapro Clinical Chemistry Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Fisher Scientific · CGZ Electrode, Ion-Specific, Chloride
Cleared on Sep 4, 2007 after a 193-day review. The FDA summary names no predicate by number.
- Decided
- Sep 4, 2007
- Review
- 193 days
- Class
- Class II
- Product code
- CGZ
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CGZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All CGZ devicesCGZ Electrode, Ion-Specific, Chloride: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · CGZ
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · CGZ
Too few CGZ 510(k)s in any year since 2007 to give a median.
Recalls per year · CGZ
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGZ
5in 2025
MAUDE reports naming product code CGZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 4 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 5 |
| 2012 | 0 | — | 0 | 30 |
| 2013 | 0 | — | 0 | 42 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 19 |
| 2019 | 0 | — | 2 | 3 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (199 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070531 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070531: Ise Module and Bar Code Reader Addition for the Datapro Clinical Chemistry Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070531
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026