JLW · Radioimmunoassay, Thyroid-Stimulating Hormone

Device class

Class II

Regulation 862.1690

Total clearances

2022-11-10 → 2026-02-06

Last 12 months

Unique sponsors

Classification details

Medical specialty

Clinical Chemistry

Review panel

Regulation number

862.1690

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Siemens Healthcare Diagnostics	4	1	2026-02-06
Genalyte, Inc.	1	0	2024-07-22
Beckman Coulter, Inc.	1	0	2022-11-10

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
84443	CPT	—	High	TSH (thyroid-stimulating hormone) radioimmunoassay quantitative

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-02-06	K251543	Siemens Healthcare Diagnostics, Inc.	Atellica® IM TSH3-Ultra II (TSH3ULII)
2025-04-25	K243570	Siemens Healthcare Diagnostics	Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)
2024-07-22	K234091	Genalyte, Inc.	Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0
2024-04-04	K233050	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur® TSH3-Ultra II (TSH3ULII)
2023-07-13	K222116	Siemens Healthcare Diagnostics, Inc.	Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)
2022-11-10	K221225	Beckman Coulter, Inc.	Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer