Cleared Traditional

Atellica? CI Analyzer, Atellica? IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica? CH Albumin BCP (AlbP)

K222116 · Siemens Healthcare Diagnostics, Inc. · Chemistry
Jul 2023
Decision
360d
Days
Class 2
Risk

About This 510(k) Submission

K222116 is an FDA 510(k) clearance for the Atellica? CI Analyzer, Atellica? IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica? CH Albumin BCP (AlbP), a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on July 13, 2023, 360 days after receiving the submission on July 18, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K222116 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2022
Decision Date July 13, 2023
Days to Decision 360 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JLW — Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1690

Similar Devices — JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 241
Atellica? IM TSH3-Ultra II (TSH3ULII)
K251543 · Siemens Healthcare Diagnostics, Inc. · Feb 2026
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)
K243570 · Siemens Healthcare Diagnostics · Apr 2025
Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0
K234091 · Genalyte, Inc. · Jul 2024
ADVIA Centaur? TSH3-Ultra II (TSH3ULII)
K233050 · Siemens Healthcare Diagnostics, Inc. · Apr 2024
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
K221225 · Beckman Coulter, Inc. · Nov 2022
Elecsys TSH
K190773 · Roche Diagnostics · Apr 2019