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# FDA Clears 2 Thermo Scientific Tests
- URL: https://www.fdaweb.com/fda-clears-2-thermo-scientific-tests/
- Published: 2022-06-09T12:00:00.000Z
- Updated: 2026-09-14T17:48:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152028

FDA has cleared Thermo Scientific 510(k)s for its EliA RNA Pol III and EliA Rib-P tests for aiding in the diagnosis of systemic sclerosis (SSc; scleroderma) and systemic lupus erythematosus (SLE). “RNA Polymerase III is a criteria marker for SSc with both diagnostic and prognostic value,” the company says. “Additionally, in patients who are positive for RNA polymerase III, up to 70% may have no other SSc associated antibodies present.”

The company says some SLE patients present with monospecific ribosomal P antibodies, and detecting these using indirect immunofluorescence has been shown to be an unreliable method. “The EliA Rib-P test is designed with optimal sensitivity and specificity and can be used to support the diagnosis of SLE, particularly in ANA \[antinuclear antibodies\] negative patients,” it says.