Cleared Traditional

K251630 - Atellica IM Total PSA II (tPSAII)

K251630 is an FDA 510(k) clearance for Atellica IM Total PSA II (tPSAII), manufactured by Siemens Healthcare Diagnostics, Inc.. The device is a Class 2 Immunology device with product code LTJ cleared through the Traditional 510(k) pathway after a 222-day FDA review.

K251630 · Siemens Healthcare Diagnostics, Inc. · Immunology device
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Jan 2026
Decision
222d
Days
Class 2
Risk

K251630 is an FDA 510(k) clearance for the Atellica IM Total PSA II (tPSAII). Classified as Prostate-specific Antigen (psa) For Management Of Prostate Cancers (product code LTJ), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on January 5, 2026 after a review of 222 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6010 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Healthcare Diagnostics, Inc. devices

FDA 510(k) Submission Details - K251630

510(k) Number K251630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d slower than avg
Panel avg: 105d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LTJ Device Classification - Class 2, Special Controls

Product Code LTJ Prostate-specific Antigen (psa) For Management Of Prostate Cancers
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6010
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - LTJ Prostate-specific Antigen (psa) For Management Of Prostate Cancers

All 30
Devices cleared under the same product code (LTJ) and FDA review panel - the closest regulatory comparables to K251630.
FREND PSA PLUS (reagent cartridge)
K162378 · Nanoentek USA, Inc. · May 2017
FREND PSA PLUS (REAGENT CARTRIDGE)
K124056 · Nanoentek, Inc. · May 2013
TPSA FLEX REAGENT CARTRIDGE
K031343 · Dade Behring, Inc. · May 2003
PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K022177 · Bayer Diagnostics Corp. · Dec 2002
COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM
K022288 · Bayer Corp. · Dec 2002
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
K010550 · bioMerieux, Inc. · Apr 2001