510(k) · Cleared
ClearedElecsys Psa (on Elecsys 1010)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Cleared on Jan 6, 1998 as substantially equivalent to K964351 (Boehringer Mannheim Corp., 1997) after a 60-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Jan 6, 1998
- Review
- 60 days
- Class
- Class II
- Product code
- LTJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964351 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK964351 Elecsys Psa AssayBoehringer Mannheim Corp. · 1997
- This deviceK974189 Elecsys Psa (on Elecsys 1010)Boehringer Mannheim Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964351 | Elecsys Psa Assay | Boehringer Mannheim Corp. | 1997 | — |
| 0 (this device) | K974189 | Elecsys Psa (on Elecsys 1010) | Boehringer Mannheim Corp. | 1998 | — |
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.
Top candidate predicates for a new LTJ device
- #1 K251630 Atellica IM Total PSA II (tPSAII)score 10.6 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K964351 | Elecsys Psa AssaySummary page 2…sma to aid in the management of prostate cancer patients. The Boehringer Mannheim Elecsys® PSA Assay has been approved for use on the Elecsys 2010 immunoassay analyzer (K964351/S1). The application of the Elecsys® PSA Assay on the Elecsys 1010 immunoassay analyzer is substantially equivalent to the same a… | 1997 |
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 no recall.
- 1 other device also cites its predicate K964351.
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.
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?
Immunoassay for the in vitro quantitative dctermination of Prostate-Specific Antigen (PSA)
in human serum and'plasma. The Elecsys PSA assay is further indicated for serial measure of
PSA to aid in the management of prostate cancer.
The eclectrochemiluminescence immunoassay “ECLIA™ is intended for use on the Bochnnger
Mannheim Elecsys 2010 and 1010 immunoassay analyzers.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974189 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974189: Elecsys Psa (on Elecsys 1010).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974189
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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