# K031343: Tpsa Flex Reagent Cartridge

- Pathway: 510(k) (Special)
- Applicant: Dade Behring, Inc.
- Decided: May 15, 2003 after 16 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 P000021 (2001). 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)
- P000021: Dimension (R) RXL Psa Flex (R) Reagent Cartridge, Siemens Healthcare Diagnostics (2001) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K031343
Methodology: https://510kreport.com/methodology