510(k) · Cleared
ClearedTpsa Flex Reagent Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Cleared on May 15, 2003 as substantially equivalent to P000021 (Siemens Healthcare Diagnostics, 2001) after a 16-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- May 15, 2003
- Review
- 16 days
- Class
- Class II
- Product code
- LTJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P000021 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backP000021 Dimension (R) RXL Psa Flex (R) Reagent CartridgeSiemens Healthcare Diagnostics · 2001 · Recalled
- This deviceK031343 Tpsa Flex Reagent CartridgeDade Behring, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P000021 | Dimension (R) RXL Psa Flex (R) Reagent Cartridge | Siemens Healthcare Diagnostics | 2001 | 2 |
| 0 (this device) | K031343 | Tpsa Flex Reagent Cartridge | Dade Behring, Inc. | 2003 | — |
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 |
|---|---|---|---|
| * | P000021 | Dimension (R) RXL Psa Flex (R) Reagent CartridgeSummary page 1…c Antigen for the detection and management of prostate cancer Predicate Device: Dade Behring TPSA Flex@ reagent cartridge (P000021/S2) Intended Use: The TPSA method for the Dimension@ clinical chemistry system with the heterogeneous immunoassay module is an… | 2001 |
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.
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 TPSA method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure prostate specific antigen (PSA) in human serum and plasma:
1. as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (D E) in men 50 years or older. Prostate biopsy is required for diagnosis of cancer
2. as an aid in the management (monitoring) of prostate cancer patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031343: Tpsa Flex Reagent Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031343
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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