Siemens Healthcare Diagnostics, Inc. · Class II · Cleared Feb 6, 2026
| K-number | K251543 |
| Device name | Atellica® IM TSH3-Ultra II (TSH3ULII) |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Product code | JLW |
| Device class | Class II |
| Decision date | Feb 6, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 862.1690 |
The Atellica® IM TSH3-Ultra II is an in vitro diagnostic assay that quantitatively measures thyroid-stimulating hormone (TSH) in human serum and plasma samples using the Atellica® IM Analyzer. The measurement is used to diagnose thyroid and pituitary disorders by detecting TSH produced by the anterior pituitary gland.
The candidate device uses direct chemiluminescent immunoassay with anti-FITC monoclonal antibody bound to paramagnetic particles, FITC-labeled anti-TSH capture antibody, and an acridinium ester tracer conjugated to anti-TSH antibody. The main differences from the predicate are a smaller sample volume (75 μL vs. 100 μL) and a lower limit of quantitation (0.008 μIU/mL vs. 0.010 μIU/mL), while maintaining the same assay range (0.008–150 μIU/mL), operating principle, and detection technology.
Performance was validated using CLSI Document EP17-A2 (detection capability), CLSI EP05-A3 (precision and reproducibility), CLSI EP09c-ed3 (assay comparison and specimen equivalency), CLSI EP07-ed3 (interference and cross-reactivity), and CLSI EP06-ed2 (linearity).
View the full FDA submission: accessdata.fda.gov