# P000021: Dimension (R) RXL Psa Flex (R) Reagent Cartridge

- Pathway: PMA
- Applicant: Siemens Healthcare Diagnostics
- Decided: Jul 5, 2001 after 395 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K031343: Tpsa Flex Reagent Cartridge (2003), 0 descendants of its own

## Recalls of this device
- Mar 24, 2008 · Not classified · Z-1606-2008: False Results: The product may exhibit falsely elevated results. The affected lots demonstrate sporadic variability in recovery of calibrator and quality control; therefore this issue may not be readi
- Apr 21, 2003 · Not classified · Z-0873-03: test results may be inaccurate by 0.2 to 0.5 ng/mL

Source page: https://510kreport.com/device/P000021
Methodology: https://510kreport.com/methodology