510(k) · Cleared
ClearedAtellica IM Total PSA II (tPSAII)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Cleared on Jan 5, 2026 as substantially equivalent to P950021 (Siemens Healthcare Diagnostics, 1995) after a 222-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jan 5, 2026
- Review
- 222 days
- Class
- Class II
- Product code
- LTJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P950021 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backP950021 Advia Centaur & Advia Centaur CP Psa ImmunoassaySiemens Healthcare Diagnostics · 1995 · Recalled
- This deviceK251630 Atellica IM Total PSA II (tPSAII)Siemens Healthcare Diagnostics, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P950021 | Advia Centaur & Advia Centaur CP Psa Immunoassay | Siemens Healthcare Diagnostics | 1995 | 1 |
| 0 (this device) | K251630 | Atellica IM Total PSA II (tPSAII) | Siemens Healthcare Diagnostics, Inc. | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LTJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | P950021 | Advia Centaur & Advia Centaur CP Psa ImmunoassaySummary page 5…Regulation Number 866.6010 4. Predicate Device Information Predicate Device Name: Siemens Atellica IM PSA assay, P950021/S015 The Atellica IM tPSAII assay is substantially equivalent to the Siemens Atellica IM PSA that was approved under P950021/S015… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All LTJ devicesLTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · LTJ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LTJ
Too few LTJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LTJ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LTJ
14in 2025
MAUDE reports naming product code LTJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 17 |
| 2008 | 0 | — | 3 | 57 |
| 2009 | 0 | — | 0 | 58 |
| 2010 | 0 | — | 2 | 34 |
| 2011 | 0 | — | 0 | 109 |
| 2012 | 0 | — | 0 | 101 |
| 2013 | 1 | — | 1 | 69 |
| 2014 | 0 | — | 0 | 19 |
| 2015 | 0 | — | 0 | 14 |
| 2016 | 2 | — | 0 | 8 |
| 2017 | 10 | — | 0 | 13 |
| 2018 | 7 | — | 0 | 8 |
| 2019 | 2 | — | 0 | 11 |
| 2020 | 1 | — | 0 | 4 |
| 2021 | 2 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 2 | — | 0 | 17 |
| 2024 | 3 | — | 0 | 8 |
| 2025 | 3 | — | 1 | 14 |
| 2026 | 3 | — | 0 | — |
What is it indicated for?
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251630 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251630: Atellica IM Total PSA II (tPSAII).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251630
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026