Cleared Traditional

Atellica IM Total PSA II (tPSAII)

K251630 · Siemens Healthcare Diagnostics, Inc. · Immunology

Jan 2026

Decision

222d

Days

Class 2

Risk

About This 510(k) Submission

K251630 is an FDA 510(k) clearance for the Atellica IM Total PSA II (tPSAII), a Prostate-specific Antigen (psa) For Management Of Prostate Cancers (Class II — Special Controls, product code LTJ), submitted by Siemens Healthcare Diagnostics, Inc. (New York, US). The FDA issued a Cleared decision on January 5, 2026, 222 days after receiving the submission on May 28, 2025. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number	K251630 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 28, 2025
Decision Date	January 05, 2026
Days to Decision	222 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	LTJ — Prostate-specific Antigen (psa) For Management Of Prostate Cancers
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.6010