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# FDA Clears GEM Premier ChemSTAT IVD
- URL: https://www.fdaweb.com/fda-clears-gem-premier-chemstat-ivd/
- Published: 2019-03-06T12:00:00.000Z
- Updated: 2026-09-15T01:10:29.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143542

FDA has cleared an Instrumentation Laboratory 510(k) for the GEM Premier ChemSTAT *in vitro* diagnostic (IVD) analyzer with Intelligent Quality Management. The device is designed for rapid basic metabolic panel testing at the point of care. The company says it provides laboratory-quality results in less than 70 seconds, from venous or arterial whole blood samples.  

The IVD has three new tests — creatinine, blood urea nitrogen and measured tCO2 — in addition to sodium, potassium, ionized calcium, chloride, glucose, lactate, hematocrit, ph and pCO2\. A basic metabolic panel test is one of the most widely ordered tests for diagnosing acute conditions, such as kidney failure, insulin shock, respiratory distress, and arrhythmias, the company says.