# K131536: Immulite 2000 Psa Calibration Verification Material

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Aug 12, 2013 after 75 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K993210 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112603: Access Hybritech P2PSA QC on the Access Immunoassay Systems, Beckman Coulter, Inc. (2011) Summary page 2.

## Most influential descendants
- K133816: Immulite 2000 Free Psa Calibration Verification Material (2014), 0 descendants of its own

## Indications for use
The IMMULITE® 2000 PSA Calibration Verification Material (CVM) is intended for monitoring system performance of the IMMULITE Immunoassay system for the quantitative measurement of PSA antigen.

Source page: https://510kreport.com/device/K131536
Methodology: https://510kreport.com/methodology