510(k) · Cleared
ClearedImmulite 2000 Psa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Cleared on Aug 22, 1997 after a 79-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 22, 1997
- Review
- 79 days
- Class
- Class II
- Product code
- LTJ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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?
The DPC IMMULITE 2000 PSA kit is intended for the quantitative measurement of prostate specific antigen (PSA) in human serum as an adjunctive test to aid in the management of prostate cancer in patients.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972095: Immulite 2000 Psa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972095
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026