# P930027: Immulite Systems Psa & Third Generation Psa Reagents

- Pathway: PMA
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Sep 15, 1995 after 766 days
- Product code: MTF (Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer)
- Device class: 3
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Sep 30, 2024 · Class II · Z-0464-2025: The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU).
- Dec 21, 2016 · Class II · Z-1119-2017: Negative bias with IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit. The investigation by Siemens has confirmed that patient samples exhibit an average negative bias of a
- Dec 21, 2016 · Class II · Z-1120-2017: Negative bias results with the IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit was confirmed for two lots (D0119 and D0120). The investigation by Siemens has confirmed t
- Nov 18, 2016 · Class II · Z-0884-2017: Siemens Healthcare Diagnostics has confirmed that the IMMULITE/ IMMULITE 1000 Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use.
- Nov 18, 2016 · Class II · Z-0885-2017: Siemens Healthcare Diagnostics confirmed that the IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use.
- Jun 26, 2013 · Class II · Z-2047-2013: Customers complained of a positive bias in patient results on the IMMULITE/ IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi PSA assay when compared against the IMMULITE /IMMULITE 1000 3rd Generation PSA
- May 21, 2008 · Not classified · Z-2090-2008: The field action was initiated after the firm confirmed that the Coat-A-Count PSA IRMA kit (IKPS1, 2, 5, X) exhibits a low bias, which is evident when comparing results with other methods, including t

Source page: https://510kreport.com/device/P930027
Methodology: https://510kreport.com/methodology