# K251630: Atellica IM Total PSA II (tPSAII)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jan 5, 2026 after 222 days
- Product code: LTJ (Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers)
- Device class: 2
- Regulation: 21 CFR 866.6010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P950021 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P950021: Advia Centaur & Advia Centaur CP Psa Immunoassay, Siemens Healthcare Diagnostics (1995) Summary page 5.

## Indications for use
Atellica IM total PSA II (tPSAII) assay is for in vitro diagnostic use in the quantitative measurement of total prostate-specific antigen (PSA) in human serum and plasma (EDTA and lithium-heparin) using the Atellica IM Analyzer. This assay is indicated as an aid in the detection of prostate cancer in conjunction with a digital rectal exam (DRE) in men aged 50 years and older. Prostate biopsy is required for diagnosis of prostate cancer. This assay is further indicated as an aid in the management (monitoring) of patients with prostate cancer

Source page: https://510kreport.com/device/K251630
Methodology: https://510kreport.com/methodology