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# Micronics 510(k) for PanNAT E. coli Test
- URL: https://www.fdaweb.com/micronics-510-k-for-pannat-e-coli-test/
- Published: 2018-06-04T12:00:00.000Z
- Updated: 2026-09-15T00:10:02.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141594

FDA has cleared a Micronics 510(k) for its PanNAT STEC Test and its use in detecting Shiga toxin-producing *E. coli*. The test is performed in a disposable microfluidics-enabled cartridge and is a qualitative, *in vitro* nucleic acid amplification-based assay that simultaneously detects and differentiates the *stx1* and *stx2* Shiga toxins and *E.coli* O157\. The cartridge contains all of the reagents required for the test, including a novel approach for integrated positive and negative quality controls, the company says. Sample, reagents, and waste are captured in the cartridge for easy disposal, it adds.