Chrysalis Intelligence · Product Codes · JZO

JZO · System, Test, Thyroid Autoantibody

Immunology · 5 clearances · 3 unique sponsors

Device class
Class II
Regulation 866.5870
Total clearances
5
2020-02-27 → 2025-10-17
Last 12 months
1
Unique sponsors
3
Medical specialty
Immunology
Review panel
IM
Regulation number
866.5870
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Beckman Coulter, Inc. 2 0 2024-08-09
Roche Diagnostics 2 0 2023-09-15
Siemens Healthcare Diagnostics, Inc. 1 1 2025-10-17
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.

CodeTypeDescriptionConfidenceRationale
86376 CPT High CPT code for thyroid antibody (anti-TPO, anti-thyroglobulin) testing
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-10-17 K250250 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Anti-Thyroid Peroxidase II
2024-08-09 K240469 Beckman Coulter, Inc. Access TPO Antibody
2023-09-26 K213517 Beckman Coulter, Inc. Access Thyroglobulin Antibody II
2023-09-15 K222610 Roche Diagnostics Elecsys Anti-Tg
2020-02-27 K193313 Roche Diagnostics Elecsys Anti-TSHR